TIG v1.0 CDASH Metadata Staging

Observation Class,Domain,Data Collection Scenario,Implementation Options,Order Number,CDASHIG Variable,CDASHIG Variable Label,DRAFT CDASHIG Definition,Question Text,Prompt,Data Type,CDASHIG Core,Case Report Form Completion Instructions,SDTMIG Target,Mapping Instructions,Controlled Terminology Codelist Name,Subset Controlled Terminology/CDASH Codelist Name,Implementation Notes,Seq. for Order
Special-Purpose,CO,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Special-Purpose,CO,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Special-Purpose,CO,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. \n EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Special-Purpose,CO,N/A,N/A,4,COVAL,Comment,A free-text comment.,[Protocol-specified targeted question],[Abbreviated version of the protocol-specified targeted question],Char,O,[protocol specific],CO.COVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. RDOMAIN contains the domain to which the comment is related.,N/A,N/A,"If an additional free-text field is needed to provide more information about a particular record, use the COVAL variable to collect the free text, and associate the free text (comment) with the original record using RDOMAIN, IDVAR, IDVARVAL.",4
Special-Purpose,DM,Birth date collection using three date fields,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Special-Purpose,DM,Birth date collection using three date fields,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Special-Purpose,DM,Birth date collection using three date fields,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Special-Purpose,DM,Birth date collection using three date fields,N/A,4,BRTHDD,Birth Day,"Day of birth of the subject, in an unambiguous date format (e.g., DD).",What is the subject's day of birth?,Birth Day,Char,R/C,"Record the subject's day of birth (e.g., 01 or 31).",BRTHDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable BRTHDTC in ISO 8601 format.",N/A,N/A,"Day of Birth is the collected variable used for recording the day component of the Date of Birth. The sponsor may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The sponsor may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the SDTMIG variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE (SDTM expected variable), if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",4
Special-Purpose,DM,Birth date collection using three date fields,N/A,5,BRTHMO,Birth Month,"Month of birth of the subject, in an unambiguous date format (e.g., MMM).",What is the subject's month of birth?,Birth Month,Char,R/C,"Record the subject's month of birth [e.g., (in local language short month format) (JAN-DEC) or (ENE-DIE) or (JAN-DEZ), etc.].",BRTHDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable BRTHDTC in ISO 8601 format.",N/A,N/A,"Month of Birth is the collected variable used for recording the month component of the Date of Birth. The sponsor may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The sponsor may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the SDTMIG variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE (SDTM expected variable), if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",5
Special-Purpose,DM,Birth date collection using three date fields,N/A,6,BRTHYY,Birth Year,"The year of birth of the subject, in an unambiguous date format (e.g., YYYY).",What is the subject's year of birth?,Birth Year,Char,R/C,"Record the subject's year of birth (e.g., YYYY, a four-digit year).",BRTHDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable BRTHDTC in ISO 8601 format.",N/A,N/A,"Year of Birth is the collected variable used for recording the year component of the Date of Birth. The sponsor may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The sponsor may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the SDTMIG variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE (SDTM expected variable), if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",6
Special-Purpose,DM,Birth date collection using three date fields,N/A,7,BRTHTIM,Birth Time,"The time of birth of the subject, in an unambiguous time format (e.g., hh:mm).",What is the subject's time of birth?,Birth Time,Char,O,Record the time of birth (as completely as possible).,BRTHDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable BRTHDTC in ISO 8601 format.",N/A,N/A,"The level of detail collected by Time of Birth may be necessary for analysis for some pediatric, natal, or neonatal studies. The sponsor may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The sponsor may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the SDTMIG variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE (SDTMIG expected variable), if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",7
Special-Purpose,DM,Birth date collection using three date fields,N/A,8,AGE,Age,"The age of the subject, expressed in AGEU.",What is the subject's age?,Age,Num,O,Record age of the subject.,AGE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"If age is collected, it should be collected as a number and, to be correctly interpreted, the age value should be associated to a variable for the age unit. It may be necessary to know when the age was collected, as age may need to be recalculated for analysis, such as deriving age at a reference start time (RFSTDTC for SDTM). BRTHDTC may not be available in all cases (due to subject privacy concerns). If AGE is collected, then it is recommended that the date of collection also be recorded, either separately or by association to the date of the visit.",8
Special-Purpose,DM,Birth date collection using three date fields,N/A,9,AGEU,Age Units,Units of time routinely used to express the age of a person.,What is the age unit used?,Age Unit,Char,O,"Record the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, etc.).",AGEU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(AGEU),N/A,"If age is captured on the CRF, the age unit must be known to make the age value meaningful. The age unit might be collected on the CRF, in those cases where the protocol allows for any age group, or it may be pre-printed on the CRF (typically with the unit of ""years"").",9
Special-Purpose,DM,Birth date collection using three date fields,N/A,10,DMDAT,Demographics Collection Date,"The date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What is the date of collection?,Collection Date,Char,R/C,Record the date of collection using this format (DD-MON-YYYY).,DMDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable DMDTC in ISO 8601 format.",N/A,N/A,"The date of collection may be determined from the date of visit; if so, a separate date field is not needed.",10
Special-Purpose,DM,Birth date collection using three date fields,N/A,11,SEX,Sex,"Sex of the subject, as determined by the investigator.",What is the sex of the subject?,Sex,Char,R/C,"Record the appropriate sex (e.g., F (female), M (male).",SEX,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SEX),N/A,"Collect the subject's sex or gender, as reported by the investigator. This is a phenotypic assessment and not a genotypic assessment.",11
Special-Purpose,DM,Birth date collection using three date fields,N/A,12,ETHNIC,Ethnicity,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin, and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease.",Do you consider yourself Hispanic/Latino or not Hispanic/Latino?,Ethnicity,Char,O,"Study participants should self-report ethnicity, with ethnicity being asked about before race.",ETHNIC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ETHNIC),N/A,For use when values are being collected using the exact non-extensible ETHNIC codelist (C66790) values. Sponsors should refer to the FDA's Collection of Race and Ethnicity Data in Clinical Trials guidance regarding the collection of ethnicity (http://www.fda.gov/).,12
Special-Purpose,DM,Birth date collection using three date fields,N/A,13,CETHNIC,Collected Ethnicity,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin, and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease.",What is the ethnicity of the subject?,Ethnicity,Char,O,"Study participants should self-report ethnicity, with ethnicity being asked about before race.",SUPPDM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "CETHNIC" and SUPPDM.QLABEL= "Collected Ethnicity". See SDTMIG DM Domain. Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(ETHNICC),N/A,"Use when values are collected using the NCI Thesaurus codelist for Ethnicity As Collected (C128690), the extended HL7 hierarchy of codelist values, or other regulatory agency-specific controlled terminology for ethnic group. Sponsors may append a suffix to denote multiple collected ethnicities (e.g. CETHNIC1, CETHNIC2).",13
Special-Purpose,DM,Birth date collection using three date fields,N/A,14,RACE,Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Center for Disease Control).,Which of the following five racial designations best describes you? (More than one choice is acceptable.),Race,Char,R/C,"Study participants should self-report race, with race being asked about after ethnicity.",RACE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(RACE),N/A,"In the US, use RACE when collecting the 5 FDA designations for race (i.e., American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White; see (http://www.fda.gov/). See also the SDTMIG DM domain. For studies where data are collected outside the US, the recommended categories are the same except for Black instead of Black or African American. If multiple races are collected, an alternate sponsor-defined variable structure would be required. Sponsors may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g., RACE1, RACE2) and populate RACE with the value MULTIPLE.",14
Special-Purpose,DM,Birth date collection using three date fields,N/A,15,CRACE,Collected Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Centers for Disease Control).,Which of the following racial designations best describes you? (More than 1 choice is acceptable.),Race,Char,R/C,"Study participants should self-report race, with race being asked about after ethnicity. (The FDA guidance suggests that individuals be permitted to designate a multiracial identity. Check all that apply at the time of collection).",SUPPDM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPDM dataset as the value of SUPPDM.QVAL when SUPPDM.QNAM = "CRACE" and SUPPDM.QLABEL="Collected Race". See the SDTMIG DM domain.,(RACEC),N/A,"Use CRACE when more detailed race categorizations are desired (e.g., more than the 5 FDA). The HL7 Reference Information Model Structural Vocabulary Tables are designed to collapse up to the SDTM variable RACE with CT (e.g., American Indian or Alaska Native Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White). If sponsors choose to map the extended Race codelist values to RACE CT (e.g., Japanese to Asian), then this mapped variable would be reported using the SDTMIG variable RACE. Sponsors should refer to the FDA guidance (http://www.fda.gov/). For studies where data are collected outside the US, the recommended categories are the same except for Black instead of Black or African American. If multiple races are collected, an alternate sponsor-defined variable structure would be required. Sponsors may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g. CRACE1, CRACE2) and populate CRACE with the value MULTIPLE.",15
Special-Purpose,DM,Birth date collection using three date fields,N/A,16,RACEOTH,Race Other,"A free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values.",What was the other race?,Specify Other Race,Char,O,"If none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values, record the value in this free text field.",SUPPDM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "RACEOTH" and SUPP.QLABEL="RACE OTHER". See SDTMIG DM Domain. Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,N/A,N/A,"When creating the DM form, it is suggested that the 5 standard race categories be included. Sponsors may choose to include another value (""Specify, Other"") with a free-text field for extending the list of values. The RACEOTH variable contains the free text added by the site. The value(s) added in the optional variable might or might not collapse up into 1 of the 5 FDA categories. See SDTMIG DM domain examples for reporting this implementation.",16
Special-Purpose,DM,Birth date collection using a single date field,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",17
Special-Purpose,DM,Birth date collection using a single date field,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",18
Special-Purpose,DM,Birth date collection using a single date field,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",19
Special-Purpose,DM,Birth date collection using a single date field,N/A,4,BRTHDAT,Birth Date,"A subject's date of birth (with or without the time of birth). The complete Date of Birth is made from the temporal components of Birth Year, Birth Month, Birth Day, and Birth Time..",What is the subject's date of birth?,Birth Date,Char,R/C,"Record the date of birth to the level of precision known (e.g., day/month/year, year, month/year) in this format (DD-MON-YYYY).",BRTHDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable BRTHDTC in ISO 8601 format.",N/A,N/A,"BRTHDAT is the collected field used for recording the full birth date. The sponsor may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The sponsor may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, selected components) is reported in the SDTMIG variable BRTHDTC in ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE (SDTM expected variable), if not collected on the CRF, should be derived using a documented algorithm that describes how age was determined and/or imputed for those birth dates collected with reduced precision.",20
Special-Purpose,DM,Birth date collection using a single date field,N/A,5,BRTHTIM,Birth Time,"The time of birth of the subject, in an unambiguous time format (e.g., hh:mm).",What is the subject's time of birth?,Birth Time,Char,O,Record the time of birth (as completely as possible).,BRTHDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable BRTHDTC in ISO 8601 format.",N/A,N/A,"The level of detail collected by Time of Birth may be necessary for analysis for some pediatric, natal, or neonatal studies. Sponsors may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The sponsor may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the SDTMIG variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE (SDTMIG expected variable), if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",21
Special-Purpose,DM,Birth date collection using a single date field,N/A,6,AGE,Age,"The age of the subject, expressed in AGEU.",What is the subject's age?,Age,Num,O,Record age of the subject.,AGE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"If age is collected, it should be collected as a number and, to be correctly interpreted, the age value should be associated to a variable for the age unit. It may be necessary to know when the age was collected, as age may need to be recalculated for analysis, such as deriving age at a reference start time (RFSTDTC for SDTM). BRTHDTC may not be available in all cases (due to subject privacy concerns). If AGE is collected, then it is recommended that the date of collection also be recorded, either separately or by association to the date of the visit.",22
Special-Purpose,DM,Birth date collection using a single date field,N/A,7,AGEU,Age Units,Units of time that are routinely used to express the age of a person,What is the age unit used?,Age Unit,Char,O,"Record the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, etc.).",AGEU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(AGEU),N/A,"If age is captured on the CRF, the age unit must be known to make the age value meaningful. The age unit might be collected on the CRF, in those cases where the protocol allows for any age group, or it may be pre-printed on the CRF (typically with the unit of ""years"").",23
Special-Purpose,DM,Birth date collection using a single date field,N/A,8,DMDAT,Demographics Collection Date,"The date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What is the date of collection?,Collection Date,Char,R/C,Record the date of collection using this format (DD-MON-YYYY).,DMDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable DMDTC in ISO 8601 format.",N/A,N/A,"The date of collection may be determined from the date of visit; if so, a separate date field is not needed.",24
Special-Purpose,DM,Birth date collection using a single date field,N/A,9,SEX,Sex,"Sex of the subject, as determined by the investigator.",What is the sex of the subject?,Sex,Char,R/C,"Record the appropriate sex (e.g., F (female), M (male).",SEX,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SEX),N/A,"Collect the subject's sex or gender, as reported by the investigator. This is a phenotypic assessment and not a genotypic assessment.",25
Special-Purpose,DM,Birth date collection using a single date field,N/A,10,ETHNIC,Ethnicity,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease..",Do you consider yourself Hispanic/Latino or not Hispanic/Latino?,Ethnicity,Char,O,"Study participants should self-report ethnicity, with ethnicity being asked about before race.",ETHNIC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ETHNIC),N/A,For use when values are being collected using the exact non-extensible ETHNIC codelist (C66790) values. Sponsors should refer to the FDA's Collection of Race and Ethnicity Data in Clinical Trials guidance regarding the collection of ethnicity (http://www.fda.gov/).,26
Special-Purpose,DM,Birth date collection using a single date field,N/A,11,CETHNIC,Collected Ethnicity,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences, and often a common genetic heritage; these features may be reflected in their experience of health and disease.",What is the ethnicity of the subject?,Ethnicity,Char,O,"Study participants should self-report ethnicity, with ethnicity being asked about before race.",SUPPDM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "CETHNIC" and SUPPDM.QLABEL= "Collected Ethnicity". See SDTMIG DM domain. Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(ETHNICC),N/A,"Use when values are collected using the NCI Thesaurus codelist for Ethnicity As Collected (C128690), the extended HL7 hierarchy of codelist values, or other regulatory agency-specific controlled terminology for ethnic group. Sponsors may append a suffix to denote multiple collected ethnicities (e.g. CETHNIC1, CETHNIC2).",27
Special-Purpose,DM,Birth date collection using a single date field,N/A,12,RACE,Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Center for Disease Control).,Which of the following five racial designations best describes you? (More than one choice is acceptable.),Race,Char,R/C,"Study participants should self-report race, with race being asked about after ethnicity.",RACE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(RACE),N/A,"In the US, use RACE when collecting the 5 FDA designations for race (i.e., American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White; see (http://www.fda.gov/). See also the SDTMIG DM domain. For studies where data are collected outside the US, the recommended categories are the same except for Black instead of Black or African American. If multiple races are collected, an alternate sponsor-defined variable structure would be required. Sponsors may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g., RACE1, RACE2) and populate RACE with the value MULTIPLE.",28
Special-Purpose,DM,Birth date collection using a single date field,N/A,13,CRACE,Collected Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Centers for Disease Control).,Which of the following racial designations best describes you? (More than one choice is acceptable.),Race,Char,R/C,"Study participants should self-report race, with race being asked about after ethnicity. (The FDA guidance suggests that individuals be permitted to designate a multiracial identity. Check all that apply at the time of collection).",SUPPDM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPDM dataset as the value of SUPPDM.QVAL when SUPPDM.QNAM = "CRACE" and SUPPDM.QLABEL="Collected Race". See SDTMIG DM Domain.,(RACEC),N/A,"Use CRACE when more detailed race categorizations are desired (e.g., more than the 5 FDA). The HL7 Reference Information Model Structural Vocabulary Tables are designed to collapse up to the SDTM variable RACE with CT (e.g., American Indian or Alaska Native Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White). If sponsors choose to map the extended Race codelist values to RACE CT (e.g., Japanese to Asian), then this mapped variable would be reported using the SDTMIG variable RACE. Sponsors should refer to the FDA guidance (http://www.fda.gov/). For studies where data are collected outside the US, the recommended categories are the same except for Black instead of Black or African American. If multiple races are collected, an alternate sponsor-defined variable structure would be required. Sponsors may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g. CRACE1, CRACE2) and populate CRACE with the value MULTIPLE.",29
Special-Purpose,DM,Birth date collection using a single date field,N/A,14,RACEOTH,Race Other,"A free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values.",What was the other race?,Specify Other Race,Char,O,"If none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values, record the value in this free-text field.",SUPPDM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "RACEOTH" and SUPP.QLABEL="RACE OTHER". See SDTMIG DM Domain. Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,N/A,N/A,"When creating the DM form, it is suggested that the 5 standard FDA race categories be included. Sponsors may choose to include another value (""Specify, Other"") with a free-text field for extending the list of values. The RACEOTH variable contains the free text added by the site. The value(s) added in the optional variable might or might not collapse up into one of the 5 FDA categories. See SDTMIG DM domain examples for reporting this implementation.",30
Interventions,CM,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",1
Interventions,CM,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: For single-site studies, this is typically pre-printed in the header of each CRF page. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,CM,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. \n EDC: The subject identifiers may be system-generated. \n This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Interventions,CM,N/A,N/A,4,CMCAT,Category for Medication,A grouping of topic-variable values based on user-defined characteristics.,What is the category for the (concomitant) [medication/treatment/therapy]?,(Concomitant) [Medication/Treatment/Therapy Category]; NULL,Char,O,"Record the (concomitant) [medication/treatment/therapy] category, if not pre-printed on the CRF.",CMCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",4
Interventions,CM,N/A,N/A,5,CMSCAT,Subcategory for Medication,A sub-division of the CMCAT values based on user-defined characteristics.,What is the subcategory for the (concomitant) [medication/treatment/therapy]?,(Concomitant) [Medication/Treatment/Therapy subcategory]; NULL,Char,O,"Record (concomitant) [medication/treatment/therapy] subcategory, if not pre-printed on the CRF.",CMSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer.,5
Interventions,CM,N/A,N/A,6,CMYN,Any Concomitant Medications Taken,An indication of whether any (concomitant) medications/treatments/therapies were taken/given.,Were/Was any (concomitant) [medication(s)/treatment(s)/therapy(ies)] taken?,Any (Concomitant) [Medication(s)/Treatment(s)/Therapy(ies)],Char,O,"Indicate if the subject took any (concomitant) [medications/treatments]. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,6
Interventions,CM,N/A,N/A,7,CMSPID,CM Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.",CMSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medication/treatment records with AEs and/or MH. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",7
Interventions,CM,N/A,N/A,8,CMTRT,"Reported Name of Drug, Med, or Therapy",Verbatim medication name or treatments (include only treatments with data collection characteristics similar to medications).,What was the (concomitant) [medication/treatment/therapy] (name/term)?,(Concomitant) [Medication/Treatment/Therapy],Char,HR,Record only 1 [medication/treatment/therapy] per line. Provide the full trade or proprietary name of the [medication/treatment/therapy]; otherwise the generic name may be recorded.,CMTRT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"In most cases, the verbatim drug names or treatment will be coded to a standard dictionary (e.g., WHODrug) after data have been collected on the CRF. For the collection of verbatim drug name or treatments, the recommendation is for sites to provide the full trade or proprietary name, which is more exact than the generic. The full trade name provides the base generic and the appropriate salt for that particular drug. In addition, for coding purposes, it helps with ATC selection (e.g., Tylenol with codeine #1 has a different ATC code than Tylenol with codeine #3). This field can be used for either prior or concomitant medication/treatments.",8
Interventions,CM,N/A,N/A,9,CMPRESP,CM Pre-Specified,An indication that a specific intervention or a group of interventions is pre-specified on a CRF.,N/A,N/A,Char,O,N/A,CMPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"For pre-specified interventions, this is a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both pre-specified and free-text interventions, the value of CMPRESP should be ""Y"" for all pre-specified interventions and null for interventions reported as free text.",9
Interventions,CM,N/A,N/A,10,CMOCCUR,CM Occurrence,An indication whether the prespecified medication/treatment/therapy (CMTRT) or the group of medications/treatments/therapies was administered when information about the occurrence of a specific intervention was solicited.,Did the subject take [prespecified (concomitant) medication/treatment/therapy/dose]?; Has the subject taken [prespecified (concomitant) medication/treatment/therapy/dose]?,[Specific (Concomitant) [Medication/Treatment/Therapy],Char,O,Indicate if [specific medication/treatment] was taken by checking Yes or No.,CMOCCUR,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. If the question was not asked or answered, populate the SDTMIG variable CMSTAT with ""NOT DONE"".",(NY),N/A,CMOCCUR is used to report the occurrence of a pre-specified medication/treatment. CMOCCUR is not used for spontaneously free-text reported concomitant medication/treatments. The site should be able to indicate that the question was not asked or answered.,10
Interventions,CM,N/A,N/A,11,CMINGRD,Concomitant Meds Active Ingredients,Medication ingredients.,What were the active ingredients?,Active Ingredients,Char,O,"Prior to a subject's clinical visit, remind all subjects to bring all medications bottles, packs etc. they are taking with them to their clinical visit. Record all active ingredient(s) off the medication label and separate each ingredient with a comma for the name of drug medication or treatment taken. For example, the medication Dolmen, if manufactured in Spain, the active ingredients should be collected as noted below: Active Ingredient: Acetylsalicylic Acid, Ascorbic acid, codeine phosphate.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,N/A,N/A,"This may be collected in addition to the medication/treatment name. Collecting this provides more detailed information when coding to a medication dictionary like WHODrug Dictionary Enhanced Format C, which codes to the ingredient level for many trade-name medications. For example, depending on the country where it is manufactured, the active ingredients in the medication dolmen may be different: In Spain, acetylsalicylic acid, ascorbic acid, codeine phosphate; in Italy and Czech Republic, tenoxicam; in Estonia and Latvia, dexketoprofen trometamol.",11
Interventions,CM,N/A,N/A,12,CMINDC,CM Indication,"The condition, disease, symptom, or disorder that the concomitant (non-study) medication/treatment/therapy was used to address or investigate (e.g., why the medication/treatment/therapy was taken or administered).",For what indication was the (concomitant) [medication/treatment/therapy] taken?,Indication,Char,R/C,"Record the reason the medication was taken based on clinical investigator's evaluation. If taken to treat a condition, and a diagnosis was made, the indication should be the diagnosis. If taken to treat a condition, and no diagnosis was made, the indication should be the signs and symptoms. If taken as prophylaxis, report as ""Prophylaxis for "" and include a description of the condition(s).",CMINDC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This is not the pharmacological/therapeutic classification of an agent (e.g., antibiotic, analgesic), but rather the reason for its administration to the subject. This additional information is collected on the CRF when sponsors want to capture the reason(s) a subject took a medication/treatment. This information could be used as deemed appropriate for coding; analysis (e.g., in the classification of medications); reconciling medications/treatments taken by a subject with provided medical history; and/or AEs/SAEs, as part of the data clean-up and monitoring process.",12
Interventions,CM,N/A,N/A,13,CMAENO,Related Adverse Event ID,Identifier for the adverse event that is the indication for this medication/treatment/therapy.,What was the identifier for the adverse event(s) for which the (concomitant) [medication/treatment/therapy] was taken?,Adverse Event Identifier,Char,O,Record the identifier of the Adverse Event for which this (concomitant) [medication/treatment/therapy] was taken.,N/A,"This does not map directly to an SDTMIG variable. For SDTM submission datasets, may be used to create RELREC to link this record with a record in the AE domain.",N/A,N/A,The intent is to establish a link between the medication/treatment and the AE that was reported. CMAENO can be used to identify a relationship between records in CM dataset and records in the AE dataset. See the SDTMIG for information on RELREC.,13
Interventions,CM,N/A,N/A,14,CMMHNO,Related Medical History Event ID,Identifier for the medical history condition that is the indication for this medication/treatment/therapy.,What was the identifier for the medical history event(s) for which the (concomitant) [medication/treatment/therapy] was taken?,Medical History Event Identifier,Char,O,Record the identifier of the medical history event for which this (concomitant) [medication/treatment/therapy] was taken.,N/A,"This does not map directly to an SDTMIG variable. For SDTM submission datasets, may be used to create RELREC to link this record with a record in the MH domain.",N/A,N/A,The intent is to establish a link between the medical history condition and the medication/treatment taken for the condition. CMMHNO can be used to identify a relationship between records in the CM dataset and records in the MH dataset. See the SDTMIG for information on RELREC.,14
Interventions,CM,N/A,N/A,15,CMDOSE,CM Dose per Administration,"The dose of medication/treatment (e.g., --TRT ) given at one time, represented as a numeric value.",What was the individual dose (of the concomitant [medication/treatment/therapy] per administration)?,[Dose/Amount] (per administration),Num,O,"Record the dose of (concomitant) [medication/treatment] taken per administration (e.g., 200).",CMDOSE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Used when the dose/amount taken/administered/consumed has only numeric entries. If non-numeric entries are possible, use the CDASH field CMDSTXT.",15
Interventions,CM,N/A,N/A,16,CMDSTXT,Concomitant Meds Dose Description,The dose of medication/treatment taken per administration.,What was the individual dose of the (concomitant) [medication/treatment/therapy]?,Dose,Char,O,"Record the dose of (concomitant) [medication/treatment] taken per administration (e.g., 200).",CMDOSTXT; CMDOSE,"This does not map directly to an SDTMIG variable. Numeric values map to CMDOSE in SDTM. Non-numeric values (e.g., ""200-400"") map to CMDOSTXT in SDTM.",N/A,N/A,"Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text, or ranges. The data collected in this text-format field should be separated or mapped to either SDTMIG CMDOSE if numeric or CMDOSTXT if text.",16
Interventions,CM,N/A,N/A,17,CMDOSTOT,CM Total Daily Dose,"The total amount of CMTRT taken over a day, using the units in CMDOSU.",What was the total daily dose of the (concomitant) [medication/treatment/therapy]?,Total Daily Dose,Num,O,Record the total dose of (concomitant) [medication/treatment/therapy] taken daily.,CMDOSTOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"For use when only total daily dose is collected on the CRF. For general medications/treatments, it is not recommended to use Total Daily Dose. Instead, this can be calculated from other fields (e.g., Units, Dose, Frequency).",17
Interventions,CM,N/A,N/A,18,CMDOSU,CM Dose Units,"The unit associated with the concomitant medication/treatment/therapy taken (e.g., mg in ""2 mg 3 times per day"").",What is the unit (for the dose of concomitant [medication/treatment/therapy])?,(Dose) Unit,Char,R/C,"Record the dose unit of the dose of concomitant [medication/treatment/therapy] taken (e.g., mg.).",CMDOSU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),(CMDOSU),"When sponsors collect data for amount of dose taken (i.e., Dose, Total Daily Dose), Unit must be collected as well (if applicable).",18
Interventions,CM,N/A,N/A,19,CMDOSFRM,CM Dose Form,The pharmaceutical dosage form in which the CMTRT is physically presented.,What was the dose form of the (concomitant) [medication/treatment/therapy]?,Dose Form,Char,O,"Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the concomitant [medication/treatment/therapy] taken.",CMDOSFRM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FRM),(CMDOSFRM),"Some drugs have multiple forms; this field may be needed to code the drug to an ATC level. However, in general, this level of detail should not be necessary except for medications/treatments of interest.",19
Interventions,CM,N/A,N/A,20,CMDOSFRQ,CM Dosing Frequency per Interval,The number of doses given/administered/taken during a specific interval.,What was the frequency of the (concomitant) [medication/treatment/therapy]?,Frequency,Char,O,"Record how often the (concomitant) [medication/treatment/therapy] was taken (e.g., BID, PRN).",CMDOSFRQ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FREQ),(CMDOSFRQ),"The frequency of the concomitant medication/treatment. When collected, the recommendation is to collect dosing information in separate fields (e.g., CMDOSE, CMDOSEU, CMDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.",20
Interventions,CM,N/A,N/A,21,CMROUTE,CM Route of Administration,The route of administration of the concomitant medication/treatment/therapy.,What was the route of administration of the (concomitant) [medication/treatment/therapy]?,Route,Char,R/C,Provide the route of administration for the (concomitant) [medication/treatment/therapy].,CMROUTE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ROUTE),(CMROUTE),"This additional information may be important to collect on the CRF when the sponsor wants to capture a medication's/treatment's route of administration, for purposes such as coding; also, the medication/treatment may have more than 1 route. Some companies may use route in coding medications/treatments, to be able to choose a precise preferred name and ATC code.",21
Interventions,CM,N/A,N/A,22,CMSTDAT,Concomitant Meds Start Date,"The start date is when the concomitant medication/treatment/therapy was first taken, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (concomitant) [medication/treatment/therapy/dose] start date?,Start Date,Char,R/C,"Record the date the concomitant [medication/treatment] was first taken using this format (DD-MON-YYYY). If the subject has been taking the concomitant [medication/treatment] for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Concomitant [medication/treatment] taken during the study are expected to have a complete start date. Prior concomitant [medication/treatment] that are exclusionary should have both a start and end date.",CMSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable CMSTDTC in ISO 8601 format.",N/A,N/A,"The assumption is that sponsors should either have a Start Date or will indicate that the medication or therapy was started before, during, or after the study period. The preferred method is to collect a complete Start Date. Partial dates (e.g., providing year only) for medications/treatment started a considerable amount of time prior to the start of study are acceptable.",22
Interventions,CM,N/A,N/A,23,CMSTTIM,Concomitant Meds Start Time,"The time the concomitant medication/treatment/therapy was started, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (concomitant) [medication/treatment/therapy/dose] start time?,Start Time,Char,R/C,Record the time (as complete as possible) that the concomitant [medication/treatment] was started.,CMSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable CMSTDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a concomitant medication/treatment was started only when a protocol or data collection scenarios supports it. Typically, a start time is not collected unless the subject is under the direct care of the site at the time a concomitant medication/treatment administered or the subject records the start time in a diary.",23
Interventions,CM,N/A,N/A,24,CMPRIOR,Prior Concomitant Meds,Indication the concomitant medication/treatment/therapy was given or taken prior to [CMSTTPT] or prior to the date in DM.RFSTDTC.,Was the (concomitant) [medication/treatment/therapy] given/taken prior to [CMSTTPT]?; Was the (concomitant) [medication/treatment/therapy] given/taken prior to study start?,Prior to [CMSTTPT]; Prior to Study,Char,O,Check if the concomitant [medication/treatment/therapy] was started before the study.,CMSTRF; CMSTRTPT,"This does not map directly to an SDTMIG variable. May be used to populate a value into an SDTM relative timing variable such as CMSTRF or CMSTRTPT. When populating CMSTRF, or CMSTRTPT, if the value of the CDASH field CMPRIOR is ""Y"" a value from the CDISC CT (STENRF) may be used. When CMPRIOR refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC), the SDTM variable CMSTRF should be populated. When CMPRIOR is compared to another time point, the SDTM variables CMSTRTPT and CMSTTPT should be used. Note: CMSTRTPT must refer to the time-point anchor described in CMSTTPT.",(NY),N/A,"Sponsors may collect this information rather than start dates. See Section 3.7, Mapping Relative Times from Collection to Submissions, and the SDTMIG for more information.",24
Interventions,CM,N/A,N/A,25,CMONGO,Ongoing Concomitant Meds,Indication the concomitant medication/treatment/therapy is ongoing when no end date is provided.,Was the (concomitant) [medication/treatment/therapy] ongoing (as of [the study-specific time point or period])?,Ongoing (as of [the study-specific time point or period]),Char,R/C,"Record the concomitant [medication/treatment/therapy] as ongoing if the subject has not stopped taking the concomitant [medication/treatment/therapy] at [the timepoint defined by the study]. If the concomitant medication is ongoing, the end date should be left blank",CMENRF; CMENRTPT,"This does not map directly to an SDTM variable. May be used to populate a value into an SDTMIG relative timing variable (e.g., CMENRF, CMENRTPT). When populating CMENRF, if the value of CMONGO is ""Y"", the values of ""DURING"", ""AFTER"", or ""DURING/AFTER"" may be used. When populating CMENRTPT, if the value of CMONGO is ""Y"", the value of ""ONGOING"" may be used. When CMONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTM variable CMENRF should be populated. When CMONGO is used in conjunction with another time point, the SDTM variables CMENRTPT and CMENTPT should be used. Note: CMENRTPT must refer to a time-point anchor described in CMENTPT.",(NY),N/A,"This box should be checked to indicate that the concomitant medication/treatment has not stopped at the time of data collection. It is expected that every recorded medication/treatment should have either an end date or be checked as ongoing, but not both. However, in cases where ongoing concomitant medications/treatments are not permitted, it may not be necessary to include an Ongoing field in the CRF. See Section 3.7, Mapping Relative Times from Collection to Submission, for more information about collecting relative date/time; see the SDTMIG for information about mapping relative times.",25
Interventions,CM,N/A,N/A,26,CMENDAT,Concomitant Meds End Date,"The date that the subject ended/stopped taking the concomitant medication/treatment/therapy, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (concomitant) [medication/treatment/therapy/dose] end date?,End Date,Char,R/C,Record the date the concomitant [medication/treatment] was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant [medication/treatment] leave this field blank.,CMENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable CMENDTC in ISO 8601 format.",N/A,N/A,"The assumption is that sponsors should either have an End Date or will indicate that the medication or therapy was ongoing at the time of collection or at the end of the study. However, in cases where the end date can be determined from dates collected elsewhere in the CRF it is not necessary to include an End Date field on the CRF. For example, if all concomitant medications/treatments are administered only once during a trial, the end date will be the same as the start date.",26
Interventions,CM,N/A,N/A,27,CMENTIM,Concomitant Meds End Time,"The time when the subject ended/stopped taking the concomitant medication/treatment/therapy, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [medication/treatment/therapy/dose] end time?,End Time,Char,R/C,Record the time (as complete as possible) that the concomitant medication/treatment was stopped.,CMENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable CMENDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a concomitant medication or treatment was ended only when a protocol or data collection scenario requires it or the subject records the end time in a diary. Typically, an end time is not collected unless the subject is under the direct care of the site at the time a concomitant medication/treatment is stopped.",27
Interventions,CM,N/A,N/A,28,CMRSDISC,Reason for Treatment Discontinuation,The reason the treatment was discontinued.,What was the reason the (concomitant) [medication/treatment/therapy/ --TRT] was [discontinued/stopped/ended]?,Reason for discontinuation of concomitant medication/treatment,Char,O,Record the reason the concomitant medication/treatment was stopped.,CMRSDISC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although frequently used for prior meds, this can be used for any intervention at any timepoint. \n When the dosing of a treatment is recorded over multiple successive records, this variable is applicable only for the (chronologically) last record for the treatment.",28
Interventions,CM,N/A,N/A,29,CMDECOD,Standardized Medication Name,"The dictionary or sponsor-defined standardized text description of the topic variable, CMTRT, or the modified topic variable (CMMODIFY), if applicable.",N/A,N/A,Char,O,N/A,CMDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This field does not typically appear on the CRF. Sponsors will populate this through the coding process. Equivalent to the generic drug name in published (e.g., WHODrug, SNOMED, ICD9) or sponsor-defined dictionaries.",29
Interventions,CM,N/A,N/A,30,CMCLAS,CM Medication Class,The class for the intervention (often obtained from a coding dictionary).,N/A,N/A,Char,O,N/A,CMCLAS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This would generally be the class used for analysis.,30
Interventions,CM,N/A,N/A,31,CMCLASCD,CM Medication Class Code,The assigned dictionary code for the class for the intervention.,N/A,N/A,Num,O,N/A,CMCLASCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This would generally be the class code used for analysis.,31
Interventions,CM,N/A,N/A,32,CMATC1,ATC Level 1 Description,Dictionary text description of the first level of hierarchy within the Anatomical Therapeutic Chemical (ATC) classification system; indicates the anatomical main group.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC1" and SUPPCM.QLABEL="ATC Level 1 Description". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,32
Interventions,CM,N/A,N/A,33,CMATC1CD,ATC Level 1 Code,Dictionary code denoting the first level of hierarchy within the ATC classification system; indicates the anatomical main group.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM ="MATC1CD" and SUPPCM.QLABEL="ATC Level 1 Code". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,33
Interventions,CM,N/A,N/A,34,CMATC2,ATC Level 2 Description,Dictionary text description for the second level of hierarchy within the ATC classification system; indicates the therapeutic main group.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC2" and SUPPCM.QLABEL="ATC Level 2 Description". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,34
Interventions,CM,N/A,N/A,35,CMATC2CD,ATC Level 2 Code,Dictionary code denoting the second level of hierarchy within the ATC classification system; indicates the therapeutic main group.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC2CD" and SUPPCM.QLABEL="ATC Level 2 Code". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,35
Interventions,CM,N/A,N/A,36,CMATC3,ATC Level 3 Description,Dictionary text description of the third level of hierarchy within the ATC classification system; indicates the therapeutic/pharmacological subgroup.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC3" and SUPPCM.QLABEL="ATC Level 3 Description". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,36
Interventions,CM,N/A,N/A,37,CMATC3CD,ATC Level 3 Code,Dictionary code denoting the third level of hierarchy within the ATC classification system; indicates the therapeutic/pharmacological subgroup.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC3CD" and SUPPCM.QLABEL="ATC Level 3 Code". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,37
Interventions,CM,N/A,N/A,38,CMATC4,ATC Level 4 Description,Dictionary text description of the fourth level of hierarchy within the ATC classification system; indicates the chemical/therapeutic/pharmacological subgroup.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC4" and SUPPCM.QLABEL="ATC Level 4 Description". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,38
Interventions,CM,N/A,N/A,39,CMATC4CD,ATC Level 4 Code,Dictionary code denoting the fourth level of hierarchy within the ATC classification system; indicates the chemical/therapeutic/pharmacological subgroup.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC4CD" and SUPPCM.QLABEL="ATC Level 4 Code". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,39
Interventions,CM,N/A,N/A,40,CMATC5,ATC Level 5 Description,Dictionary text description of the fifth level of hierarchy within the ATC classification system; indicates the chemical substance.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC5" and SUPPCM.QLABEL="ATC Level 5 Description". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,40
Interventions,CM,N/A,N/A,41,CMATC5CD,ATC Level 5 Code,Dictionary code denoting the fifth level of hierarchy within the ATC classification system; indicates the chemical substance.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC5CD" and SUPPCM.QLABEL="ATC Level 5 Code". Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the sponsor's coding process.,41
Interventions,EC,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Interventions,EC,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,EC,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. \n EDC: The subject identifiers may be system generated. \n This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Interventions,EC,N/A,N/A,4,EPOCH,Epoch,Name of the trial epoch with which this element of the arm is associated.,What is the trial epoch?,[Epoch](Period/Phase/Sponsor-defined phrase),Char,R/C,[protocol specific],EPOCH,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EPOCH),N/A,"If the same information is collected more than once in different periods/parts of a study (e.g., Disposition), EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as the title of the page. See SDTMIG for further information regarding EPOCH.",4
Interventions,EC,N/A,N/A,5,ECYN,Any Study Treatment Taken,An indication of whether the subject took the study medication/ treatment.,Were any[study treatment/dose] taken?,Any Study Treatments,Char,O,"Indicate if the subject took any study medications. If Yes, include the appropriate details where indicated.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,"The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank. The ECYN is meant to indicate that the exposure as collected form should be completed or inserted into the case book. ECOCCUR would be used when the actual drug name is pre-printed on the CRF. While these might be equivalent in a single-drug study, there are differences in how they would be used in most trials. Therefore, it does not map into the SDTM variable ECOCCUR; ECOCCUR indicates whether the subject was actually administered treatment/medication. If actual treatment data is available (ECYN =""Y""), ECOCCUR may be populated based on whether subject was actually administered treatment/medication.",5
Interventions,EC,N/A,N/A,6,ECCAT,Category of Treatment,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the [study treatment/dose]?,[Study Treatment Category]; NULL,Char,O,"Record the study treatment category, if not pre-printed on the CRF.",ECCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading.",6
Interventions,EC,N/A,N/A,7,ECSCAT,Subcategory of Treatment,A sub-division of the ECCAT values based on user-defined characteristics.,What is the subcategory of the [study treatment/dose]?,[Study Treatment Subcategory]; NULL,Char,O,"Record the study treatment subcategory, if not pre-printed on the CRF.",ECSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. ECSCAT can only be used if there is an ECCAT and it must be a subcategorization of ECCAT.,7
Interventions,EC,N/A,N/A,8,ECTRT,Treatment,Name of the intervention or treatment known to the subject and/or administrator.,What was the [study treatment/investigational product] name?,[Study Treatment/Investigational Product Name],Char,R/C,Record the name of study treatment.,ECTRT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"ECTRT is the name of the intervention or treatment known to the subject and/or administrator and it is the SDTM topic variable. It is a required variable in SDTM and must have a value in CDASH or a plan to populate it in the SDTM submission datasets (i.e., collected or populated from other sources). If, in a masked study, treatment is collected and known as tablet A to the subject or administrator, then ECTRT=""TABLET A"". If, in a masked study, the treatment is not known by a synonym and the data are to be exchanged between sponsors, partners, and/or regulatory agency(s), then assign ECTRT the value of ""MASKED"".",8
Interventions,EC,N/A,N/A,9,ECPRESP,Exposure as Collected Pre-Specified,An indication that a specific intervention or a group of interventions is pre-specified on a CRF.,N/A,N/A,Char,O,N/A,ECPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"For pre-specified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both pre-specified and free-text interventions, the value of ECPRESP should be ""Y"" for all pre-specified interventions and null for interventions reported as free text.",9
Interventions,EC,N/A,N/A,10,ECOCCUR,Exposure as Collected Occurrence,An indication whether the study treatment was administered when information about the occurrence of a specific intervention was solicited.,Was [study treatment/dose] administered?; Has the subject taken [study treatment/dose]?,[Study Medication/Treatment],Char,O,"Indicate if the subject took study treatment. If Yes, include the appropriate details where indicated.",ECOCCUR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. Not applicable when ECMOOD is "Scheduled".,(NY),N/A,ECOCCUR is used to indicate whether the subject was actually administered treatment/medication. ECOCCUR should not be used to indicate that the question was not asked or answered.,10
Interventions,EC,N/A,N/A,11,ECREASOC,Exposure Reason for Occur Value,An explanation for why a scheduled study treatment administration did or did not occur.,What was the reason that the[study treatment/dose] was (not)taken?,Reason (Not) Taken,Char,O,Indicate why the study treatment was or wasnot taken.,SUPPEC.QVAL,This information could be submitted in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM="ECREASOC" and SUPPEC.QLABEL ="Reason for Occur Value". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,N/A,N/A,"The reason the study treatment was or was not taken may be chosen from a sponsor-defined codelist (e.g., SUBJECT MISTAKE, SUBJECT REFUSED) or entered as free text. When --REASOC is used, --OCCUR must also be populated in the SDTM dataset with a value of ""Y"" or ""N"".",11
Interventions,EC,N/A,N/A,12,ECMOOD,Exposure as Collected Mood,Mode or condition of the record specifying whether the intervention (activity) is intended to happen or has happened.,Does this record describe scheduled [study treatment/dose] or performed [study treatment/dose]?,Scheduled/Performed,Char,O,Indicate if this record has happened or is intended to happen.,ECMOOD,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. When implemented, ECMOOD must be populated for all records.",(BRDGMOOD),N/A,"""SCHEDULED"" is for collected subject-level intended dose records. ""PERFORMED"" is for collected subject-level actual dose records. ""Planned"" or ""Scheduled"" can be pre-printed as the CRF name or section header, as applicable. If collecting both the scheduled and performed dosing in the same horizontal record, the sponsor may choose to append ""_SCHEDULED"" to the ECDOSE/ECDOSTXT variable name to delineate the scheduled dose from the performed dose. The performed dose would just be collected with ECDOSE/ECDOSTXT and ECDOSU.",12
Interventions,EC,N/A,N/A,13,ECREFID,Exposure as Collected Reference ID,"An internal or external identifier (e.g., kit number, bottle label, vial identifier).",What is the[study treatment/dose] label identifier?,[Study Treatment] Label Identifier,Char,O,Record treatment label identifier.,ECREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This packaging identifier (e.g., kit number, bottle label, vial identifier) may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some study dosing regimens that require greater granularity for treatment identifiers, sponsors may need to use additional variables.",13
Interventions,EC,N/A,N/A,14,ECLOT,Lot Number,Lot number of the ECTRT product.,What was the lot number of the[study treatment/dose] used?,Lot Number,Char,R/C,Record the lot number that appears on the container holding the study treatment.,ECLOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The lot number identifies the manufacturing batch of the study treatment. In open-label studies, the reference number on the study treatment container may represent an actual lot number and should be submitted using ECLOT. This variable may be populated during the process of creating the SDTM submission datasets. Do not collect other identification variables in this field.",14
Interventions,EC,N/A,N/A,15,ECFAST,Exposure as Collected Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,O,Record whether the subject was fasting prior to the study treatment being taken.,ECFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. Would only be populated when ECMOOD="PERFORMED".,(NY),N/A,"Because some study treatments may have a food effect, it is important to know whether the dose was taken after the subject had fasted.",15
Interventions,EC,N/A,N/A,16,ECDOSFRM,Exposure as Collected Dose Form,The dosage form in which the ECTRT is physically presented.,What was the dose form of the [study treatment/dose]?,Dose Form,Char,R/C,"Record the dose form (e.g., SOLUTION, TABLET, LOTION) or enter the appropriate code from the code list.",ECDOSFRM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FRM),(EXDOSFRM),This must be collected if it cannot be determined from other sources or if there are multiple options for the same study treatment.,16
Interventions,EC,N/A,N/A,17,ECSTDAT,Exposure as Collected Start Date,"The start date of study treatment, intended or actual, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the ([intended/planned/actual]) ([study treatment/dose]) (start) date?,(Start) Date,Char,HR,Record the start date of the study treatment administration using this format (DD-MON-YYYY).,ECSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable ECSTDTC in ISO 8601 format.",N/A,N/A,"Date when constant dosing interval of the study treatment started or single administration occurred. When collecting the date for an individual dose, the word ""start"" may be omitted from the Question Text and Prompt. When ECMOOD is collected and ECMOOD is ""SCHEDULED"", use ""intended"" in the question text and prompt. When ECMOOD is collected and ECMOOD is ""PERFORMED"", use ""actual"" in the question text and prompt.",17
Interventions,EC,N/A,N/A,18,ECSTTIM,Exposure as Collected Start Time,"The start time of study treatment, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the ([intended/planned/actual]) ([study treatment/dose]) (start) time?,(Start) Time,Char,R/C,Record the start time (as complete as possible) when administration of study treatment started.,ECSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable ECSTDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a medication was started only when a protocol or data collection scenarios requires it. When collecting the time for an individual dose, the word ""start"" may be omitted from the question text and prompt.",18
Interventions,EC,N/A,N/A,19,ECENDAT,Exposure as Collected End Date,"The end date of study treatment, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the ([intended/planned/actual]) ([study treatment/dose]) (end) date?,(End) Date,Char,R/C,Record the end date of the study treatment administration using this format (DD-MON-YYYY).,ECENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable ECENDTC in ISO 8601 format.",N/A,N/A,"Date when study treatment period stopped.If start date and end date are not expected to be the same date, the collection of the end date is required. If the study design indicates that the start and end are on the same day, the collection of the end date is not required because it can be assigned to be equal to the start date.",19
Interventions,EC,N/A,N/A,20,ECENTIM,Exposure as Collected End Time,"The end time of study treatment, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the ([intended/planned/actual]) ([study treatment/dose]) (end) time?,(End) Time,Char,R/C,"Record the time, (as complete as possible) when study treatment administration stopped (e.g., for infusions this is the time when the infusion ended).",ECENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable ECENDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a medication was ended when a protocol or data collection scenarios requires it. For infusions, the end time of the infusion is typically needed.",20
Interventions,EC,N/A,N/A,21,ECDSTXT,Exposure as Collected Dose Description,The dose of study medication taken (per administration).,What was the dose (per administration) (of [study treatment/dose])?,Dose,Char,R/C,Record the dose or amount of study treatment that was administered to/taken by the subject in the period recorded; from the start date/time to the end date/time inclusive.,ECDOSTXT; ECDOSE,This does not map directly to an SDTMIG variable. The data collected in this dose text-format field should be mapped to either ECDOSE if numeric or ECDOSTXT if text.,N/A,N/A,"Dose or amount taken for single administration of study treatment or per constant dosing interval recorded. Dose must be collected if it cannot be determined via other methods (e.g., from diary data, drug accountability data, protocol). Care should be taken when mapping ECDSTXT. The data collected in this dose text-format field should be separated or mapped to either ECDOSE if numeric or ECDOSTXT if text.",21
Interventions,EC,N/A,N/A,22,ECDOSU,Exposure as Collected Dose Units,"The unit for intended dose (per administration) for ECDOSE, ECDOSTOT, or ECDOSTXT.",What were the units for the dose?,Units,Char,R/C,"Record the unit of dose or amount taken per period recorded (e.g., ng, mg, mg/kg).",ECDOSU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),(EXDOSU),"Unit of dose or amount taken per constant dosing interval recorded. Dose unit must be collected if it cannot be determined via other methods (e.g., from protocol, randomization data). The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. A CDASH Subset Controlled Terminology Codelist Name is available for dose and volume units. In blinded trials, the collected unit may be tablet, capsule, etc., since the actual unit is also blinded.",22
Interventions,EC,N/A,N/A,23,ECDOSFRQ,EC Dosing Frequency per Interval,The number of doses given/administered/taken during a specific interval.,What was the frequency of [study treatment/dose] dosing?,Frequency,Char,R/C,"Record the frequency the study treatment was administered for a defined period of time (e.g., BID, QID, TID).",ECDOSFRQ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FREQ),(EXDOSFRQ),"This may be collected if it cannot be determined from other sources or if there are multiple options. When possible, the options for dose/amount frequency are pre-printed on the CRF. When collected, the recommendation is to collect dosing information in separate fields (e.g., ECDOSE, ECDOSEU, ECDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.",23
Interventions,EC,N/A,N/A,24,ECROUTE,EC Route of Administration,The route of administration of the study treatment.,What was the route of administration (of the [study treatment/dose])?,Route,Char,R/C,"Record the route of administration (e.g., IV, ORAL, TRANSDERMAL) or enter the appropriate code from the code list.",ECROUTE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ROUTE),(EXROUTE),"This may be collected if it cannot be determined via other methods (e.g., from protocol) or if there are multiple options.",24
Interventions,EC,N/A,N/A,25,ECDOSRGM,Intended Dose Regimen,Text description of the intended schedule or regimen for the Intervention.,What was the intended dose regimen?,Intended Dose Regimen,Char,O,Record the regimen for the study medication.,ECDOSRGM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The regimen information (e.g., TWO WEEKS ON, TWO WEEKS OFF) may further clarify the dose administration and dose frequency. This may be pre-printed or collected. The sponsor may wish to create a codelist to collect this data consistently.",25
Interventions,EC,N/A,N/A,26,ECDOSADJ,Dose Adjusted,An indication of whether the dose was adjusted.,Was the dose adjusted?,(Dose) Adjusted,Char,O,Select either Yes or No to indicate whether there was a change in dosing.,N/A,"When ECADJ is collected, does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED. When ECADJ is not collected, the sponsor may submit this variable in SUPPEC.",(NY),N/A,"Typically, the intent/purpose of collecting this field is to help with data cleaning and monitoring, as it provides a definitive response regarding any dose changes. It provides verification that the associated field on the CRF (ECADJ) was deliberately left blank. However, the sponsor may collect whether the dose was adjusted, without collecting the reason for the change. When using ECMOOD, this field should not be used.",26
Interventions,EC,N/A,N/A,27,ECADJ,Reason for Dose Adjustment,Description of or explanation for why a dose of the study treatment was adjusted.,What was the reason the dose was adjusted?,Reason Adjusted,Char,O,"If there was a change in dosing, record the reason for change.",ECADJ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Captures the reason the dose was changed or modified. The reason may be chosen from a sponsor-defined list (e.g., adverse event, insufficient response) or entered as free text. May be used for variations from protocol-specified doses, or changes from expected doses. Used only when an adjustment is represented in EX dataset.",27
Interventions,EC,N/A,N/A,28,ECITRPYN,EC Exposure Interrupted,An indication of whether the exposure was interrupted.,Was the [(study) treatment/dose] interrupted?,[(Study) Treatment / Dose] Interrupted,Char,O,Record if there was an interruption in the study treatment or dosing.,N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED..,(NY),N/A,"The intent/purpose of collecting this field is to help with data cleaning and monitoring when the actual duration of the exposure is collected using the CDASH field ECCINTD. In some situations, if the actual duration of the interruption is not collected or not derived, this information could be submitted in a SUPPEC.QVAL dataset where SUPPEC.QNAM = ""ECITRPYN"" and SUPPEC.QLABEL = ""Exposure Interrupted"".",28
Interventions,EC,N/A,N/A,29,ECCINTD,EC Interruption Duration,The collected duration of the treatment interruption.,What was the duration of the treatment interruption?,(Interruption) Duration,Char,O,Record the duration of treatment interruption.,SUPPEC.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM="ECITRPD" and SUPPEC.QLABEL= "Interruption Duration". Concatenate the collected treatment interruption duration and the duration unit components and create ECITRPD using ISO 8601 Period format. Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,"This field is used to collect the duration of treatment interruption. In some situations, the duration of the interruption may not be collected but calculated from the treatment start and end times recorded elsewhere in the CRF.",29
Interventions,EC,N/A,N/A,30,ECCINTDU,EC Interruption Duration Units,The unit for the collected duration of treatment interruption.,What was the interruption duration unit?,(Interruption Duration) Unit,Char,O,"Record the unit (e.g., MINUTES, HOURS, DAYS) for the duration of treatment interruption.",SUPPEC.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM = "ECITRPD" and SUPPEC.QLABEL= "Interruption Duration". Concatenate the collected treatment interruption duration and the duration unit components and create ECITRPD using ISO 8601 Period format. Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(UNIT),(EXCINTDU),The unit should be collected as a qualifier to the number for duration.,30
Interventions,EC,N/A,N/A,31,ECLOC,EC Location of Dose Administration,A description of the anatomical location of administration.,What was the anatomical location of the ([study treatment/dose]) administration?,Anatomical Location,Char,O,"Record the body location where the study treatment was administered (e.g., SHOULDER, HIP, ARM).",ECLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location where the study treatment was administered. LAT, DIR, PORTOT are used to further describe the anatomical location.",31
Interventions,EC,N/A,N/A,32,ECLAT,Exposure as Collected Laterality,"Qualifier for anatomical location, further detailing side of the body for the study treatment administration.",What was the side of the anatomical location of the ([study treatment/dose]) administration?,Side,Char,O,"Record the side of the body location where the study treatment was administered (e.g., Left, Right).",ECLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,Further details the laterality of the location where the study treatment was administered. This may be pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,32
Interventions,EC,N/A,N/A,33,ECDIR,Exposure as Collected Directionality,"Qualifier further detailing the position of the anatomical location relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the ([study treatment/dose]) administration?,Directionality,Char,O,"Record the directionality of the body location where the study treatment was administered (e.g., Anterior, Lower, Proximal, Upper).",ECDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,33
Interventions,EC,N/A,N/A,34,ECVAMT,EC Vehicle Amount,The amount of the prepared product (treatment + vehicle) administered or given.,What was the total amount (Drug + Vehicle) (of [study treatment/dose]) administered?,Total Amount (Drug + Vehicle),Num,O,Record the total amount (treatment +vehicle) that was administered/given to the subject.,ECVAMT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTM variable ECTRTV may also be populated during the process of creating the SDTM submission datasets.,N/A,N/A,Administration amount that was given to the subject. \n Note: Should not be the diluent amount alone. The ECTRTV field may be collected if it cannot be determined from other sources.,34
Interventions,EC,N/A,N/A,35,ECVAMTU,EC Vehicle Amount Units,The unit of measurement for the prepared product (treatment + vehicle).,What was the unit for the amount (of [study treatment/dose]) administered?,Unit,Char,O,"Record the unit of total amount (treatment +vehicle) administered/given to the subject (e.g., mL).",ECVAMTU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,Unit of the administration amount,35
Interventions,EC,N/A,N/A,36,ECFLRT,Exposure as Collected Infusion Rate,The flow rate for the total amount of drug + vehicle administered to the subject.,What was the [study treatment/dose] infusion rate?,Infusion Rate,Num,O,"Record the Rate of Infusion (e.g., if rate is 10 mL/min. Record 10 as the infusion rate).",SUPPEC.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM="ECFLRT" and SUPPEC.QLABEL= "Infusion Rate". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,The infusion rate can be used to derive dose.,36
Interventions,EC,N/A,N/A,37,ECFLRTU,Exposure as Collected Infusion Rate Unit,The unit of measure for the flow rate for the total amount of drug + vehicle administered to the subject.,What was the unit for the ([study treatment/dose]) infusion rate?,Infusion Rate Unit,Char,O,"Record the unit for the infusion rate (e.g., mL/min).",SUPPEC.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM="ECFLRTU" and SUPPEC.QLABEL= "Infusion Rate Unit". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(UNIT),(EXFLRTU),Unit of the infusion rate,37
Interventions,EC,N/A,N/A,38,ECTPT,EC Planned Time Point Name,"A text description of the planned time point when measurements should be taken, as defined in the protocol.",What was the planned time point for [study treatment/dose]?,[Planned Time Point Name],Char,R/C,Record the planned time point of study treatment administration if not pre-printed on the CRF.,ECTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. The SDTMIG time-point anchors ECTPTREF (text description) and ECRFTDTC (date/time) may be needed, as well as SDTMIG variables ECTPTNUM, ECELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Planned Time Point can be included as the column heading.",38
Interventions,EC,N/A,N/A,39,ECTRTCMP,Completed Treatment,An indication of whether the subject completed the intended regimen.,Did the subject complete the full course of [study treatment/dose]?,Completed Treatment,Char,O,Select either Yes or No to indicate whether subject has completed the full course of treatment.,SUPPEC.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM = "ECTRTCMP" and SUPPEC.QLABEL ="Completed Treatment". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,"Depending on how the study treatment details are collected on the CRF/eCRF, it may be possible to derive those data if the regimen data are collected.",39
Interventions,EX,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",1
Interventions,EX,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,EX,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Interventions,EX,N/A,N/A,4,EPOCH,Epoch,Name of the trial epoch with which this element of the arm is associated.,What is the trial epoch?,[Epoch](Period/Phase/Sponsor-defined phrase),Char,R/C,[protocol specific],EPOCH,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EPOCH),N/A,"If the same information is collected more than once in different periods/parts of a study (e.g., Disposition), EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as the title of the page. See the SDTMIG for further information regarding EPOCH.",4
Interventions,EX,N/A,N/A,5,EXYN,Any Study Treatment Taken,An indication of whether the subject took study medication/treatment.,Were any[study treatment/dose] taken?,Any Study Treatments,Char,O,"Indicate if the subject took any study medications. If Yes, include the appropriate details where indicated.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank. The EXYN variable is a cleaning or EDC convention meant to indicate that the exposure form should be completed or inserted into the case book.,5
Interventions,EX,N/A,N/A,6,EXCAT,Category of Treatment,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the [study treatment/dose] ?,[Study Treatment Category]; NULL,Char,O,"Record the study treatment category, if not pre-printed on the CRF.",EXCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",6
Interventions,EX,N/A,N/A,7,EXSCAT,Subcategory of Treatment,A sub-division of the EXCAT values based on user-defined characteristics.,What is the subcategory of the [study treatment/dose] ?,[Study Treatment Subcategory]; NULL,Char,O,"Record the study treatment subcategory, if not pre-printed on the CRF.",EXSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. EXSCAT can only be used if there is an EXCAT and it must be a subcategorization of EXCAT.,7
Interventions,EX,N/A,N/A,8,EXTRT,Name of Treatment,Name of the study treatment or intervention given per single administration or during the constant dosing interval for the observation.,What was the [study treatment/investigational product] name?,[Study Treatment/Investigational Product Name],Char,R/C,Record the name of study treatment.,EXTRT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"EXTRT captures the name of the investigational treatment. This is typically collected for open label studies and populated for blinded studies during the SDTM-based dataset creation. Because EXTRT is the SDTMIG topic variable, it is a required variable in SDTM and must have a value in CDASH or a plan to populate it in the SDTM submission datasets (i.e., collected or populated from other sources).",8
Interventions,EX,N/A,N/A,9,EXREFID,Exposure Reference ID,"An internal or external identifier (e.g., kit number, bottle label, vial identifier).",What is the [study treatment/dose] label identifier?,Treatment Label Identifier,Char,R/C,Record treatment label identifier.,EXREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This packaging identifier (e.g., kit number, bottle label, vial identifier) may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some study dosing regimens, greater granularity for treatment identifiers may be needed.",9
Interventions,EX,N/A,N/A,10,EXLOT,Lot Number,Lot number of the EXTRT product.,What was the lot number of the[study treatment/dose] used?,Lot Number,Char,R/C,Record the lot number that appears on the container holding the study treatment.,EXLOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The lot number identifies the manufacturing batch of the study treatment. In open-label studies, the reference number on the study treatment container may represent an actual lot number and is submitted using EXLOT. This variable may be populated during the process of creating the SDTM submission datasets. Do not collect other identification variables in this field.",10
Interventions,EX,N/A,N/A,11,EXFAST,Exposure Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,O,Record whether the subject was fasting prior to the study treatment being taken.,EXFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"Because some study treatments may have a food effect, it is important to know whether the dose was taken after the subject had fasted.",11
Interventions,EX,N/A,N/A,12,EXDOSFRM,Exposure Dose Form,The dosage form in which the EXTRT is physically presented.,What was the dose form of the [study treatment/dose] ?,Dose Form,Char,R/C,"Record the dose form (e.g., SOLUTION, TABLET, LOTION) or enter the appropriate code from the code list.",EXDOSFRM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FRM),(EXDOSFRM),This must be collected if it cannot be determined from other sources or if there are multiple options.,12
Interventions,EX,N/A,N/A,13,EXSTDAT,Exposure Start Date,"The start date of study treatment, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the ([intended/planned/actual]) ([study treatment/dose]) (start) date?,(Start) Date,Char,HR,Record the start date of the study treatment administration using this format (DD-MON-YYYY).,EXSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable EXSTDTC in ISO 8601 format.",N/A,N/A,"Date when the constant dosing interval of the study treatment started or single administration occurred. When collecting the date for an individual dose, the word ""start"" may be omitted from the question text and prompt.",13
Interventions,EX,N/A,N/A,14,EXSTTIM,Exposure Start Time,"The start time of the study treatment, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the ([intended/planned/actual]) ([study treatment/dose]) (start) time?,(Start) Time,Char,R/C,Record the start time (as complete as possible) when administration of study treatment started.,EXSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable EXSTDTC in ISO 8601 format.",N/A,N/A,Recommend collecting the time a medication was started only when a protocol or data collection scenario requires it.,14
Interventions,EX,N/A,N/A,15,EXENDAT,Exposure End Date,"The end date of study treatment, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the ([intended/planned/actual]) ([study treatment/dose]) (end) date?,(End) Date,Char,R/C,Record the end date or last date of administration of study treatment using this format (DD-MON-YYYY).,EXENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable EXENDTC in ISO 8601 format.",N/A,N/A,"If start date and end date are not expected to be on the same date, the end date is required. If the study design indicates that the start and end date are on the same day, the end date is not required because it can be assigned to be equal to the start date.",15
Interventions,EX,N/A,N/A,16,EXENTIM,Exposure End Time,"The end time of treatment, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the ([intended/planned/actual]) ([study treatment/dose]) (end) time?,(End) Time,Char,R/C,"Record the time, (as complete as possible) when study treatment administration stopped (e.g., for infusions this is the time when the infusion ended).",EXENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable EXENDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a medication was ended when a protocol or data collection scenario requires it. For infusions, the end time of the infusion is typically needed.",16
Interventions,EX,N/A,N/A,17,EXDSTXT,Exposure Dose Description,Dose (per administration).,What was the dose [per administration] (of [study treatment/dose]) ?,Dose,Char,R/C,Record the dose or amount of study treatment that was administered to/taken by the subject in the period recorded; from the start date/time to the end date/time inclusive.,EXDOSTXT;EXDOSE,"This does not map directly to an SDTMIG variable. Numeric values map to EXDOSE in SDTM. Non-numeric values (e.g., 200-400) map to EXDOSTXT in SDTM.",N/A,N/A,"Dose or amount taken for single administration of study treatment or per constant dosing interval recorded. Dose must be collected if it cannot be determined via other methods (e.g., from diary data, drug accountability data, protocol). The data collected in this dose text-format field should be mapped to either SDTMIG variable EXDOSE (if numeric) or EXDOSTXT (if text).",17
Interventions,EX,N/A,N/A,18,EXDOSU,Exposure Dose Unit,"The unit for intended dose (per administration) for EXDOSE, EXDOSTOT, or EXDOSTXT.",What was the unit for the dose?,Unit,Char,R/C,"Record the unit of dose or amount taken per period recorded (e.g., ng, mg, mg/kg).",EXDOSU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Unit of dose or amount taken per constant dosing interval recorded. Dose unit must be collected if it cannot be determined via other methods (e.g., from protocol, randomization data). The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. A CDASH Subset Controlled Terminology Codelist Name is available for general dose and volume units.",18
Interventions,EX,N/A,N/A,19,EXDOSFRQ,Exposure Dosing Frequency per Interval,The number of doses given/administered/taken during a specific interval.,What was the frequency of[study treatment/dose] dosing?,Frequency,Char,R/C,Record the frequency the study treatment was administered for a defined period of time.,EXDOSFRQ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FREQ),N/A,"This may be collected if it cannot be determined from other sources or if there are multiple options. When possible, the options for dose/amount frequency are pre-printed on the CRF. When collected, the recommendation is to collect dosing information in separate fields (e.g., ECDOSE, ECDOSEU, ECDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.",19
Interventions,EX,N/A,N/A,20,EXROUTE,Exposure Route of Administration,The route of administration of the study treatment.,What was the route of administration (of the [study treatment/dose] )?,Route,Char,R/C,"Record the route of administration (e.g., IV, ORAL, TRANSDERMAL) or enter the appropriate code from the code list.",EXROUTE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ROUTE),(EXROUTE),"This may be collected if it cannot be determined via other methods (e.g., from protocol) or if there are multiple options.",20
Interventions,EX,N/A,N/A,21,EXDOSRGM,Intended Dose Regimen,The text description of the intended schedule or regimen for the Intervention.,What was the intended dose regimen (of the [study treatment/dose] )?,Intended Dose Regimen,Char,O,Record the regimen for the study medication.,EXDOSRGM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The regimen information may further clarify the dose administration and dose frequency (e.g., TWO WEEKS ON, TWO WEEKS OFF). This may be pre-printed or collected. The sponsor may wish to create a codelist to collect this data consistently.",21
Interventions,EX,N/A,N/A,22,EXDOSADJ,Dose Adjusted,An indication of whether the dose was adjusted.,Was the dose adjusted?,(Dose) Adjusted,Char,O,Select either Yes or No to indicate whether there was a change in dosing.,N/A,"When EXADJ is collected, does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED. When EXADJ is not collected, the sponsor may submit this variable as a SUPPQ.",(NY),N/A,"Typically, the intent/purpose of collecting this field is to help with data cleaning and monitoring, as it provides a definitive response regarding any dose changes. It provides verification that the associate field on the CRF (EXADJ) was deliberately left blank. However, the sponsor may collect whether the dose was adjusted, without collecting the reason for the change.",22
Interventions,EX,N/A,N/A,23,EXADJ,Reason for Dose Adjustment,Description of or explanation for why a dose of the study treatment was adjusted.,What was the reason the dose was adjusted (from planned)?,Reason Adjusted,Char,O,"If there was a change in dosing, record the reason for change.",EXADJ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Captures the reason the dose was changed or modified. The reason may be chosen from a sponsor-defined list (e.g., adverse event, insufficient response) or entered as free text. May be used for variations from protocol-specified doses or changes from expected doses.",23
Interventions,EX,N/A,N/A,24,EXITRPYN,EX Exposure Interrupted,An indication of whether the exposure was interrupted.,Was the [ (study) treatment/dose] interrupted?,[(Study) Treatment / Dose] Interrupted,Char,O,Record if there was an interruption in the study treatment or dosing.,N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,"The intent/purpose of collecting this field is to help with data cleaning and monitoring when the actual duration of the exposure is collected using the CDASH field EXCINTD. In some situations, if the actual duration of the interruption is not collected, or not derived, this information could be submitted in a SUPPEX.QVAL dataset where SUPPEX.QNAM = ""EXITRPYN"" and SUPPEX.QLABEL = ""Exposure Interrupted"".",24
Interventions,EX,N/A,N/A,25,EXCINTD,Exposure Interruption Duration,The collected duration of the treatment interruption.,"If the dose was interrupted, how long was the interruption?",(Interruption) Duration,Char,O,Record the duration of treatment interruption.,SUPPEX.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM="EXITRPD" and SUPPEX.QLABEL= "Interruption Duration". Concatenate the collected treatment interruption duration and the duration unit components and create EXITRPD using ISO 8601 Period format. Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,N/A,N/A,"In some situations, the duration of the interruption may be calculated from the administration start and end times recorded elsewhere in the CRF.",25
Interventions,EX,N/A,N/A,26,EXCINTDU,Exposure Interruption Duration Units,The unit for the collected duration of treatment interruption.,"If the dose was interrupted, what were the units for the interruption duration?",(Interruption Duration) Unit,Char,O,"Record the unit (e.g., MINUTES, HOURS, DAYS) for the duration of treatment interruption.",SUPPEX.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM = "EXITRPD" and SUPPEX.QLABEL= "Interruption Duration". Concatenate the collected treatment interruption duration and the duration unit components and create EXITRPDusing ISO 8601 Period format. Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(UNIT),(EXCINTDU),The unit should be collected and converted into ISO 8601 period format.,26
Interventions,EX,N/A,N/A,27,EXLOC,Exposure Location of Dose Administration,A description of the anatomical location of administration.,What was the anatomical location of the ([study treatment/dose] ) administration?,Anatomical Location,Char,O,"Record the body location where the study treatment was administered (e.g., SHOULDER, HIP, ARM).",EXLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location where the study treatment was administered. LAT, DIR, PORTOT are used to further describe the anatomical location.",27
Interventions,EX,N/A,N/A,28,EXVAMT,Exposure Vehicle Amount,The amount of the prepared product (treatment + vehicle) administered or given.,What was the total amount (Drug + Vehicle)(of [study treatment/dose] ) administered?,Total Amount,Num,O,Record the total amount (treatment +vehicle) that was administered/given to the subject.,EXVAMT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTM variable ECTRTV may also be populated during the process of creating the SDTM submission datasets.,N/A,N/A,Administration amount that was given to the subject. Note: should not be the diluent amount alone. The ECTRTV field may be collected if it cannot be determined from other sources.,28
Interventions,EX,N/A,N/A,29,EXVAMTU,Exposure Vehicle Amount Units,The unit of measure for the prepared product (treatment + vehicle).,What was the unit for the amount (of [study treatment/dose] ) administered?,Unit,Char,O,"Record the unit of total amount (treatment +vehicle) administered/given to the subject (e.g., mL).",EXVAMTU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),(EXVOLTU),Unit of the administration amount. A CDASH Subset Controlled Terminology Codelist Name is available for dose and volume units.,29
Interventions,EX,N/A,N/A,30,EXFLRT,Exposure Infusion Rate,The flow rate for the total amount of drug + vehicle administered to the subject.,What was the [study treatment/dose] infusion rate?,Infusion Rate,Num,O,"Record the Rate of Infusion (e.g., if rate is 10 mL/min. Record 10 as the infusion rate).",SUPPEX.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM = "EXFLRT" and SUPPEX.QLABEL= "Infusion Rate". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,The infusion rate can be used to derive dose.,30
Interventions,EX,N/A,N/A,31,EXFLRTU,Exposure Infusion Rate Unit,The unit of measure for the flow rate for the total amount of drug + vehicle administered to the subject.,What were the units for the [study treatment/dose] infusion rate?,(Infusion Rate) Unit,Char,O,"Record the unit for the infusion rate (e.g., mL/min).",SUPPEX.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM ="EXFLRTU" and SUPPEX.QLABEL="Infusion Rate Unit". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(UNIT),(EXFLRTU),Unit of the infusion rate,31
Interventions,EX,N/A,N/A,32,EXTPT,Exposure Planned Time Point Name,"A text description of the planned time point when measurements should be taken, as defined in the protocol.",What was the planned time point for [study treatment/dose] ?,[Planned Time Point Name],Char,R/C,Record the planned time point of study treatment administration if not pre-printed on the CRF.,EXTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. The SDTMIG time-point anchors EXTPTREF (text description) and EXRFTDTC (date/time) may be needed, as well as SDTMIG variables EXTPTNUM, EXELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",32
Interventions,EX,N/A,N/A,33,EXTRTCMP,Completed Treatment,Indication of whether the subject completed the intended regimen.,Did the subject complete the full course of [study treatment/dose] ?,Completed Treatment,Char,O,Select either Yes or No to indicate whether subject has completed the full course of treatment.,SUPPEX.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM = "EXTRTCMP" and SUPPEX.QLABEL=" Completed Treatment". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,"Depending on how the study treatment details are collected via the CRF/eCRF, it may be possible to derive those data if the regimen data are collected.",33
Interventions,EX,N/A,N/A,34,EXLAT,Exposure Laterality,"Qualifier for anatomical location, further detailing side of the body for the study treatment administration.",What was the side of the anatomical location of the ([study treatment/dose] ) administration?,Side,Char,O,"Record the side of the body location where the study treatment was administered (e.g., Left, Right).",EXLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,Further details the laterality of the location where the study treatment was administered. This may be pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,34
Interventions,EX,N/A,N/A,35,EXDIR,Exposure Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the ([study treatment/dose] ) administration?,Directionality,Char,O,"Record the directionality of the body location where the study treatment was administered (e.g., Anterior, Lower, Proximal, Upper).",EXDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,35
Interventions,PR,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included into the database or created during SDTM-based dataset creation before submission.",1
Interventions,PR,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,PR,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Interventions,PR,N/A,N/A,4,PRYN,Any Procedures Performed,An indication of whether the subject had any procedures performed.,"Were any surgical, therapeutic, or diagnostic procedures performed?",Any Procedures,Char,O,"Indicate if the subject had any surgical, therapeutic or diagnostic procedures. If ""Yes"", include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,4
Interventions,PR,N/A,N/A,5,PRCAT,Procedure Category,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the procedure?,[Procedure Category]; NULL,Char,O,"Record the procedure category, if not pre-printed on the CRF.",PRCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",5
Interventions,PR,N/A,N/A,6,PRSCAT,Procedure Subcategory,A sub-division of the PRCAT values based on user-defined characteristics.,What was the subcategory of the procedure?,[Procedure Subcategory]; NULL,Char,O,"Record the procedure subcategory, if not pre-printed on the CRF.",PRSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and prepopulated in the data management system. This is not typically a question to which the site would provide an answer. PRSCAT can only be used if there is a PRCAT and it must be a subcategorization of PRCAT.,6
Interventions,PR,N/A,N/A,7,PRSPID,Procedure Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.",PRSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile procedure records with medical history and/or with AEs. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",7
Interventions,PR,N/A,N/A,8,PRTRT,Reported Name of Procedure,"The verbatim surgical, therapeutic, or diagnostic procedure's name.",What was the procedure name?,[Procedure Name]; (Specify) Other,Char,HR,Record only one procedure per line.,PRTRT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"In most cases, the verbatim procedure names or therapy will be coded to a standard dictionary (e.g., MedDRA, SNOMED) after the data have been collected on the CRF.",8
Interventions,PR,N/A,N/A,9,PRDECOD,Standardized Procedure Name,"The dictionary or sponsor-defined standardized text description of PRTRT, or the modified topic variable (PRMODIFY), if applicable.",N/A,[Standardized Procedure Name],Char,O,N/A,PRDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(PROCEDUR),N/A,"This is typically not a data collection field that will appear on the CRF. If the sponsor chooses to code the procedure, the sponsor will populate this through the coding process. If PRPRESP is used, and the information about a specific standardized procedure name is being solicited, the data from PRTRT may map directly to the SDTMIG PRDECOD variable.",9
Interventions,PR,N/A,N/A,10,PRMODIFY,Modified Procedure Name,"If the value for PRTRT is modified for coding purposes, then the modified text is placed here.",N/A,N/A,Char,O,N/A,PRMODIFY,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This is not a data collection field that will appear on the CRF. If the sponsor chooses to code the procedure, the sponsor will populate this through the coding process.",10
Interventions,PR,N/A,N/A,11,PRPRESP,Procedure Prespecified,An indication that a specific intervention or a group of interventions is pre-specified on a CRF.,N/A,N/A,Char,O,N/A,PRPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"For pre-specified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both pre-specified and free-text interventions, the value of PRPRESP should be ""Y"" for all prespecified interventions and null for interventions reported as free text.",11
Interventions,PR,N/A,N/A,12,PROCCUR,Procedure Occurrence,An indication of whether a pre-specified procedure (PRTRT) happened when information about the occurrence of a specific intervention is solicited.,Was [PRDECOD/PRTRT] performed?; Has the subject had [PRDECOD/PRTRT]?,[PRDECOD/PRTRT] Performed,Char,O,Indicate if [specific procedure] was performed by checking Yes or No.,PROCCUR,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. If the response was not asked or answered, populate the SDTMIG variable PRSTAT with ""NOT DONE"".",(NY),N/A,PROCCUR is used to report the occurrence of a prespecified procedure or a group of procedures. PROCCUR is not used for spontaneously free text-reported procedures. The site should be able to indicate that the response was not asked or answered.,12
Interventions,PR,N/A,N/A,13,PRREASOC,Procedure Reason for Occur Value,An explanation for why a scheduled procedure did or did not occur.,What was the reason that the procedure was (not) performed?,Reason (Not) Performed,Char,O,Indicate why the procedure was or wasnot performed.,SUPPPR.QVAL,This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM = "PRREASOC" and SUPPPR.QLABEL="Reason for Occur Value". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,N/A,N/A,"The reason the scheduled procedure was or was not performed may be chosen from a sponsor-defined codelist (e.g., SUBJECT REFUSED) or entered as free text. When --REASOC is used, --OCCUR must also be populated in the SDTM dataset with a value of ""Y"" or ""N"".",13
Interventions,PR,N/A,N/A,14,PRREASND,Procedure Reason Not Done,An explanation for why the data are not available.,What was the reason not done?,Reason not done,Char,O,Provide the reason why the procedure was not done.,PRREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The reason the data are not available may be chosen from a sponsor-defined list (e.g., broken equipment, subject refused) or entered as free text. When PRREASND is used, the SDTMIG variable PRSTAT should also be populated in the SDTM-based dataset. The value ""NOT DONE"" here indicates that the subject was not questioned/data was not collected. It does not mean that the subject did not have the procedure.",14
Interventions,PR,N/A,N/A,15,PRPRIOR,Prior Procedure,Indication the procedure occurred prior to [PRSTTPT] or prior to the date in DM.RFSTDTC.,Was the procedure performed prior to [PRSTTPT]?; Was the procedure performed prior to study start?,Prior to [PRSTTPT]; Prior to study,Char,O,Check if the procedure was started before the specified point in time.,PRSTRTPT; PRSTRF,"This does not map directly to an SDTMIG variable. May be used to populate a value into an SDTM relative timing variable such as PRSTRF or PRSTRTPT. When populating PRSTRF, or PRSTRTPT, if the value of the CDASH field PRPRIOR is ""Y"" a value from the CDISC CT (STENRF) may be used. When PRPRIOR refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTM variable PRSTRF should be populated. When PRPRIOR is compared to another time point, the SDTM variables PRSTRTPT and PRSTTPT should be used. Note: PRSTRTPT must refer to the time-point anchor described in PRSTTPT.",(NY),N/A,"See Section 3.7, Mapping Relative Times from Collection to Submissions, and and the SDTMIG for more information about mapping relative times..",15
Interventions,PR,N/A,N/A,16,PRSTDAT,Procedure Start Date,"The date or start date of when the procedure started or was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the procedure (start) date ?,(Start) Date,Char,R/C,Record the date the procedure was started or performed using this format (DD-MON-YYYY). Procedures performed during the study are expected to have a complete start date. Prior procedures that are exclusionary should have both a start and end date.,PRSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable PRSTDTC in ISO 8601 format.",N/A,N/A,"The preferred method is to collect a complete Start Date. Partial dates (e.g., providing year only) for procedures started a considerable amount of time prior to the start of study are acceptable.",16
Interventions,PR,N/A,N/A,17,PRONGO,Ongoing Procedure,Indication the procedure is ongoing when no end date is provided.,Was the procedure ongoing (as of the [study-specific timepoint or period])?,Ongoing (as of the [study-specific timepoint or period]),Char,O,Indicate if the procedure has not ended at the time of data collection and the end date should be left blank.,PRENRTPT; PRENRF,"This does not map directly to an SDTM variable. May be used to populate a value into an SDTMIG relative timing variable such as PRENRF or PRENRTPT. When populating PRENRF, if the value of PRONGO is ""Y"", the value of ""DURING"", ""AFTER"" or ""DURING/AFTER"" may be used. When populating PRENRTPT, if the value of PRONGO is ""Y"", the value of ""ONGOING"" may be used. When PRONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTM variable PRENRF should be populated. When PRONGO is used in conjunction with another time point, the SDTM variables PRENRTPT and PRENTPT should be used. Note: PRENRTPT must refer to a time point anchor described in PRENTPT.",(NY),N/A,"Completed to indicate that the procedure has not stopped at the time point defined by the study. The purpose of collecting this field is to help with data cleaning and monitoring; this field provides further confirmation that the End Date was deliberately left blank. See Section 3.7, Mapping Relative Times from Collection to Submissions, and and SDTMIG for more information about mapping relative times.",17
Interventions,PR,N/A,N/A,18,PRENDAT,Procedure End Date,"The end date of the procedure, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the procedure (end) date?,(End) Date,Char,R/C,"Record the end date of the procedure using this format (DD-MON-YYYY). If the procedure has not ended, leave this field blank and populate PRONGO as ""Y"".",PRENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTM variable PRENDTC in ISO 8601 format.",N/A,N/A,"The assumption is that sponsors should either have an end date or will indicate that the procedure was ongoing at the time of collection or at the end of the study. However, in cases where the end date can be determined from dates collected elsewhere in the CRF it is not necessary to include an end date in the CRF. For example, if the procedure is started and stopped within the same day, the end date will be the same as the start date.",18
Interventions,PR,N/A,N/A,19,PRINDC,Procedure Indication,"The condition, disease, symptom, or disorder that the procedure was used to address or investigate (e.g., why the therapy was taken or administered, why the procedure was performed).",For what indication was the [PRTRT] performed?,Indication,Char,O,"Record the reason the procedure was performed based on clinical investigator's evaluation. If performed to treat a condition, and a diagnosis was made, the indication should be the diagnosis. If performed to treat a condition, and no diagnosis was made, the indication should be the signs and symptoms. If taken as prophylaxis, report as ""Prophylaxis for"" and include a description of the condition(s).",PRINDC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This additional information is collected on the CRF when the sponsor wants to capture the reason(s) why a procedure was performed. This information can then be used as deemed appropriate for coding, analysis (e.g., in the classification of procedures), for reconciling the procedures performed on a subject with their provided medical history, and/or AEs/SAEs as part of the data clean-up and monitoring process.",19
Interventions,PR,N/A,N/A,20,PRAENO,Related Adverse Event ID,Identifier for the adverse event that is the indication for this procedure.,What was the identifier for the adverse event(s) for which the procedure was performed?,Related Adverse Event Identifier,Char,O,Record the identifier of the adverse event for which this procedure was performed.,N/A,"This does not map directly to an SDTMIG variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the AE domain.",N/A,N/A,The intent is to establish a link between the adverse event and the procedure performed for the adverse event. PRAENO can be used to identify a relationship between records in the PR dataset and records in the AE dataset. See the SDTMIG for information on RELREC.,20
Interventions,PR,N/A,N/A,21,PRMHNO,Related Medical History Event ID,Identifier for the medical history event that is the indication for this procedure.,What was the identifier for the medical history event(s) for which the procedure was performed?,Related Medical History Event Identifier,Char,O,Record the identifier of the medical history event for which this procedure was performed.,N/A,"This does not map directly to an SDTMIG variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the MH domain.",N/A,N/A,The intent is to establish a link between the medical history condition and the procedure undergone for the medical history condition. PRMHNO can be used to identify a relationship between records in the PR dataset and records in the MH dataset. See the SDTMIG for information on RELREC.,21
Interventions,PR,N/A,N/A,22,PRDSTXT,Procedure Dose Description,The dose/amount administered during the procedure.,What was the [dose/amount] of [PRTRT] (per administration/for the procedure)?,[Dose/Amount],Char,O,Record the [dose/amount] of [PRTRT] per administered.,PRDOSE; PRDOSTXT,"This does not map directly to an SDTMIG variable. Numeric values map to PRDOSE in SDTM. Non-numeric values (e.g., 200-400) map to PRDOSTXT in SDTM.",N/A,N/A,"Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text or ranges. The data collected in this dose text-format field should be separated or mapped to either SDTMIG PRDOSE if numeric or PRDOSTXT if text.",22
Interventions,PR,N/A,N/A,23,PRDOSU,Procedure Dose Unit,"The unit for intended dose/amount for PRDOSE, PRDOSTOT, or PRDOSTXT.",What was the unit?,Unit,Char,O,Record the unit for the amount of [PRTRT] performed or administered.,PRDOSU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"When sponsors collect data for amount of PRTRT performed or administered, the unit should be collected as well (as applicable).",23
Interventions,PR,N/A,N/A,24,PRDOSFRQ,Procedure Frequency per Interval,The number/amount of the procedure that was given/administered/taken during a specific interval.,What was the frequency of [PRTRT]?,Frequency,Char,O,Record how often the procedure was performed.,PRDOSFRQ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FREQ),N/A,This may be collected if it cannot be determined from other sources or if there are multiple options. Usually expressed as the number of procedures given per a specific interval.,24
Interventions,PR,N/A,N/A,25,PRROUTE,Procedure Route of Administration,The route of administration of the procedure.,What was the route of administration of the procedure?,Route,Char,O,Provide the route of administration for the procedure.,PRROUTE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ROUTE),N/A,This additional information may be important to collect on the CRF when the sponsor would want to capture a procedure's route of administration for comparative analysis purposes.,25
Interventions,PR,N/A,N/A,26,PRLOC,Location of Procedure,"A description of the anatomical location of an procedure (e.g., location of a biopsy).",What was the anatomical location where the procedure was performed?,Anatomical Location,Char,O,Record the body location where the procedure was performed.,PRLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected when the sponsor needs to identify the specific anatomical location (e.g., Liver for the Biopsy). LAT, DIR, PORTOT are used to further describe the anatomical location.",26
Interventions,PR,N/A,N/A,27,PRLAT,Procedure Laterality,"Qualifier for anatomical location, further detailing side of the body for the procedure administration.",What was the side of the anatomical location of the administration?,Side,Char,O,Record the side of the anatomical location where the procedure was administered.,PRLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,Further details the laterality of the location where the procedure was administered/taken. This may be pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,27
Interventions,PR,N/A,N/A,28,PRDIR,Procedure Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the procedure?,Directionality,Char,O,Record the direction of the anatomical location where the procedure was administered.,PRDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,28
Interventions,PR,N/A,N/A,29,PRPORTOT,Procedure Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of).",What was the portion or totality of the anatomical location that was treated?,Portion or Totality,Char,O,Record the portion of the body location that was treated.,PRPORTOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(PORTOT),N/A,Collected when the sponsor needs to identify the specific portionality for the anatomical locations. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,29
Interventions,PR,N/A,N/A,30,PRFAST,Procedure Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,O,Record whether the subject was fasting prior to the procedure being performed.,PRFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,This information is collected when the procedure may be affected by whether the subject was fasting. This may not be relevant for all procedures.,30
Interventions,PR,N/A,N/A,31,PRDOSRGM,Procedure Intended Dose Regimen,The text description of the (intended) schedule or regimen for the procedure.,What was the intended procedure regimen?,Intended Procedure Regimen,Char,O,Record the intended regimen for the procedure to be performed.,PRDOSRGM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The regimen information may further clarify the dose administration and dose frequency (e.g., TWO WEEKS ON, TWO WEEKS OFF). This may be prespecified or collected. The sponsor may wish to create a codelist to collect this data consistently.",31
Interventions,PR,N/A,N/A,32,PRDOSADJ,Procedure Adjusted,An indication of whether the procedure dose/amount was adjusted.,Was the procedure dose adjusted?,(Dose) Adjusted,Char,O,Record if the procedure was adjusted from planned.,N/A,"When PRADJ is collected, does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED. When PRADJ is not collected, the sponsor may submit this variable as a SUPPQ.",(NY),N/A,"Typically, the intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the associate field on the CRF (PRADJ) was deliberately left blank. However, the sponsor may collect whether the procedure dose/amount was adjusted, without collecting the reason for the change.",32
Interventions,PR,N/A,N/A,33,PRADJ,Reason for Procedure Adjustment,Description of or explanation for why a procedure dose/amount was adjusted.,What was the reason the procedure dose was adjusted?,Reason Adjusted,Char,O,Record why the procedure dose was adjusted from planned.,PRADJ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Captures the reason the PRTRT dose was changed or modified. The reason may be chosen from a sponsor-defined list (e.g., adverse event, insufficient response) or entered as free text.",33
Interventions,PR,N/A,N/A,34,PRTRTCMP,Completed Procedure,Indication of whether the subject completed the intended regimen.,Did the subject complete the full course of the [PRTRT]?,Completed [PR Intervention Topic],Char,O,Record if the subject completed the intended regimen.,SUPPPR.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM= "PRTRTCMP" and SUPPPR.QLABEL="Treatment Completed". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,"Depending on how the PTTRT dose details are collected via the CRF/eCRF, it may be possible to derive those data if the regimen data are collected.",34
Interventions,PR,N/A,N/A,35,PRITRPYN,Procedure Interrupted,An indication of whether the procedure was interrupted.,Was the procedure interrupted?,Procedure Interrupted,Char,O,Record if the procedure was interrupted.,N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,"Provides a definitive response regarding any procedure interruption. The intent/purpose of collecting this field is to help with data cleaning and monitoring when the duration of the interruption is collected. In some situations, if the actual duration of the interruption is not collected, or not derived, this information could be submitted in a SUPPPR dataset.",35
Interventions,PR,N/A,N/A,36,PRITRPRS,Reason Procedure Interrupted,An explanation for why the intervention was interrupted.,Why was the procedure interrupted?,Reason Procedure Interrupted,Char,O,Record the reason the procedure was interrupted.,SUPPPR.QVAL,This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM="PRITRPRS" and SUPPPR.QLABEL ="Reason Intervention Interrupted". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,This CDASH field is use to collected the reason why an intervention was interrupted. The sponsor may define controlled terminology.,36
Interventions,PR,N/A,N/A,37,PRCINTD,Procedure Interruption Duration,The collected duration of the procedure interruption.,What was the duration of the procedure interruption?,(Interruption) Duration,Char,O,Record how long the procedure was interrupted before it resumed.,SUPPPR.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM="PRITRPD" and SUPPPR.QLABEL= "Interruption Duration". Concatenate the collected procedure interruption duration and the duration unit components and create PRITRPD using ISO 8601 Period format. Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,"This field is used to collect the duration of procedure interruption. In some situations, the duration of the interruption may not be collected but calculated from the procedure start and end times recorded elsewhere in the CRF.",37
Interventions,PR,N/A,N/A,38,PRCINTDU,Procedure Interruption Duration Units,The unit for the collected duration of the procedure interruption.,What was the interruption duration unit?,(Interruption Duration) Unit,Char,O,Record the unit for the duration of interruption of the procedure.,SUPPPR.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM="PRITRPD" and SUPPPR.QLABEL= "Interruption Duration". Concatenate the collected procedure interruption duration and the duration unit components and create PRITRPD using ISO 8601 Period format. Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(UNIT),N/A,The unit should be collected as a qualifier to the number for duration.,38
Interventions,PR,N/A,N/A,39,PRLLT,Procedure Lowest Level Term,The dictionary-derived text description of the lowest level term.,N/A,N/A,Char,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM="PRLLT" and SUPPPR.QLABEL="Lower Level Term". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,"This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for coding. Another dictionary can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",39
Interventions,PR,N/A,N/A,40,PRLLTCD,Procedure Lowest Level Term Code,The dictionary-derived code for the lowest level term.,N/A,N/A,Num,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM="PRLLTCD" and SUPPPR.QLABEL="Lower Level Term Code". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,"This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for MedDRA coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",40
Interventions,PR,N/A,N/A,41,PRPTCD,Procedure Preferred Term Code,The dictionary-derived code for the preferred term.,N/A,N/A,Num,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR.QVAL dataset where SUPPPR.QNAM="PRPTCD" and SUPPPR.QLABEL= "Preferred Term Code Lower Level Term Code". Refer to the current SDTM and SDTMIG for instructions on placement of NSVsin SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,"This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for MedDRA coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",41
Interventions,PR,N/A,N/A,42,PRHLT,Procedure High Level Term,The dictionary-derived text description of the high level term for the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM="PRHLT" and SUPPPR.QLABEL="High Level Term". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,"This is not a data collection field that would appear on the CRF. Sponsors populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for MedDRA coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",42
Interventions,PR,N/A,N/A,43,PRHLTCD,Procedure High Level Term Code,The dictionary-derived code for the high level term for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR.QVAL dataset where SUPPPR.QNAM="PRHLTCD" and SUPPPR.QLABEL="High Level Term Code". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,"This is not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for MedDRA coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",43
Interventions,PR,N/A,N/A,44,PRHLGT,Procedure High Level Group Term,The dictionary-derived text description of the high level group term for the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM="PRHLTGT" and SUPPPR.QLABEL="High Level Group Term". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,"This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for MedDRA coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",44
Interventions,PR,N/A,N/A,45,PRHLGTCD,Procedure High Level Group Term Code,The dictionary-derived code for the high level group term for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM= "PRHLTGTCD" and SUPPPR.QLABEL="High Level Group Term Code". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,"This is not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for MedDRA coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",45
Interventions,PR,N/A,N/A,46,PRSOC,PR Primary System Organ Class,The dictionary-derived text description of the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR.QVAL dataset where SUPPPR.QNAM="PRSOC" and SUPPPR.QLABEL="Primary System Organ Class". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,"This is not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for MedDRA coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",46
Interventions,PR,N/A,N/A,47,PRSOCCD,PR Primary System Organ Class Code,The dictionary-derived code for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,SUPPPR.QVAL,This information could be submitted in a SUPPPR dataset as the value of SUPPPR.QVAL where SUPPPR.QNAM= "PRSOCCD" and SUPPPR.QLABEL="Primary System Organ Class Code". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains. Sponsors should include an Origin column in the SUPPQ dataset to indicate that the data was "ASSIGNED".,N/A,N/A,"This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Rationale for adding coding variables to CDASH is to provide a more complete data management package. This variable could be used in the PR domain for MedDRA coding. Other dictionaries can be used and the appropriate coding elements added, if appropriate, in the SUPPPR.QVAL dataset.",47
Interventions,SU,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",1
Interventions,SU,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,SU,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Interventions,SU,N/A,N/A,4,SUTRT,Reported Name of Substance,"The type of substance (e.g., TOBACCO, ALCOHOL, CAFFEINE or CIGARETTES, CIGARS, COFFEE).",What [is/was] the [name/type] of (the) substance used?,[Type of Substance],Char,HR,N/A,SUTRT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsors may require different types of substance-use data (e.g., illicit drug use, cigarettes); the value for category may be pre-printed on the CRF as a label for the prompt for Substance Use. If a more detailed type of substance appears on the CRF (e.g., CIGARETTES, CIGARS rather than TOBACCO), SUCAT should be TOBACCO and SUTRT should be CIGARETTES.",4
Interventions,SU,N/A,N/A,5,SUCAT,Category for Substance Use,A grouping of topic-variable values based on user-defined characteristics.,What is/was the category of the substance (used)?,[Substance (Used) Category]; NULL,Char,R/C,"Record the Substance Used category, if not pre-printed on the CRF.",SUCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology (e.g., TOBACCO, ALCOHOL, CAFFEINE). Sponsors may require different types of substance-use data (e.g., illicit drug use, cigarettes); the value for category may be pre-printed on the CRF. If a more detailed type of substance appears on the CRF (e.g., CIGARETTES, CIGARS, rather than TOBACCO), SUCAT is TOBACCO and SUTRT is CIGARETTES. If the sponsor does not specify a type of tobacco on the CRF, SUTRT is TOBACCO. If SUCAT is not collected (e.g., it is evident from the protocol design), it could be populated during the SDTM-based dataset creation process.",5
Interventions,SU,N/A,N/A,6,SUSCAT,Subcategory for Substance Use,A sub-division of the SUCAT values based on user-defined characteristics.,What was the subcategory of the substance (used)?,[Substance (Used) Subcategory]; NULL,Char,O,"Record the Substance Use subcategory, if not pre-printed on the CRF.",SUSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. The value for subcategory may be pre-printed on the CRF or hidden. SUSCAT can only be used if there is a SUCAT and it must be a subcategorization of SUCAT.,6
Interventions,SU,N/A,N/A,7,SUPRESP,SU Prespecified,An indication that a specific intervention or a group of interventions is prespecified on a CRF.,N/A,N/A,Char,O,N/A,SUPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"For pre-specified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both pre-specified and free-text interventions, the value of SUPRESP should be ""Y"" for all prespecified interventions and null for interventions reported as free text.",7
Interventions,SU,N/A,N/A,8,SUYN,Any Substance Used,An indication of whether any data was collected for the intervention topic.,Were any [sponsor-phrase/substance name/recreational drugs] used?,Any [Substance Name (Used)],Char,O,Indicate if the subject had used any (sponsor-defined phrase/recreational drugs/alcohol/substance name).,N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,General prompt question to aid in monitoring and data cleaning. This provides verification that all other fields on the CRF were deliberately left blank. This is a field that can be used on any Interventions CRF to indicate whether there is data to record.,8
Interventions,SU,N/A,N/A,9,SUNCF,Never Current Former Usage,Indication the pre-specified substance was used.,Has the subject ever [used/consumed] [SUTRT/SUCAT]?,([Substance]) Usage,Char,R/C,"Check the appropriate box to indicate if the subject has ever used/consumed tobacco/alcohol/caffeine, currently consumes tobacco/alcohol/caffeine, or formerly used/consumed tobacco/alcohol/caffeine.",SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF; SUPPSU.QVAL,This does not map directly to an SDTMIG variable. May be used to populate SUOCCUR and relative timing variables.,(NCF),(SUNCF),"The 3 options (NEVER, CURRENT, FORMER) are sponsor-defined in relation to the protocol. If the sponsor has specific definitions, these definitions are detailed in the instructions to the site. As this type of response does not correspond exactly to an SDTM variable, CDASH recommends using the CDASHIG variable SUNCF. Sponsors must decide how to populate the appropriate relative timing variables when creating the SDTM-based datasets. For example, If SUNCF =""Never"", the value of SUOCCUR will be ""N"" and all relative timing variables will be null. If the sponsor chooses to populate the relative start references (SUSTRTPT, SUSTRF) the value will be ""BEFORE"" when SUNCF= ""CURRENT"" and ""FORMER"". If the sponsor also chooses to use relative end references (SUENRF, SUENRTPT) , the SUENRTPT value will be ""ONGOING"" when SUNCF=""CURREN"" while the value of SUENRF will be ""DURING/AFTER"". \n Note: When using SUSTRTPT and/or SUENRTPT, these must refer to a time-point anchor (e.g., SCREENING, in SUSTTPT/SUENTPT).",9
Interventions,SU,N/A,N/A,10,SUSPID,Substance Use Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.",SUSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",10
Interventions,SU,N/A,N/A,11,SUREASND,Reason Substance Use Not Collected,An explanation for why data are not available.,What was the reason the data was not collected?,Reason Not Collected,Char,O,Provide the reason why the substance used data were not collected.,SUREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The reason data are not available may be chosen from a sponsor-defined list (e.g., subject refused) or entered as free text. When PRREASND is used, the SDTMIG variable PRSTAT should also be populated in the SDTM-based dataset.",11
Interventions,SU,N/A,N/A,12,SUDSTXT,Substance Dose Description,"The amount of substance used (e.g., 1-2 packs, 8 oz).",What is/was the amount of [SUTRT] used/consumed?,Amount,Char,O,Check the appropriate box to indicate the amount of tobacco/alcohol/caffeine the subject consumes on a regular basis.,SUDOSE; SUDOSU; SUDOSTXT,"This does not map directly to an SDTMIG variable. Numeric values map to SUDOSE in SDTM. Non-numeric values (e.g., 200-400) map to SUDOSTXT in SDTM.",N/A,N/A,"Where possible, the options for dose/amount are pre-printed on the CRF. In the example given in the definition, ""packs"" and ""ounces"" are included as a point of reference. They would, of course, be submitted as SUDOSU. Care should be taken to map each record to the appropriate SDTM variable SUDOSTXT (text results that cannot be represented in a numeric field) and SUDOSE (numeric results).",12
Interventions,SU,N/A,N/A,13,SUDOSFRQ,Substance Use Frequency per Interval,The number/amount of the of substance consumed per a specific interval.,What [is/was] the frequency of [SUTRT] [use/consumption]?,Frequency,Char,O,Record how often the subject regularly [uses / consumes] (the) [substance].,SUDOSFRQ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FREQ),N/A,"When possible, the options for dose/amount frequency are pre-printed on the CRF. (e.g., PER DAY, PER WEEK, OCCASIONAL).",13
Interventions,SU,N/A,N/A,14,SUSTDAT,Substance Use Start Date,"The date substance use started, represented in an unambiguous date format (e.g., DD-MON-YYYY.",What was the start date of [SUTRT/SUCAT] use/consumption?,Start Date,Char,O,Record the start date of the substance use using this format (DD-MON-YYYY).,SUSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable SUSTDTC in ISO 8601 format.",N/A,N/A,"The sponsor may choose to capture a complete date or any variation thereof (e.g., month and year, year).",14
Interventions,SU,N/A,N/A,15,SUENDAT,Substance Use End Date,"The date substance use ended, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the end date of [SUTRT/SUCAT] use/consumption?,End Date,Char,O,Record the end date of the substance use using this format (DD-MON-YYYY).,SUENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable SUENDTC in ISO 8601 format.",N/A,N/A,"The sponsor may choose to capture a complete date or any variation thereof (e.g., month and year, year).",15
Interventions,SU,N/A,N/A,16,SUCDUR,Substance Use Collected Duration,Collected duration of the substance use.,What was the duration of [SUTRT/SUCAT] use/consumption?,Duration,Char,O,"Provide the duration of the substance use (e.g., Record how long the subject has smoked).",SUDUR,"This does not map directly to an SDTMIG variable. For the SDTM-based dataset, concatenating the CDASH collected duration and collected duration unit and populate the SDTMIG variable SUDUR in ISO 8601 format. Example: P1DT2H (for 1 day, 2 hours).",N/A,N/A,This is only collected on the CRF if this level of detail is needed and if SUSTDAT and SUENDAT are not collected on the CRF.,16
Interventions,SU,N/A,N/A,17,SUCDURU,Substance Use Collected Duration Unit,Unit of the collected duration of the substance use. Used only if duration was collected on the CRF.,What was the unit of duration of [SUTRT/SUCAT] use/consumption?,(Duration) Unit,Char,O,Select the appropriate duration unit of the substance use.,SUDUR,"This does not map directly to an SDTMIG variable. For the SDTM-based dataset, concatenating the CDASH collected duration and collected duration unit and populate the SDTMIG variable SUDUR in ISO 8601 format. Example: P1DT2H (for 1 day, 2 hours).",(UNIT),N/A,Sponsor-defined options should be pre-printed on the CRF to avoid making this a free-text field. This will allow the response to be translated into ISO 8601 format.,17
Interventions,SU,N/A,N/A,18,SUMODIFY,Modified Substance Name,"If the value for SUTERM is modified for coding purposes, then the modified text is placed here.",N/A,N/A,Char,O,N/A,SUMODIFY,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This is not a data collection field that would appear on the CRF. If the sponsor chooses to code the substance use, the sponsor will populate this through the coding process.",18
Interventions,SU,N/A,N/A,19,SUDECOD,Standardized Substance Name,"The dictionary or sponsor-defined standardized text description of SUTRT, or the modified topic variable (SUMODIFY), if applicable.",N/A,N/A,Char,O,N/A,SUDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata to indicate that the data was "ASSIGNED".,N/A,N/A,"This is typically not a data collection field that will appear on the CRF. If the sponsor chooses to code the substance use, the sponsor will populate this through the coding process. Equivalent to the generic drug name in published (e.g., WHODrug, SNOMED, ICD9) or sponsor-defined dictionaries. If SUPRESP is used, and the information about a specific standardized substance name is being solicited, the data from SUTRT may map directly to the SDTMIG SUDECOD variable.",19
Interventions,ML,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",1
Interventions,ML,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on CRFs that are shipped to each site. \n EDC: This should be prepopulated.",2
Interventions,ML,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Interventions,ML,N/A,N/A,4,MLCAT,Category for Meal,A grouping of topic-variable values based on user-defined characteristics.,What is the category for the [meal/food product]?,[Meal/Food Product] Category]; NULL,Char,O,"Record the [meal/food product] category, if not pre-printed on the CRF.",MLCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a pre-printed category value on the CRF and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",4
Interventions,ML,N/A,N/A,5,MLSCAT,Subcategory for Meal,A sub-division of the MLCAT values based on user-defined characteristics.,What is the subcategory for the [meal/food product]?,[Meal/Food Product] Subcategory]; NULL,Char,O,"Record the [meal/food product] subcategory, if not pre-printed on the CRF.",MLSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and prepopulated in the data management system. This is not typically a question to which the site would provide an answer.,5
Interventions,ML,N/A,N/A,6,MLYN,Any Meal Taken,An indication of whether any meal or food product were consumed or administered. \n \n \n,[Were/Was] any [meal/food product] [taken/consumed/administered] ?,Any [meal/food product] [taken/consumed/administered] ?,Char,O,"Indicate if the subject consumed any [meal/food product]. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,6
Interventions,ML,N/A,N/A,7,MLSPID,ML Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",MLSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile meal/food product records with AEs and/or MH. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",7
Interventions,ML,N/A,N/A,8,MLTRT,Name of Meal or Food Product,"The reported name of the food, beverage or combination of food or beverage consumed at one time. \n",What was the [meal/food product/sponsor-defined] (name)?,[Meal],Char,HR,Record only 1 [meal/food product name] per line.,MLTRT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsors may use the name of a food or the name of the combination of foods (e.g., breakfast, low-fat meal, breakfast bar, water). \n",8
Interventions,ML,N/A,N/A,9,MLPRESP,ML Pre-specified,An indication that a specific intervention or a group of interventions is pre-specified on a CRF.,N/A,N/A,Char,O,N/A,MLPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"For pre-specified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both pre-specified and free-text interventions, the value of MLPRESP should be ""Y"" for all pre-specified interventions and null for interventions reported as free text.",9
Interventions,ML,N/A,N/A,10,MLOCCUR,ML Occurrence,An indication of whether the pre-specified meal or food product were taken/consumed/administered when information about the occurrence of the specific intervention was solicited.,Did the subject take [MLTRT]?; Has the subject [taken/consumed/administered] [MLTRT]?,[MLTRT],Char,O,Indicate if [MLTRT] was [taken/consumed/administered] by checking Yes or No.,MLOCCUR,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. If the question was not asked or answered, populate the SDTMIG variable MLSTAT with ""NOT DONE"".",(NY),N/A,MLOCCUR is used to report the occurrence of a pre-specific meal/ food product. MLOCCUR is not used for spontaneously reported free-text meals/food products. The site should be able to indicate that the response was not asked or answered.,10
Interventions,ML,N/A,N/A,11,MLREASOC,Reason for Occur Value,An explanation for why the scheduled intervention did or did not occur.,What was the reason that the [MLTRT] was (not) consumed/taken/done/administered]?,Reason for Occur Value,Char,O,Reason [MLTRT] (Not) [Performed/Taken/Done/Administered],SUPP--.QVAL,This information could be submitted in a SUPPML dataset as the value of SUPPML.QVAL where SUPPML.QNAM = "MLREASOC" and SUPPML.QLABEL ="Reason for Occur Value". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,N/A,N/A,"The reason MLTRT occurred may be chosen from a sponsor-defined codelist or entered as free text. When --REASOC is used, --OCCUR must also be populated in the SDTM dataset. This variable should not be used to represent that the item was ""NOT ANSWERED "", ""NOT DONE."" ""NOT COMPLETED"" or ""UNKNOWN"". The variables MLSTAT /MLREASND should be used instead.",11
Interventions,ML,N/A,N/A,12,MLREAS,ML Reason,The reason that the meal/food product was used.,What was the reason for the [meal/food product] [[taken/consumed/administered]?,Reason,Char,O,Record the reason the meal/product was taken.,MLREAS,This information could be submitted in a SUPPML dataset as the value of SUPPML.QVAL where SUPPML.QNAM = "MLREAS" and SUPPML.QLABEL ="Reason for the Intervention". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,"This is the condition, disease, symptom, or disorder for which the meal or food product is taken/consumed/administered This additional information is collected on the CRF when sponsors want to capture the reason(s) why a subject took a meal/product.",12
Interventions,ML,N/A,N/A,13,MLCENO,Related Clinical Event ID,Identifier for the clinical event event that is the indication for this meal or food product.,What was the identifier for the clinical event s) for which the (meal/food product] was [taken/consumed/administered],Clinical Event Identifier,Char,O,Record the identifier of the Clinical Event for which this [meal/food product] was taken/consumed/administered.,N/A,"This does not map directly to an SDTMIG variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the CE domain.",N/A,N/A,The intent is to establish a link between the meal/food product and a clinical event that was reported. MLCENO can be used to identify a relationship between records in ML dataset and records in the CE dataset. See the SD for information on RELREC.,13
Interventions,ML,N/A,N/A,14,MLDOSE,Dose,"The quantity/amount of the meal or food product (e.g., --TRT) taken/consumed/administered represented as a numeric value.",What was the quantity/amount (of the) ([meal/food product]) [taken/consumed/administered]?,[Quantity/Amount] (given at one time),Num,O,"Record the quantity/amount of the meal/food product (e.g., --TRT ) given at one time represented as a numeric value.",MLDOSE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Used when the quantity taken/administered/consumed has only numeric entries. If non-numeric entries are possible, use the CDASH field MLDSTXT.",14
Interventions,ML,N/A,N/A,15,MLDSTXT,Dose Description,"The quantity/amount of the meal or food product (e.g., --TRT) taken/consumed/administered represented as a numeric or text value.",What was quantity/amount (of the) ([meal/food product]) [taken/consumed/administered]?,Dose,Char,O,Record the quantity/amount of the [meal/food product] taken/consumed/administered at one time.,MLDOSTXT; MLDOSE,"This does not map directly to an SDTMIG variable. Numeric values map to MLDOSE in SDTM. Non-numeric values (e.g., 200-400) map to MLDOSTXT in SDTM.",N/A,N/A,"Defining this data collection field as a text field allows for flexibility in capturing entries as numbers, text, or ranges. The data collected in this text-format field should be separated or mapped to either SDTMIG MLDOSE (if numeric) or MLDOSTXT (if text).",15
Interventions,ML,N/A,N/A,16,MLDOSU,Dose Units,The unit associated with the quantity/amount of the the meal /food product taken/consumed/administered.,What is the unit for the quantity/amount of the [meal/food product]?,(Quantity/Amount) Unit,Char,R/C,Record the unit for the quantity/amount of the [meal/food product] taken/consumed/administered.,MLDOSU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),(CMDOSU),"When sponsors collect data for amount /quantity of meal/food product taken (i.e., Dose, Total Daily Dose), the unit must be collected as well (if applicable).",16
Interventions,ML,N/A,N/A,17,MLSTDAT,Meal Start Date,"The start date when the meal or food product was first taken/consumed/administered, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date the [meal/food product] was first [taken/consumed/administered]?,(Start) Date,Char,R/C,Record the date the [meal/food product] was first taken/consumed/administered using this format (DD-MON-YYYY).,MLSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable MLSTDTC in ISO 8601 format.",N/A,N/A,"The assumption is that sponsors should either have a start date or will indicate that the meal or food product was started before, during, or after the study period. The preferred method is to collect a complete start date. Partial dates (e.g., providing year only) for meal/food product started a considerable amount of time prior to the start of study are acceptable.",17
Interventions,ML,N/A,N/A,18,MLSTTIM,Meal Start Time,"The time the meal or food product was started, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [meal/food product] start time?,Start Time,Char,R/C,Record the time (as complete as possible) that the [meal/food product] was started.,MLSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable MLSTDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a meal/food product was started only when a protocol or data collection scenarios supports it. Typically, a start time is not collected unless the subject is under the direct care of the site at the time a meal/food product or the subject records the start time in a diary. See Section 3.7, Mapping Relative Times from Collection to Submissions, and the SDTMIG for more information.",18
Interventions,ML,N/A,N/A,19,MLENDAT,Meal End Date,"The date that the subject ended/stopped taking/consuming/administering the meal or food product product represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the [meal/food product] end date?,End Date,Char,R/C,Record the date the [meal/food product] was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the [meal/product] leave this field blank.,MLENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable MLENDTC in ISO 8601 format.",N/A,N/A,"The assumption is that sponsors should either have an end date or will indicate that the meal or food product was ongoing at the time of collection or at the end of the study. However, in cases where the end date can be determined from dates collected elsewhere in the CRF it is not necessary to include an end date in the CRF.",19
Interventions,ML,N/A,N/A,20,MLENTIM,Meal End Time,"The time when the subject ended/stopped taking the meal or food product represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [meal/food product] end time?,End Time,Char,R/C,Record the time (as complete as possible) that the [meal/food product] was stopped.,MLENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable MLENDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a meal/food product was ended only when a protocol or data collection scenarios require it or the subject records the start time in a diary. Typically, a end time is not collected unless the subject is under the direct care of the site at the time a meal/food product or the subject records the end time in a diary. See Section 3.7, Mapping Relative Times from Collection to Submissions, and the SDTMIG for more information.",20
Interventions,ML,N/A,N/A,21,MLDECOD,Standardized Meal Name,"The dictionary or sponsor-defined standardized text description of the topic variable (MLTRT) or the modified topic variable (MLMODIFY), if applicable.",N/A,N/A,Char,O,N/A,MLDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. Equivalent to a standardized name in a published or sponsor-defined dictionaries.,21
Interventions,ML,N/A,N/A,22,MLMODIFY,Modified Reported Term,"If the value for MLTRT is modified for coding purposes, then the modified text is placed here.",N/A,N/A,Char,O,N/A,MLMODIFY,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This is not a data collection field that will appear on the CRF itself. Sponsors will populate this through the coding process.,22
Interventions,AG,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",1
Interventions,AG,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on CRFs that are shipped to each site. EDC: This should be pre-populated.",2
Interventions,AG,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTM DM domain. For more information, refer to the SDTMIG.",3
Interventions,AG,N/A,N/A,4,AGCAT,Category for Agent,A grouping of topic-variable values based on user-defined characteristics.,What is the category for the [procedure/assessment agent]?,Procedure Agent Category; NULL,Char,O,"Record the procedure agent category, if not pre-printed on the CRF.",AGCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",4
Interventions,AG,N/A,N/A,5,AGSCAT,Subcategory for Agent,A sub-division of the AGCAT values based on user-defined characteristics.,What is the subcategory for the [procedure/assessment agent]?,Procedure Agent Subcategory; NULL,Char,O,"Record the procedure agent subcategory, if not pre-printed on the CRF.",AGSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer.,5
Interventions,AG,N/A,N/A,6,AGYN,Any Procedure Agent Taken,An indication of whether any procedure/assessment agent(s) were administered.,[Were/Was] there any [procedure/assessment agent(s)] taken/administered?,Any procedure agents,Char,O,"Indicate if the subject was administered any procedure agents. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,6
Interventions,AG,N/A,N/A,7,AGSPID,AG Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor defined question],[Sponsor defined],Char,O,"If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.",AGSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile procedure agent records with AEs and/or MH. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",7
Interventions,AG,N/A,N/A,8,AGTRT,Reported Agent Name,Verbatim name of procedure/assessment agent administered.,What was the [procedure/assessment agent] [name/term]?,[Procedure/Assessment Agent],Char,HR,Record only 1 procedure agent per line. Provide the full trade or proprietary name of the procedure agent; otherwise the generic name may be recorded.,AGTRT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"In most cases, the verbatim drug names or treatment will be coded to a standard dictionary (e.g., WHODrug) after the data have been collected on the CRF. For the collection of verbatim procedure agents, the recommendation is to ask sites to provide the full trade or proprietary name since it is more exact than the generic. The full trade name provides the base generic and the appropriate salt for that particular drug. In addition, for coding purposes it helps with Anatomical Therapeutic Chemical (ATC) classification system code selection. For example, Tylenol with codeine #1 has a different ATC code than Tylenol with codeine #3.",8
Interventions,AG,N/A,N/A,9,AGPRESP,AG Pre-Specified,An indication that a specific procedure/assessment agent or group of agents is pre-specified on a CRF.,N/A,N/A,Char,O,N/A,AGPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"For pre-specified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both pre-specified and free-text interventions, the value of AGPRESP should be ""Y"" for all prespecified interventions and null for interventions reported as free text.",9
Interventions,AG,N/A,N/A,10,AGOCCUR,AG Occurrence,An indication whether the given procedure/assessment agent or group of agents was administered when information about the occurrence of a specific procedure/assessment agent is solicited.,[Has/Was] the subject (been) administered the [procedure/assessment agent]?,[AGTRT],Char,O,"Indicate if the procedure agent was administered, by checking Yes or No.",AGOCCUR,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. If the response was not asked or answered, populate the SDTMIG variable AGSTAT with ""NOT DONE"".",(NY),N/A,AGOCCUR is used to report the occurrence of a pre-specified procedure agent. AGOCCUR is not used for spontaneously free-text reported procedure agent(s). The site should be able to indicate that the response was not asked or answered.,10
Interventions,AG,N/A,N/A,11,AGDOSE,AG Dose per Administration,"The dose of procedure/assessment agent (e.g., --TRT ) given at one time represented as a numeric value.",What was the individual dose per administration of the [procedure/assessment agent]?,[Dose/Amount] (per administration),Num,O,"Record the dose of the [procedure agent] taken per administration (e.g., 200).",AGDOSE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Used when the dose/amount administered has only numeric entries. If non-numeric entries are possible, use the CDASH field AGDSTXT.",11
Interventions,AG,N/A,N/A,12,AGDSTXT,Procedure Agents Dose Description,The dose of procedure/assessment agent administered per instance.,What was the individual dose of the [procedure/assessment agent]?,Dose,Char,O,"Record the dose of [procedure agent] taken per administration (e.g., 200).",AGDOSE; AGDOSTXT,"This does not map directly to an SDTMIG variable. Numeric values map to AGDOSE in SDTM. Non-numeric values (e.g., 200-400) map to AGDOSTXT in SDTM.",N/A,N/A,"Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text or ranges. The data collected in this dose text-format field should be separated or mapped to either SDTMIG AGDOSE (if numeric) or AGDOSTXT (if text).",12
Interventions,AG,N/A,N/A,13,AGDOSU,AG Dose Units,The unit associated with the procedure/assessment agent.,What is the unit (for the dose of the [procedure/assessment agent])?,(Dose) Unit,Char,R/C,"Record the dose unit of the [procedure agent] administered (e.g., mg).",AGDOSU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),(CMDOSU),"When sponsors collect data for amount of dose administered (i.e., Dose, Total Daily Dose), the unit must be collected as well (if applicable).",13
Interventions,AG,N/A,N/A,14,AGDOSFRM,AG Dose Form,The pharmaceutical dosage form in which the AGTRT is physically presented.,What was the dose form of the [procedure/assessment agent]?,Dose Form,Char,O,"Record the pharmaceutical dosage form (e.g., TABLET CAPSULE SYRUP) for the [procedure agent] [administered].",AGDOSFRM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FRM),(CMDOSFRM),"Some drugs have multiple forms and this field may be needed to code the drug to an ATC level. However, in general, this level of detail should not be necessary except for procedure agents of interest.",14
Interventions,AG,N/A,N/A,15,AGDOSFRQ,AG Dosing Frequency per Interval,The number of doses administered during a specific interval.,What was the frequency of the [procedure/assessment agent]?,Frequency,Char,O,"Record how often the [procedure agent] was administered (e.g., ONCE).",AGDOSFRQ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(FREQ),(CMDOSFRQ),"The frequency of the procedure agent. When collected, the recommendation is to collect dosing information in separate fields (e.g., AGDOSE, AGDOSEU, AGDOSFRQ) for specific and consistent data collection and to enable programmatically utilizing these data.",15
Interventions,AG,N/A,N/A,16,AGROUTE,AG Route of Administration,The route of administration of the procedure/assessment agent.,What was the route of administration of the [procedure/assessment agent]?,Route,Char,R/C,Provide the route of administration for the [procedure agent].,AGROUTE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ROUTE),(CMROUTE),"This additional information may be important to collect on the CRF when the sponsor wants to capture a procedure agent's route of administration, for purposes such as coding, and the procedure agent may have more than 1 route. Some companies may use route in coding procedure agents to be able to choose a precise preferred name and ATC code.",16
Interventions,AG,N/A,N/A,17,AGSTDAT,Procedure Agent Start Date,"The start date when the procedure/assessment agent was first administered, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the procedure/assessment agent] start date?,Start Date,Char,R/C,Record the date the procedure agent was first administered using this format (DD-MON-YYYY). Procedure agent(s) administered during the study are expected to have a complete start date.,AGSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable AGSTDTC in ISO 8601 format.",N/A,N/A,"The assumption is that sponsors should either have a start date or will indicate that the procedure agent was started before, during or after the study period. The preferred method is to collect a complete start date. Partial dates (e.g., providing year only) for procedure agent started a considerable amount of time prior to the start of study are acceptable.",17
Interventions,AG,N/A,N/A,18,AGSTTIM,Procedure Agent Start Time,"The time the procedure/assessment agent was started, represented in an ambiguous time format (e.g., h:mm:ss).",What was the [procedure/assessment agent] start time?,Start Time,Char,R/C,Record the time (as complete as possible) that the [procedure agent] was started.,AGSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable AGSTDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a procedure agent was started only when a protocol or data collection scenarios supports it. Typically, a start time is not collected unless the subject is under the direct care of the site at the time a procedure agent administered or the subject records the start time in a diary. See Mapping Relative Times from Collection to Submissions, and the SDTMIG for more information.",18
Interventions,AG,N/A,N/A,19,AGPRIOR,Prior Procedure Agents,Indication the procedure/assessment agent was administered prior to [AGSTTPT] or prior to the date in DM.RFSTDTC.,Was the [procedure/assessment agent] administered prior to AGSTTPT? Was the procedure/assessment agent given prior to study start?,Prior to [AGSTTPT]; prior to study,Char,O,Check if the [procedure agent] was started before the study.,AGSTRF; AGSTRTPT,"This does not map directly to an SDTMIG variable. May be used to populate a value into an SDTMIG relative timing variable such as AGSTRF or AGSTRTPT. When populating AGSTRF or AGSTRTPT, if the value of the CDASH field AGPRIOR is ""Y"", a value from the CDISC CT (STENRF) may be used. When AGPRIOR refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC), the SDTMIG variable AGSTRF should be populated. When AGPRIOR is compared to another time point, the SDTMIG variables AGSTRTPT and AGSTTPT should be used. Note: AGSTRTPT must be in reference to the time-point anchor described in AGSTTPT.",(NY),N/A,"Sponsors may collect this information rather than start dates. See Mapping Relative Times from Collection to Submissions, and the SDTMIG for more information.",19
Interventions,AG,N/A,N/A,20,AGONGO,Ongoing Procedure Agents,Indication the procedure/assessment agent is ongoing when no end date is provided.,Was the [procedure/assessment agent] ongoing (as of the [study-specific time point or period])?,Ongoing (as of [the study-specific time point or period]),Char,R/C,"Record the [procedure agent] as ongoing if the subject has not stopped taking the procedure agent at [the time point defined by the study]. If the procedure agent is ongoing, the end date should be left blank.",AGENRF; AGENRTPT,"This does not map directly to an SDTMIG variable. May be used to populate a value into an SDTMIG relative timing variable such as AGENRF or AGENRTPT. When populating AGENRF, if the value of AGONGO is ""Y"", the values of ""DURING"", ""AFTER"" or ""DURING/AFTER"" may be used. When populating AGENRTPT, if the value of AGONGO is ""Y"", the value of ""ONGOING"" may be used. When AGONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC), the SDTMIG variable AGENRF should be populated. When AGONGO is used in conjunction with another time point, the SDTMIG variables AGENRTPT and AGENTPT should be used. Note: AGENRTPT must be in reference to the time-point anchor described in AGENTPT.",(NY),N/A,"This box should be checked to indicate that theprocedure agent has not stopped at the time of data collection. It is expected that every recorded procedure agent should have either an end date or be checked as ongoing, but not both. However, in cases where ongoing procedure agents are not permitted, it may not be necessary to include an Ongoing field in the CRF. See Mapping Relative Times from Collection to Submission, for more information about collecting relative date/time; see the SDTMIG for information about mapping relative times.",20
Interventions,AG,N/A,N/A,21,AGENDAT,Procedure Agents End Date,"The date the procedure/assessment agent was stopped/ended, represented in an unambiguous date format (e.g. DD-MON-YYYY).",What was the [procedure/assessment agent's] end date?,End Date,Char,R/C,Record the date the procedure agent was topped using this format (DD-MM-YYYY). If the subject has not stopped [administering/being administered] the procedure agent leave this field blank.,AGENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable CMENDTC in ISO 8601 format.",N/A,N/A,"The assumption is that sponsors should either have an end date or will indicate that the procedure agent was ongoing at the time of collection or at the end of the study. However, in cases where the end date can be determined from dates collected elsewhere in the CRF it is not necessary to include an end date in the CRF. For example, if all procedure agents are administered only once during a trial, the end date will be the same as the start date.",21
Interventions,AG,N/A,N/A,22,AGENTIM,Procedure Agents End Time,"The time the concomitant medication/treatment/therapy was started, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [procedure/assessment agent's] end time?,End Time,Char,R/C,Record the time (as complete as possible) that the procedure agent was stopped.,AGENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable AGENDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a procedure agent was ended only when a protocol or data collection scenarios require it or the subject records the end time in a diary. Typically, an end time is not collected unless the subject is under the direct care of the site at the time a procedure agent is stopped.",22
Interventions,AG,N/A,N/A,23,AGDECOD,Standardized Agent Name,"The dictionary or sponsor-defined standardized text description of the topic variable (AGTRT) or the modified topic variable (AGMODIFY), if applicable.",N/A,N/A,Char,O,N/A,AGDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This is typically not a data collection field that will appear on the CRF. If the sponsor chooses to code the procedure, the sponsor will populate this through the coding process. If PRPRESP is used, and the information about a specific standardized procedure name is being solicited, the data from AGTRT may map directly to the SDTMIG AGDECOD variable.",23
Interventions,AG,N/A,N/A,24,AGCLAS,AG Agent Class,"The class for the agent, often obtained from a coding dictionary.",N/A,N/A,Char,O,N/A,AGCLAS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This would generally be the class used for analysis.,24
Interventions,AG,N/A,N/A,25,AGCLASCD,AG Agent Class Code,The assigned dictionary code for the class of agent.,N/A,N/A,Num,O,N/A,AGCLASCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This would generally be the class code used for analysis.,25
Events,AE,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",1
Events,AE,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed for the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,AE,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Events,AE,N/A,N/A,4,AEYN,Any Adverse Event,An indication of whether any AEs were experienced during the study.,Were any adverse events experienced?,Any Adverse Events,Char,O,"Indicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,4
Events,AE,N/A,N/A,5,AECAT,Category for Adverse Event,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the adverse event?,[Adverse Event Category]; NULL,Char,O,"Record the adverse event category, if not pre-printed on the CRF.",AECAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading.",5
Events,AE,N/A,N/A,6,AESCAT,Subcategory for Adverse Event,A sub-division of the AECAT values based on user-defined characteristics.,What is the subcategory of the adverse event?,[Adverse Event Subcategory]; NULL,Char,O,"Record the adverse event subcategory, if not pre-printed on the CRF.",AESCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. AESCAT can only be used if there is an AECAT and it must be a subcategorization of AECAT.,6
Events,AE,N/A,N/A,7,AESPID,AE Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.",AESPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medications, procedures and/or medical history records with AEs. If CMAENO or PRAENO is used, this is the identifier to which CMAENO or PRAENO refers. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",7
Events,AE,N/A,N/A,8,AETERM,Reported Term for the Adverse Event,The reported or pre-specified name of the adverse event.,What is the adverse event term?,Adverse Event,Char,HR,"Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise enter a sign or symptom.",AETERM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Can be represented either as an open-entry field to capture verbatim terms reported by subjects or pre-printed, in the situation where solicited AEs of interest are captured. In most cases, the verbatim term (i.e., investigator-reported term) will be coded to a standard medical dictionary (e.g., MedDRA, WHO ART) after the data have been collected on the CRF.",8
Events,AE,N/A,N/A,9,AEOCCUR,Adverse Event Occurrence,An indication of whether a pre-specified adverse event or a group of adverse events occurred when information about the occurrence of a specific event is solicited.,Did the subject have [pre-specified adverse event/group of adverse events]?,[Specific Adverse Event ],Char,O,"Indicate if [specific adverse event] has occurred/is occurring, by checking Yes or No.",FAORRES,"This does not map directly to an SDTMIG variable. Because the SDTM AE domain is intended to hold only adverse events that actually happen, all values collected in AEOCCUR for pre-specified AEs should be submitted in a Findings About Adverse Events data set (FAAE) where FAORRES=the value of AEOCCUR where FATESTCD=""OCCUR"". In addition, where AEOCCUR=""Y"", there should be a corresponding record in the AE domain.",(NY),N/A,"The CDASH variable AEOCCUR is used to indicate the occurrence of pre-specified adverse events (e.g., ""Did the subject have high blood pressure?""). AEOCCUR should not be used for spontaneously reported adverse events. The site should be able to indicate that the response was not asked or answered.",9
Events,AE,N/A,N/A,10,AEPRESP,Pre-specified Adverse Event,An indication that a specific event or group of events are pre-specified on a CRF.,N/A,N/A,Char,O,N/A,AEPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"A hidden field on a CRF defaulted to ""Y"", or added during SDTM-based dataset creation, when the AE is pre-specified. Null for spontaneously reported events. If a study collects both pre-specified and free-text adverse events, the value of AEPRESP should be ""Y"" for all pre-specified events and null for events reported as free-text. AEPRESP is a permissible field in SDTM and may be omitted from the SDTM-based dataset if all events were collected as free text.",10
Events,AE,N/A,N/A,11,AESTDAT,Adverse Event Start Date,"The start date of the adverse event, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What is the adverse event start date?,Start Date,Char,HR,Record the start date of the adverse event using this format (DD-MON-YYYY).,AESTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable AESTDTC in ISO 8601 format.",N/A,N/A,N/A,11
Events,AE,N/A,N/A,12,AESTTIM,Start Time of Adverse Event,"The start time of the adverse event, represented in an unambiguous time format (e.g., hh:mm:ss).",What is the adverse event start time?,Start Time,Char,R/C,Record the start time (as complete as possible) of the adverse event.,AESTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable AESTDTC in ISO 8601 format.",N/A,N/A,Collecting the time an AE started is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. An example is where the subject is under the direct care of the site at the time the event started and the study design is such that it is important to know the AE start time with respect to dosing.,12
Events,AE,N/A,N/A,13,AELOC,AE Location of Event,A description of the anatomical location relevant for the adverse event.,What is the anatomical location of the adverse event?,Anatomical Location,Char,O,Indicate the anatomical location of the adverse event.,AELOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, PORTOT are used to further describe the anatomical location.",13
Events,AE,N/A,N/A,14,AELAT,Adverse Event Laterality,"Qualifier for anatomical location, further detailing the side of the body relevant for the event.",What is the side of the anatomical location of the adverse event?,Side,Char,O,Record the side of the anatomical location of the adverse event.,AELAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,14
Events,AE,N/A,N/A,15,AEDIR,Adverse Event Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What is the directionality of the anatomical location of the adverse event?,Directionality,Char,O,Record the directionality of the anatomical location of the adverse event.,AEDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,15
Events,AE,N/A,N/A,16,AEPORTOT,AE Location Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of).",What is the portion or totality of the anatomical location of the adverse event?,Portion or Totality,Char,O,Indicate the portion or totality anatomical location of the adverse event.,AEPORTOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(PORTOT),N/A,Collected when the sponsor needs to identify the specific portionality for the anatomical locations. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,16
Events,AE,N/A,N/A,17,AEONGO,Ongoing Adverse Event,Indication that an adverse event is ongoing when no end date is provided.,Is the adverse event ongoing (as of [the study-specific time point or period])?,Ongoing (as of [the study-specific time point or period]),Char,O,Indicate if the adverse event has not resolved at the time of data collection; leave the End Date blank.,AEENRTPT; AEENRF,"This does not map directly to an SDTMIG variable. May be used to populate a value into an SDTMIG relative timing variable such as AEENRF or AEENRTPT. When populating AEENRF, if the value of AEONGO is ""Y"", the value of ""DURING"", ""AFTER"" or ""DURING/AFTER"" may be used. When populating AEENRTPT, if the value of AEONGO is ""Y"", the value of ""ONGOING"" may be used. When AEONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTMIG variable AEENRF should be populated. When AEONGO is compared to another time point, the SDTMIG variables AEENRTPT and AEENTPT should be used. Note: AEENRTPT must refer to a time-point anchor described in AEENTPT.",(NY),N/A,"Completed to indicate that the AE has not resolved at the time of data collection, when no end date is collected. In some cases the ongoing status may be determined from AE Outcome. The purpose of collecting this field is to help with data cleaning and monitoring; this field provides further confirmation that End Date was deliberately left blank. Often used as a tick/checkbox.",17
Events,AE,N/A,N/A,18,AEENDAT,Adverse Event End Date,"The date when the adverse event resolved/ended, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the adverse event end date?,End Date,Char,R/C,"Record the date that the adverse event. resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.",AEENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable AEENDTC in ISO 8601 format.",N/A,N/A,"The definition of resolved is sponsor-specific. The preferred method is to collect a complete end date (if applicable). Partial dates (e.g., providing year only, month and year only) may be acceptable.",18
Events,AE,N/A,N/A,19,AEENTIM,End Time of Adverse Event,"The time when the adverse event ended/resolved, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the adverse event end time?,End Time,Char,R/C,Record the time (as complete as possible) that the adverse event resolved.,AEENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable AEENDTC in ISO 8601 format.",N/A,N/A,Collecting the time an AE resolved is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. An example is where the subject is under the direct care of the site at the time the event resolved and the study design is such that it is important to know the AE end time with respect to dosing.,19
Events,AE,N/A,N/A,20,AESEV,AE Severity/Intensity,The severity or intensity of the event.,What is the severity of the adverse event?,Severity,Char,R/C,The reporting physician/healthcare professional will assess the severity of the event using the sponsor-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported adverse event to similar type events observed in clinical practice. Severity is not equivalent to seriousness.,AESEV,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(AESEV),N/A,Either AESEV or AETOXGR must appear on the CRF. Some studies may mandate the collection of both. Refer to ICH E3 (Guideline for Industry Structure and Content of Clinical Study)/Section 12.2.4.,20
Events,AE,N/A,N/A,21,AETOXGR,AE Standard Toxicity Grade,"The grade of the severity of the event using a standard ""toxicity"" scale (e.g., NCI CTCAE).",What is the [NCI CTCAE/Name of scale (toxicity) grade] of the adverse event?,[NCI CTCAE/ Name of the scale] (Toxicity) Grade,Char,R/C,The reporting physician/healthcare professional will assess the severity of the adverse event using the specified grades scale.,AETOXGR,Maps directly to the SDTMIG variable listed in the SDTMIG Target columnget. The sponsor is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external codelist attributes.,N/A,N/A,"Either AESEV or AETOXGR must appear on the CRF. Some studies may mandate the collection of both. Refer to ICH E3 Section 12.2.4. CTCAE grade is commonly used in oncology studies, although it can also be used elsewhere. Other published toxicity-like scales can also be used.",21
Events,AE,N/A,N/A,22,AESER,AE Serious Event,"An indication of whether the adverse event is determined to be ""serious,"" based on what is defined in the protocol.",Was the adverse event serious?,Serious,Char,R/C,"Assess if the adverse event should be classified as ""serious,"" based on the criteria defined in the protocol.",AESER,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"This field is related to the individual SAE-type fields, which may or may not be collected on the CRF. Either AESER or all the SAE-type fields must be present on the CRF. Sponsors should consult with regulatory agencies regarding the collection of this data.",22
Events,AE,N/A,N/A,23,AESDTH,Results in Death,An indication the serious adverse event resulted in death.,Did the adverse event result in death?,Death,Char,R/C,Record whether the serious adverse event resulted in death.,AESDTH,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data.",23
Events,AE,N/A,N/A,24,DTHDAT,Death Date,Date of death for any subject who died.,What [is/was] the subject's date of death?,Death Date,Char,O,Record the date of death.,DM.DTHDTC,"This field does not map directly to an SDTMIG variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DTHDTC in ISO 8601 format.",N/A,N/A,"In the CDASH model, Death Date is a timing variable; it is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the sponsor, but should only be collected once. The SDTMIG variable DTHDTC is mapped to the DM domain during the SDTM submission dataset creation process. The SDTMIG variable DM.DTHFLG is not a CDASH variable, but it is typically populated during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains, as deemed appropriate by the sponsor (e.g., DS).",24
Events,AE,N/A,N/A,25,AESLIFE,Is Life Threatening,An indication the serious adverse event was life threatening.,Was the adverse event life threatening?,Life Threatening,Char,R/C,Record whether the serious adverse event is life threatening.,AESLIFE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data.",25
Events,AE,N/A,N/A,26,AESHOSP,Requires or Prolongs Hospitalization,An indication the serious adverse event resulted in an initial or prolonged hospitalization.,Did the adverse event result in initial or prolonged hospitalization for the subject?,Hospitalization (initial or prolonged),Char,R/C,Record whether the serious adverse event resulted in an initial or prolonged hospitalization.,AESHOSP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data.",26
Events,AE,N/A,N/A,27,AESDISAB,Persist or Signif Disability/Incapacity,An indication the serious adverse event was associated with a persistent or significant disability or incapacity.,Did the adverse event result in disability or permanent damage?,Disability or Permanent Damage,Char,R/C,Record whether the serious adverse event resulted in a persistent or significant disability or incapacity.,AESDISAB,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data.",27
Events,AE,N/A,N/A,28,AESCONG,Congenital Anomaly or Birth Defect,An indication the serious adverse event was associated with a congenital anomaly or birth defect.,Was the adverse event associated with a congenital anomaly or birth defect?,Congenital Anomaly or Birth Defect,Char,R/C,Record whether the serious adverse event was associated with congenital anomaly or birth defect.,AESCONG,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data.",28
Events,AE,N/A,N/A,29,AESINTV,Needs Intervention to Prevent Impairment,"An indication an adverse event required medical or surgical intervention to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, due to the use of a medical product.",Did the adverse event require intervention to prevent permanent impairment or damage resulting from the use of a medical product?,Needs Intervention to Prevent Impairment,Char,O,Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.,SUPPAE.QVAL,This does not map directly to an SDTMIG variable. Sponsors should see requirements for the reporting of adverse events involving medical devices. Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data.",29
Events,AE,N/A,N/A,30,AESMIE,Other Medically Important Serious Event,An indication additional categories for seriousness apply.,Was the adverse event a medically important event not covered by other serious criteria?,Other Serious (Important Medical Events),Char,R/C,"Record whether the serious adverse event is an ""important medical event,"" which may be defined in the protocol or in the investigator brochure.",AESMIE,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data.",30
Events,AE,N/A,N/A,31,AESCAN,Involves Cancer,An indication the serious event was associated with the development of cancer.,Was the adverse event associated with the development of cancer?,Cancer,Char,O,Record whether the serious adverse event was associated with development of cancer.,AESCAN,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data. ""Involves cancer"" (AESCAN) and ""Occurred with overdose"" (AESOD) are not part of the ICH definition of an SAE, but these categories are available for use in studies conducted under guidelines that existed prior to the FDA's adoption of the ICH definition.",31
Events,AE,N/A,N/A,32,AESOD,Occurred with Overdose,An indication the serious event occurred with an overdose.,Did the adverse event occur with an overdose?,Overdose,Char,O,Record whether the serious adverse event occurred with an overdose.,AESOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Sponsors should consult with regulatory agencies regarding the collection of this data. ""Involves cancer"" (AESCAN) and ""Occurred with overdose"" (AESOD) are not part of the ICH definition of an SAE, but these categories are available for use in studies conducted under guidelines that existed prior to the FDA's adoption of the ICH definition.",32
Events,AE,N/A,N/A,33,AEREL,AE Causality,"An indication the study treatment had a causal effect on the adverse event, as determined by the clinician/investigator.",Was this adverse event related to study treatment?,Relationship to Study Treatment,Char,HR,"Indicate if the cause of the adverse event is related to the study treatment and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions).",AEREL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology is used to indicate the relationship between the AE and the study treatment (e.g., ICH E2B examples include ""Not Related"", ""Unlikely Related"", ""Possibly Related"", ""Related""). Another possibility is the use of ""Y"" and ""N"". CDISC Controlled Terminology may be defined in the future. It is recommended that sponsors check with the appropriate regulatory authority for population of this variable to ensure it meets expectations for submission. There is no industry-wide controlled terminology for relationship to treatment. It is recommended that sponsors establish terminology and apply it consistently.",33
Events,AE,N/A,N/A,34,AEACN,Action Taken with Study Treatment,A description of the action taken with study treatment as a result of the event.,What action was taken with study treatment?,Action Taken with Study Treatment,Char,R/C,Record changes made to the study treatment resulting from the adverse event.,AEACN,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ACN),N/A,"CDISC Controlled Terminology is used to indicate the action taken with the study treatment in response to the AE. How to handle multiple actions taken is up to the sponsor. If this information is collected elsewhere (e.g., on the Exposure CRF), then it is not required to be collected on the AE CRF. This variable is not to be used for actions taken with devices. See the SDTMIG-MD for information on reporting multiple actions, or actions with multiple devices.",34
Events,AE,N/A,N/A,35,AEACNDEV,Actions Taken with Device,"A description of the action taken, with respect to a device used in a study (which may or may not be the device under study), as a result of the event.",What action was taken with a device used in the study?,Action Taken with Device,Char,O,Record actions taken resulting from the adverse event that are related to a study or non-study device.,SUPPAE.QVAL,This does not map directly an SDTMIG variable. The sponsor may submit this data in a SUPPAE dataset where SUPPAE.QNAM = "AEACNDEV" and SUPPAE.QLABEL = "Actions Taken with Device". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,N/A,N/A,"Sponsor-defined controlled terminology for actions that are related to the device (e.g., device removed, primary care physician notified). See the SDTMIG-MD for information on reporting multiple actions, or actions with multiple devices.",35
Events,AE,N/A,N/A,36,AEACNOTH,Other Action Taken,A description of other action taken as a result of the event that is unrelated to dose adjustments of the study treatment.,What other action was taken?,Other Action Taken,Char,O,Record all other action(s) taken resulting from the adverse event that are unrelated to study treatments given because of this AE.,AEACNOTH,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This is usually collected as a free-text field. If possible/desired, the sponsor can create controlled terminology (e.g., treatment unblinded, primary care physician notified).",36
Events,AE,N/A,N/A,37,AEOUT,Outcome of Adverse Event,A description of the outcome of an event.,What is the outcome of this adverse event?,Outcome,Char,R/C,Record the appropriate outcome of the event in relation to the subject's status.,AEOUT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(OUT),N/A,"CDISC Controlled Terminology is used to indicate the outcome of the event as it relates to the subject's status. The Outcome controlled terminology includes ICH E2B values. The use of this field is the recommended way to describe whether and how the AE resolved. Because the outcome of an AE may be death, if this field is NOT used, be sure to provide another form, such as Disposition, with clear instructions to record deaths there.",37
Events,AE,N/A,N/A,38,AEDIS,AE Caused Study Discontinuation,An indication of whether the event caused the subject to discontinue from the study.,Did the adverse event cause the subject to be discontinued from the study?,Caused Study Discontinuation,Char,O,Record if the adverse event caused the subject to discontinue from the study.,SUPPAE.QVAL,"This does not map directly an SDTMIG variable. May be used to create a RELREC to link the AE to the Disposition record (see the SDTMIG). The sponsor may also submit this data in a SUPPAE dataset where SUPPAE.QNAM = ""AEDIS"" and SUPPAE.QLABEL = ""Caused Study Discontinuation"", if appropriate. Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains..",(NY),N/A,"Because the Action Taken field was defined to only collect changes made to the study treatment due to the AE, an additional field was created to identify the AE(s) that caused the subject to discontinue from the study. Some sponsors opt to capture this information only on the Subject Disposition CRF, whereas others choose to collect this data on both the Subject Disposition and AE CRFs, so the specific AE term(s) and related data can be identified. If the CRF is designed to link the DS and AE records, then RELREC can be used to identify that relationship.",38
Events,AE,N/A,N/A,39,AERLNSYN,AE Related to Non-Study Treatment,"An indication whether, in the investigator's opinion, the event may have been due to a treatment other than study treatment.",Was this adverse event due to treatment other than study treatment?,Related to Non-Study Treatment,Char,O,"Indicate if this adverse event was due to treatment other than study treatment. If Yes, briefly describe this non-study treatment relationship.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the CDASH AERELNST field on the CRF was deliberately left blank.,39
Events,AE,N/A,N/A,40,AERELNST,AE Relationship to Non-Study Treatment,Description of the investigator's opinion as to whether the adverse event may have been due to a treatment other than study treatment.,What is the relationship to non-study treatment?,Relationship to Non-Study Treatment,Char,O,Record the investigator's opinion as to whether the event may have been due to a treatment other than study treatment.,AERELNST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"May be reported as free text (e.g., ""MORE LIKELY RELATED TO ASPIRIN USE""). If possible/desired, sponsors can create controlled terminology.",40
Events,AE,N/A,N/A,41,AESI,Adverse Event of Special Interest,"An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it. Depending on the nature of the event, rapid communication by the trial sponsor to other parties (e.g., regulators) might also be warranted.",Is this event of special interest?,Adverse Event of Special Interest,Char,O,Record the investigator's opinion as to whether the event is an adverse event of special interest by the sponsor.,N/A,Does not map to an SDTM variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,"This CDASH field may be used just to trigger other CRF pages, or populate a value in AECAT or AESCAT. If submitted, this information could be submitted in a SUPPAE dataset where SUPPAE.QNAM = ""AESI"" and SUPPAE.QLABEL = ""Adverse Event of Special Interest. Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.",41
Events,AE,N/A,N/A,42,AEPATT,Pattern of Adverse Event,Used to indicate the pattern of the event over time.,What is the adverse event pattern?,Pattern,Char,O,"For each adverse event, check the pattern of the AE. If a single event, choose Single.",AEPATT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Used to report the pattern of the AE (e.g., ""INTERMITTENT"", ""CONTINUOUS"", ""SINGLE EVENT""). For crossover trials, it is NOT recommended to capture this field for intermittent AEs. Instead, the AE should have corresponding start and stop dates to capture when the AE started and stopped.",42
Events,AE,N/A,N/A,43,AECONTRT,Concomitant or Additional Trtmnt Given,An indication whether a concomitant or additional treatment given because of the occurrence of the event.,Was a concomitant or additional treatment given due to this adverse event?,Concomitant or Additional Treatment Given Due to This AE,Char,O,"Indicate if any non-study treatments were received because of this adverse event. If Yes, medications should be recorded on the ConMed CRF and procedures recorded on the Procedures CRF.",AECONTRT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"If medication data are reported, the CMAENO variable (on the CM CRF) may be used to collect the associated AE Identifier in order to populate RELREC. If procedures are reported, the PRAENO variable (on the PR CRF) may be used to collect the associated AE Identifier in order to populate RELREC.",43
Events,AE,N/A,N/A,44,AEMODIFY,AE Modified Reported Term,"If the value for AETERM is modified to facilitate coding, then AEMODIFY will contain the modified text.",N/A,N/A,Char,R/C,N/A,AEMODIFY,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This is not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process.,44
Events,AE,N/A,N/A,45,AEDECOD,AE Dictionary-Derived Term,"The dictionary or standardized text description of AETERM or the modified topic variable (AEMODIFY), if applicable.",N/A,N/A,Char,O,N/A,AEDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes.,N/A,N/A,This is typically not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process. Equivalent to the Preferred Term (PT) in MedDRA.,45
Events,AE,N/A,N/A,46,AELLT,AE Lowest Level Term,The dictionary-derived text description of the lowest level term.,N/A,N/A,Char,R/C,N/A,AELLT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,46
Events,AE,N/A,N/A,47,AELLTCD,AE Lowest Level Term Code,The dictionary-derived code for the lowest level term.,N/A,N/A,Num,R/C,N/A,AELLTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,47
Events,AE,N/A,N/A,48,AEPTCD,AE Preferred Term Code,The dictionary-derived code for the preferred term.,N/A,N/A,Num,R/C,N/A,AEPTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,48
Events,AE,N/A,N/A,49,AEHLT,AE High Level Term,The dictionary-derived text description of the high level term for the primary system organ class (SOC).,N/A,N/A,Char,R/C,N/A,AEHLT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,49
Events,AE,N/A,N/A,50,AEHLTCD,AE High Level Term Code,The dictionary-derived code for the high level term for the primary system organ class (SOC).,N/A,N/A,Num,R/C,N/A,AEHLTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,50
Events,AE,N/A,N/A,51,AEHLGT,AE High Level Group Term,The dictionary-derived text description of the high level group term for the primary system organ class (SOC).,N/A,N/A,Char,R/C,N/A,AEHLGT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,51
Events,AE,N/A,N/A,52,AEHLGTCD,AE High Level Group Term Code,The dictionary-derived code for the high level group term for the primary system organ class (SOC).,N/A,N/A,Num,R/C,N/A,AEHLGTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,52
Events,AE,N/A,N/A,53,AESOC,AE Primary System Organ Class,The dictionary-derived text description of the primary system organ class (SOC).,N/A,N/A,Char,R/C,N/A,AESOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as the AEBODSYS if the primary SOC was used for analysis.,53
Events,AE,N/A,N/A,54,AESOCCD,AE Primary System Organ Class Code,The dictionary-derived code for the primary system organ class (SOC).,N/A,N/A,Num,R/C,N/A,AESOCCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as AEBDSYCD if the primary SOC was used for analysis.,54
Events,AE,N/A,N/A,55,AEACNOYN,Any Other Actions Taken,An indication whether any other actions were taken in response to the adverse event that were unrelated to study treatment dose changes or other non-study treatments given because of this adverse event.,Were any other actions taken in response to this adverse event?,Any Other Action(s) Taken,Char,O,"Indicate whether any other action(s) were taken in response to the adverse event that are unrelated to study treatment dose changes or other non-study treatments given because of this event. If Yes, briefly describe these actions.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the AEACNOTH field on the CRF was deliberately left blank.,55
Events,CE,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Events,CE,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,CE,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Events,CE,N/A,N/A,4,CECAT,Category for Clinical Event,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the clinical event?,[Clinical Event Category]; NULL,Char,O,"Record the clinical event category, if not pre-printed on the CRF.",CECAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",4
Events,CE,N/A,N/A,5,CESCAT,Subcategory for Clinical Event,A sub-division of the CECAT values based on user-defined characteristics.,What is the subcategory of the clinical event?,[Clinical Event Subcategory]; NULL,Char,O,"Record the clinical event subcategory, if not pre-printed on the CRF.",CESCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. CESCAT can only be used if there is an CECAT and it must be a subcategorization of CECAT.,5
Events,CE,N/A,N/A,6,CEYN,Any Clinical Event,An indication of whether any clinical events were experienced during the study.,Were any clinical events experienced?,Any Clinical Events,Char,O,"Indicate if the subject experienced any clinical events. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,6
Events,CE,N/A,N/A,7,CESPID,CE Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",CESPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medications, procedures and/or medical history records with CEs. If CMCENO or PRCENO is used, this is the identifier to which CMCENO or PRCENO refers. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",7
Events,CE,N/A,N/A,8,CETERM,Reported Term for the Clinical Event,The reported or pre-specified name of the clinical event.,What is the clinical event term?,[Clinical Event]; Specify (Other/Details),Char,HR,Record the clinical event or [insert text corresponding to the specific clinical event].,CETERM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Can be represented either as a free-text field to capture verbatim terms reported by subjects; or pre-printed, in situation where solicited CEs of interest are captured. May be used as Specify Other field to collect more details on a pre-specified CEDECOD value, or when CEDECOD=Other. In most cases, the verbatim term (i.e., investigator-reported term) will be coded to a standard medical dictionary (e.g., MedDRA, WHO ART) after the data have been collected on the CRF",8
Events,CE,N/A,N/A,9,CEOCCUR,Clinical Event Occurrence,An indication of whether a pre-specified clinical event or a group of clinical events occurred when information about the occurrence of a specific event is solicited.,Did the subject have [pre-specified clinical event/group of clinical events ]?,[Specified Clinical Event],Char,O,Indicate if [specific clinical event] has occurred/is occurring by checking Yes or No.,CEOCCUR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,The CDASH variable CEOCCUR is used to report the occurrence of pre-specified clinical event not considered to be an adverse event by the sponsor. CEOCCUR should not be used for spontaneously reported events. The site should be able to indicate that the question was not asked or answered.,9
Events,CE,N/A,N/A,10,CEPRESP,Clinical Event Pre-specified,"An indication that a specific event, or group of events, are pre-specified on a CRF.",N/A,N/A,Char,O,N/A,CEPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"A hidden field on a CRF defaulted to ""Y"", or added during the SDTM-based dataset creation when the clinical event is pre-specified. Null for spontaneously reported events. If a study collects both pre-specified CEs and free-text events, the value of CEPRESP should be ""Y"" for all pre-specified events and null for events reported as free text. CEPRESP is a permissible field in SDTM and may be omitted from the SDTM-based dataset if all events were collected as free text.",10
Events,CE,N/A,N/A,11,CESTDAT,Clinical Event Start Date,"The start date of the clinical event, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the [clinical event] start date?,Start Date,Char,R/C,Record the start date of the [clinical event ] using this format (DD-MON-YYYY).,CESTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable CESTDTC in ISO 8601 format.",N/A,N/A,N/A,11
Events,CE,N/A,N/A,12,CESTTIM,Clinical Event Start Time,"The start time of the clinical event, represented in an unambiguous date format (e.g., hh:mm:ss).",What was the [clinical event] start time?,Start Time,Char,O,"If appropriate, record the start time (as complete as possible) of the [clinical event].",CESTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable CESTDTC in ISO 8601 format.",N/A,N/A,Collecting the time a CE started is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. An example is where the subject is under the direct care of the site at the time the event started and the study design is such that it is important to know the CE start time with respect to dosing.,12
Events,CE,N/A,N/A,13,CELOC,Clinical Event Location,A description of the anatomical location relevant for the clinical event.,What was the anatomical location of the [clinical event]?,Anatomical Location,Char,O,Indicate the anatomical location of the clinical event.,CELOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, PORTOT are used to further describe the anatomical location.",13
Events,CE,N/A,N/A,14,CELAT,Clinical Event Laterality,"Qualifier for anatomical location, further detailing the side of the body relevant for the event.",What was the side of the anatomical location of the [clinical event]?,Side,Char,O,Record the side of the anatomical location of the clinical event.,CELAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,14
Events,CE,N/A,N/A,15,CEDIR,Clinical Event Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the [clinical event]?,Directionality,Char,O,Record the directionality of the anatomical location of the clinical event.,CEDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,15
Events,CE,N/A,N/A,16,CEPORTOT,CE Location Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of).",What was the portion or totality of the anatomical location of the clinical event?,Portion or Totality,Char,O,Indicate the portion or totality of anatomical location of the clinical event.,CEPORTOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(PORTOT),N/A,Collected when the sponsor needs to identify the specific portionality for the anatomical locations. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,16
Events,CE,N/A,N/A,17,CEONGO,Ongoing Clinical Event,Indication the clinical event is ongoing when no end date is provided.,Was the [clinical event] ongoing (as of [the study-specific timepoint or period]?,Ongoing (as of the [study-specific timepoint or period]),Char,O,"Indicate if the clinical event has not resolved at the time of data collection. If ongoing, leave the end date blank.",CEENRTPT; CEENRF,"This does not map directly to an SDTMIG variable. May be used to populate a value into an SDTMIG relative timing variable (e.g., CEENRF, CEENRTPT). When populating CEENRF, if the value of CEONGO is ""Y"", the values of ""DURING"", ""AFTER"", or ""DURING/AFTER"" may be used. When populating CEENRTPT, if the value of CEONGO is ""Y"", the value of ""ONGOING"" may be used. When CEONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC), the SDTMIG variable CEENRF should be populated. When CEONGO is compared to another time point, the SDTMIG variables CEENRTPT and CEENTPT should be used. Note: CEENRTPT must refer to a time-point anchor described in CEENTPT.",(NY),N/A,"Completed to indicate that the CE has not resolved at the time of data collection, when no end date is collected. In some cases the ongoing status may be determined from CE Outcome. The purpose of collecting this field is to help with data cleaning and monitoring; this field provides further confirmation that the end date was deliberately left blank. Often used as a tick/checkbox.",17
Events,CE,N/A,N/A,18,CEENDAT,Clinical Event End Date,"The date when the clinical event resolved/ ended, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the [clinical event] end date?,End Date,Char,R/C,"Record the date that the [clinical event] resolved using this format (DD-MON-YYYY). If the [clinical event] is ongoing, leave the field blank.",CEENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable CEENDTC in ISO 8601 format.",N/A,N/A,"The definition of resolved is sponsor-specific. The preferred method is to collect a complete end date. Partial dates (e.g., providing year only, month and year only) may be acceptable.",18
Events,CE,N/A,N/A,19,CEENTIM,Clinical Event End Time,"The time when the clinical event ended/resolved, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [clinical event] end time?,End Time,Char,O,Record the time (as complete as possible) that the [clinical event] resolved.,CEENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable CEENDTC in ISO 8601 format.",N/A,N/A,Collecting the time an CE resolved is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. An example is where the subject is under the direct care of the site at the time the event resolved and the study design is such that it is important to know the CE end time with respect to dosing.,19
Events,CE,N/A,N/A,20,CESEV,CE Severity/Intensity,The severity or intensity of the event.,What was the severity of the [clinical event]?,Severity,Char,O,The reporting physician/healthcare professional will assess the severity of the event using the sponsor-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported clinical event to similar type events observed in clinical practice.,CESEV,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external codelist attributes.,N/A,N/A,Some studies may collect severity and/or toxicity grade.,20
Events,CE,N/A,N/A,21,CETOX,Clinical Event Toxicity Description,"A description of toxicity quantified by CETOXGR (e.g., NCI CTCAE Short Name).",What was the description of the toxicity?,[NCI CTCAE] Toxicity,Char,O,Record the description of the toxicity.,CETOX,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external code list attributes.,N/A,N/A,"This would typically be the text description quantified by CETOXGR (e.g., HYPERCALCEMIA, HYPOCALCEMIA).",21
Events,CE,N/A,N/A,22,CETOXGR,Clinical Event Toxicity Grade,"The toxicity grade using a standard toxicity scale (e.g., NCI CTCAE).",What was the toxicity grade?,[NCI CTCAE Toxicity] Grade,Char,O,Record the severity of the clinical event using the CTCAE toxicity grades.,CETOXGR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external codelist attributes.,N/A,N/A,Some studies may collect severity and/or toxicity grade. CDISC Controlled Terminology (TOXGRV3; TOXGRV4) may be used.,22
Events,CE,N/A,N/A,23,CEMODIFY,Clinical Event Modified Term,"If the value for CETERM is modified to facilitate coding, then CEMODIFY will contain the modified text.",N/A,N/A,Char,O,N/A,CEMODIFY,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This is not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process.,23
Events,CE,N/A,N/A,24,CEDECOD,CE Dictionary-Derived Term,"The dictionary- or sponsor-defined standardized text description of CETERM or the modified topic variable (CEMODIFY), if applicable.",N/A,N/A,Char,O,N/A,CEDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This is typically not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process. Equivalent to the Preferred Term (PT in MedDRA).,24
Events,CE,N/A,N/A,25,CELLT,Clinical Event Lowest Level Term,The dictionary-derived text description of the lowest level term.,N/A,N/A,Char,O,N/A,CELLT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,25
Events,CE,N/A,N/A,26,CELLTCD,Clinical Event Lowest Level Term Code,The dictionary-derived code for the lowest level term.,N/A,N/A,Num,O,N/A,CELLTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,26
Events,CE,N/A,N/A,27,CEPTCD,Clinical Event Preferred Term Code,The dictionary-derived code for the preferred term.,N/A,N/A,Num,O,N/A,CEPTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,27
Events,CE,N/A,N/A,28,CEHLT,Clinical Event High Level Term,The dictionary-derived text description of the high level term for the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,CEHLT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,28
Events,CE,N/A,N/A,29,CEHLTCD,Clinical Event High Level Term Code,The dictionary-derived code for the high level term for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,CEHLTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,29
Events,CE,N/A,N/A,30,CEHLGT,Clinical Event High Level Group Term,The dictionary-derived text description of the high level group term for the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,CEHLGT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,30
Events,CE,N/A,N/A,31,CEHLGTCD,CE High Level Group Term Code,The dictionary-derived code for the high level group term for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,CEHLGTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,31
Events,CE,N/A,N/A,32,CESOC,CE Primary System Organ Class,The dictionary-derived text description of the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,CESOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as the CEBODSYS if the primary SOC was used for analysis.,32
Events,CE,N/A,N/A,33,CESOCCD,CE Primary System Organ Class Code,The dictionary-derived code for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,CESOCCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as CEBDSYCD if the primary SOC was used for analysis.,33
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be prepopulated.",2
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,4,DSCAT,Category for Disposition Event,"A categorization of the disposition events, which is used to distinguish between disposition events, protocol milestones, and other events.",What was the category of the disposition?,[Disposition Category],Char,HR,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",DSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DSCAT),N/A,"This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. In this implementation scenario, DSCAT=""PROTOCOL MILESTONE"" or ""OTHER EVENT"".",4
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,5,DSSCAT,Subcategory for Disposition Event,A sub-division of the DSCAT values based on user-defined characteristics.,What was the subcategory of the disposition?,[Disposition Subcategory]; NULL,Char,O,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",DSSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. DSSCAT can only be used if there is an DSCAT and it must be a subcategorization of the Protocol Milestone or Other Event.,5
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,6,EPOCH,Epoch,"Trial Epoch (e.g., 'BLINDED TREATMENT', 'OPEN LABEL TREATMENT', 'SCREENING', 'RUN-IN') for which subject disposition is being collected.",What is the trial period for this disposition event?,Trial Period,Char,R/C,"Check the [epoch, or insert more appropriate wording] for which disposition event is being recorded.",EPOCH,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EPOCH),N/A,"If protocol milestones or other events are collected more than once in the study, EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as part of the title of the page; however, some companies have a standard CRF module that includes a pick-list of epochs. See the SDTMIG for further information regarding EPOCH.",6
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,7,DSDECOD,Standardized Disposition Term,The standardized terminology of the disposition term.,[Sponsor-defined],[Sponsor-defined],Char,R/C,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",DSDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. Both DSDECOD and DSTERM must be populated in SDTM.,(PROTMLST);(OTHEVENT),N/A,"Refer to the SDTMIG for guidelines for assigning DSCAT, DSTERM, and DSDECOD for events considered protocol milestones or other events. Where DSCAT = ""PROTOCOL MILESTONE"", DSTERM contains the verbatim (as collected) and/or standardized text; DSDECOD uses the extensible controlled terminology codelist (PROTMLST). Where DSCAT=""OTHER EVENT"", DSDECOD uses the extensible controlled terminology codelist (OTHEVENT).",7
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,8,DSTERM,Reported Term for the Disposition Event,The verbatim or pre-specified name of the disposition term.,[Sponsor-defined],[Sponsor-defined],Char,R/C,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended. \n \n \n \n \n",DSTERM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variables DSDECOD and DSTERM must be populated in SDTM.,N/A,N/A,"When defining protocol milestones or other events, sponsors may populate DSTERM and DSDECOD with the same value (e.g., RANDOMIZATION, INFORMED CONSENT OBTAINED). DSTERM may also be populated with a verbatim term, which is then standardized in DSDECOD.",8
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,9,DSSTDAT,Disposition Event Start Date,"The date of the specified protocol milestone (e.g., informed consent, randomization) represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the [protocol milestone/other event name] (start) date?,[Protocol Milestone/Other Event Name] (start) Date,Char,R/C,"Record the date of the protocol milestone/other event as defined in the protocol and/or CRF completion instructions, using this format (DD-MON-YYYY).",DSSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable DSSTDTC in ISO 8601 format.",N/A,N/A,Sponsors should define in the protocol and/or CRF completion instructions the criteria for completion of each protocol milestone/other event and its associated (start) date.,9
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,10,DSSTTIM,Disposition Event Start Time,"The time of the specified protocol milestone (e.g., informed consent, randomization) or other event, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [protocol milestone/other event name] (start) time?,[Protocol Milestone/Other Event Name] (start) Time,Char,O,Record the time (as complete as possible) as defined in the protocol and/or CRF completion instructions.,DSSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable DSSTDTC in ISO 8601 format.",N/A,N/A,Sponsors should define in the protocol and/or CRF completion instructions the criteria for completion of each protocol milestone/other event (start) time. Collecting the time of the event is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail.,10
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,11,DSUNBLND,Unblinded,An indication of whether the subject's treatment information was revealed to any unauthorized site personnel during the trial.,Was (study) treatment unblinded by the site?,Unblinded,Char,O,"Record ""Yes"" if the subject's treatment assignment was unblinded/unmasked intentionally due to an adverse event, or unintentionally for other reasons (e.g., an administrative action) during the subject's blinded/masked treatment.",DSTERM; DSDECOD,"This does not map directly to an SDTM variable. If the CDASH field DSUNBLIND=""Y"", then the SDTMIG variables DSDECOD and DSTERM=""TREATMENT UNBLINDED"" and DSCAT =""OTHER EVENT"". If DSUNBLIND=""N"", then the CRF should be annotated to indicate that this value is NOT SUBMITTED.",(NY),N/A,"If DSUNBLND is ""Yes"" and information was collected about the reason for the unblinding, populate DSCAT with ""OTHER EVENT"" and the SDTMIG variables DSTERM with the free text and DSDECOD with the standardized text (e.g., TREATMENT UNBLINDED). If DSUNBLND is ""Yes"", and the unblinding also resulted in the subject discontinuing the trial prematurely, be sure to capture the applicable discontinuation details. If the unblinding occurred due to an adverse event, DSTERM contains the text of the AE (if collected on the CRF) and in the AE domain the SDTMIG variable AEACNOTH (""Were any other actions taken in response to this adverse event?"") may include the text ""Treatment Unblinded"". DSUNBLND may also be used to document intentional unblinding at a protocol-defined point in the trial.",11
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",12
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be prepopulated.",13
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",14
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,4,DSCAT,Category for Disposition Event,"A categorization of the disposition events which is used to distinguish between disposition events, protocol milestones, and other events.",What was the category of the disposition?,[Disposition Category],Char,HR,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",DSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DSCAT),N/A,"This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. This is used to distinguish a DISPOSITION EVENT, a PROTOCOL MILESTONE, or an OTHER EVENT. In this implementation scenario, DSCAT=""DISPOSITION EVENT""",15
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,5,DSSCAT,Subcategory for Disposition Event,A sub-division of the DSCAT values based on user-defined characteristics.,What was the subcategory of the disposition?,[Disposition Subcategory]; NULL,Char,O,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",DSSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. DSSCAT can only be used if there is an DSCAT, and it must be a subcategorization of the Disposition event.",16
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,6,EPOCH,Epoch,"Trial epoch (e.g., 'BLINDED TREATMENT', 'OPEN LABEL TREATMENT', 'SCREENING', 'RUN-IN') for which subject disposition is being collected.",What is the trial period for this disposition event?,Trial Period,Char,R/C,"Check the [epoch, or insert more appropriate wording] for which disposition is being recorded.",EPOCH,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EPOCH),N/A,"If disposition events are collected more than once in the study, EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as part of the title of the page; however, some companies have a standard CRF module that includes a pick-list of epochs. See the SDTMIG for further information regarding EPOCH.",17
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,7,DSDECOD,Standardized Disposition Term,"The standardized terminology of the disposition term that describes whether a subject completed the study or a portion of a study (epoch), or the reason they did not complete.",What was the subject's status (at the EPOCH/study specific time frame)?,Status (at the EPOCH/study specific time frame),Char,R/C,"Document the subject's status at [insert text corresponding to the selected trial epoch/study specific time frame]. If the subject discontinued prematurely, record the primary reason for discontinuation.",DSDECOD,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. Both DSDECOD and DSTERM must be populated in the SDTM-based datasets. If DSTERM was collected as an ""Other, Specify"" free text, populate DSTERM with the free text and populate DSDECOD with the sponsor-defined standardized text. If DSDECOD was collected with no free text, populate DSTERM and DSDECOD in the SDTM-based dataset with the DSDECOD value that was collected.",(NCOMPLT),N/A,"DSDECOD can be used as the standardized coded list with DSTERM used to capture any ""Specify, Other"" information, or DSDECOD can be used on its own. For sponsor- and/or study-specific reasons for discontinuation, it is recommended that these reasons be pre-printed on the CRF, as subcategories of the appropriate standardized DSDECOD item. However, it is recommended to limit the use of sponsor and study-specific reasons in order to promote consistent use of terminology and permit the combination of data across multiple sponsors. Either DSTERM or DSDECOD must be on the CRF. Both may be used if DSTERM is used as a Specify, Other field.",18
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,8,DSTERM,Reported Term for the Disposition Event,"The verbatim or pre-specified name of the event. The reported or pre-specified name for how a subject completed the study or a portion of a study (epoch), or the reason they did not complete.","What was the subject's status?; If [DSDECOD], specify",[Status]; [Specify],Char,R/C,"Document the subject's status at [insert text corresponding to the selected trial epoch]. If the subject discontinued prematurely, record the primary reason for discontinuation. (Or, if used with a DECOD list) If Other is selected from the Status list, provide the verbatim reason.",DSTERM,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variables DSDECOD and DSTERM must be populated in SDTM. If DSTERM was collected as an ""Other, Specify"" free text, populate the SDTMIG variable DSTERM with the free text and populate DSDECOD with the sponsor-defined standardized text. If DSDECOD was collected with no free text, populate DSTERM and DSDECOD in the SDTM-based dataset with the DSDECOD value that was collected.",N/A,N/A,"If used with a DECOD list, free-text description of the subject's ""Other"" status. DSTERM is the verbatim term for subject status when Other is selected from the DSDECOD code list. This field would only be used with the prompt and completion instructions provided as a Specify, Other field in conjunction with DSDECOD. DSTERM may be used by itself when no code list is provided for DSDECOD on the CRF. Either DSTERM or DSDECOD must be on the CRF. DSTERM is required in the SDTM-based dataset.",19
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,9,DSSTDAT,Disposition Event Start Date,"The date of the specified disposition event (e.g., study completion or discontinuation), represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the disposition event date?,Disposition Event Date,Char,R/C,Record the date of disposition event as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY),DSSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable DSSTDTC in ISO 8601 format.",N/A,N/A,"Sponsors should define in the protocol and/or CRF completion instructions the criteria for completion of each epoch for which a Disposition CRF will be provided. Define also the date of completion or discontinuation. Only collect the date of the disposition event once. For example, if the date of the last dose is defined to mark the end of the treatment phase epoch, and is collected on the Exposure CRF, then this field would not be collected on the Disposition CRF. If not collected elsewhere, this field is collected on the Disposition CRF.",20
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,10,DSSTTIM,Disposition Event Start Time,"The time of the specified disposition event (e.g., study completion or discontinuation), represented in an unambiguous time format (e.g., hh:mm:ss).",What was the disposition event time?,Disposition Event Time,Char,O,"Record the time (as complete as possible) that the subject completed the study or portion of the study as defined in the protocol and/or CRF completion instructions. If the subject did not complete the study or portion of the study, record the time (as complete as possible) as defined in the protocol and/or CRF completion instructions.",DSSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable DSSTDTC in ISO 8601 format.",N/A,N/A,"Sponsors should define in the protocol and/or CRF completion instructions the criteria for completion of each epoch for which a Disposition CRF will be provided. Define also the date of completion or discontinuation. Collecting the time of completion or discontinuation is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. Typically, it is not recommended that a time be collected unless the subject is under the direct care of the site at the time of the event. Only collect the time of completion or discontinuation on the Disposition CRF module if the same information is not being collected on another CRF module. For example, if the time of the last dose is defined to mark the end of the treatment phase epoch, and is collected on the Drug Exposure CRF, then this field would not be collected on the Disposition CRF.",21
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,11,DTHDAT,Death Date,Date of death for any subject who died.,What [is/was] the subject's date of death?,Death Date,Char,O,Record the date of death,DM.DTHDTC,"This field does not map directly to an SDTMIG variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DTHDTC in ISO 8601 format.",N/A,N/A,"The CDASH model defines Death Date as a timing variable; this is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the sponsor, but should only be collected once. The SDTMIG variable DTHDTC is mapped to the DM domain during the SDTM submission dataset creation process. The SDTMIG variable DM.DTHFLG is not a CDASH variable, but is populated during the SDTM submission dataset creation process. Death Date may also be mapped to other SDTM domains (e.g., DS) as deemed appropriate by the sponsor.",22
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,12,DSCONT,Subject Continue,The plan for subject continuation to the next phase of the study or another study at the time of completion of the CRF.,Will the subject continue?,Subject Continue,Char,O,Record if the subject will be continuing to [the next phase of this study/related study] (sponsor to specify as appropriate).,SUPPDS.QVAL,This information could be submitted in a SUPPDS dataset as the value of SUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,"Sponsors should specify the next phase of the study or the related study on the CRF. Typically this is a prompt to aid in monitoring and data cleaning, and usually not submitted in a SUPPDS dataset.",23
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,13,DSNEXT,Next EPOCH,Identifies the study epoch or new study in which the subject will participate.,What is the next [epoch/period/study/trial] the subject will [continue to/enter/enroll]?,Next [Epoch/Period/Study/Trial],Char,O,Record the planned subsequent [study epoch/study] in which the subject intends to participate.,N/A,Sponsor-defined SDTMIG mapping.,N/A,N/A,"Sponsors should specify the next phase of the study or the related study on the CRF. The data are to be used to aid in monitoring and data cleaning. No specific SDTM-based dataset mapping rules are provided because the mapping depends on the situation (e.g., next epoch, next trial). Per sponsor decision, plans to enter the next epoch within a study may be included in the SDTM submission datasets (e.g., SE). Actual subject entry into the next study is submitted as part of Trial Design datasets of that study.",24
Events,DV,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Events,DV,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,DV,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Events,DV,N/A,N/A,4,DVCAT,Category for Protocol Deviation,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the protocol deviation?,[Protocol Deviation Category]; NULL,Char,O,"Record the deviation category, if not pre-printed on the CRF.",DVCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",4
Events,DV,N/A,N/A,5,DVSCAT,Subcategory for Protocol Deviation,A sub-division of the DVCAT values based on user-defined characteristics.,What is the subcategory of the protocol deviation?,[Protocol Deviation Subcategory]; NULL,Char,O,"Record the deviation event subcategory, if not pre-printed on the CRF.",DVSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. DVSCAT can only be used if there is an DVCAT, and it must be a subcategorization of DVCAT.",5
Events,DV,N/A,N/A,6,DVYN,Any Protocol Deviation,An indication of whether there were any protocol deviations.,Were there any protocol deviations?,Any Deviations,Char,O,"Enter Yes if a protocol deviation occurred and No if none occurred. Ensure that any adverse event which triggers a protocol deviation (e.g., concomitant medication use, newly discovered medical history) is noted in the respective CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,6
Events,DV,N/A,N/A,7,DVDECOD,Protocol Deviation Coded Term,The sponsor-defined standardized text for the name of the protocol deviation.,What was the (standardized) protocol deviation (term/(code)?,(Standardized) Protocol Deviation (Term),Char,R/C,Record protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms.,DVDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"DVTERM and DVDECOD may have the same value. If the CRF is collecting protocol deviations using a codelist of responses, then DVDECOD should be used to store the codelist response. Sponsors must use either DVDECOD or DVTERM on the CRF and, in some cases, both may be used. For example, if the CRF collects ""Specify, Other"" or similar additional free-text descriptions of codelist items, then DVTERM should be used to store the detailed descriptive text.",7
Events,DV,N/A,N/A,8,DVTERM,Protocol Deviation Term,The reported or pre-specified name of the protocol deviation.,What was the protocol deviation term?,(Specify) Protocol Deviation,Char,R/C,Record the appropriate code from the list of protocol deviation terms.,DVTERM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"DVTERM and DVDECOD may have the same value. If the CRF is collecting protocol deviations using a free-text field, then DVTERM should be used to store the free-text response. Sponsors may use either DVDECOD or DVTERM on the CRF, but a value in DVTERM is required in the SDTM-based datasets.",8
Events,DV,N/A,N/A,9,DVSTDAT,Deviation Start Date,"The start date of deviation, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the protocol deviation start date?,Start Date,Char,O,"Record the start date that the protocol deviation using this format (DD-MON-YYYY). This should be the start or occurrence of the protocol deviation, not the date it was discovered or reported.",DVSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable DVSTDTC in ISO 8601 format.",N/A,N/A,This may be derived if not collected on a CRF.,9
Events,DV,N/A,N/A,10,DVSTTIM,Deviation Start Time,"The start time of the deviation, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the protocol deviation start time?,Start Time,Char,O,"If appropriate, record the start time (as complete as possible) of the protocol deviation in an unambiguous time format (e.g., hh:mm:ss). This should be the start or occurrence of the protocol deviation, not the time it was discovered or reported.",DVSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable DVSTDTC in ISO 8601 format.",N/A,N/A,N/A,10
Events,DV,N/A,N/A,11,DVENDAT,Deviation End Date,"The end date of the deviation, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the protocol deviation end date?,End Date,Char,O,"Record the end date of the protocol deviation using this format (DD-MON-YYYY). This should be the date the protocol deviation stopped, not the date it was discovered or reported.",DVENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable DVENDTC in ISO 8601 format.",N/A,N/A,N/A,11
Events,DV,N/A,N/A,12,DVENTIM,Deviation End Time,"The end time of the deviation, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the protocol deviation end time?,End Time,Char,O,"If appropriate, record the end time (as complete as possible) of the protocol deviation in an unambiguous time format (e.g., hh:mm:ss). This should be the time the protocol deviation stopped, not the time it was discovered or reported.",DVENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable DVENDTC in ISO 8601 format.",N/A,N/A,N/A,12
Events,DV,N/A,N/A,13,DVSPID,DV Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",DVSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",13
Events,HO,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",1
Events,HO,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,HO,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Events,HO,N/A,N/A,4,HOYN,Any Healthcare Encounters,An indication of whether there were any healthcare encounters.,Were there any healthcare encounters?,Any Healthcare Encounters,Char,O,"Indicate if the subject experienced any healthcare encounters. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,4
Events,HO,N/A,N/A,5,HOCAT,Category for Healthcare Encounter,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the healthcare encounter?,[Healthcare Encounter Category]; NULL,Char,O,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",HOCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header. Examples include HOSPITALIZATION and OUTPATIENT.",5
Events,HO,N/A,N/A,6,HOSCAT,Subcategory for Healthcare Encounter,A sub-division of the HOCAT values based on user-defined characteristics.,What was the subcategory of the healthcare encounter?,[Healthcare Encounter Subcategory]; NULL,Char,O,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",HOSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. HOSCAT can only be used if there is an HOCAT, and it must be a subcategorization of HOCAT.",6
Events,HO,N/A,N/A,7,HOOCCUR,Healthcare Encounter Occurrence,An indication of whether a health encounter occurred when information about the occurrence of a specific event is solicited.,Did the subject have [prespecified healthcare encounter term]?,[prespecified Healthcare Encounter Term],Char,O,Indicate if [specific healthcare encounter/event topic] has occurred/is occurring by checking Yes or No.,HOOCCUR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,The CDASH variable HOOCCUR is used to report the occurrence of a pre-specified healthcare encounter. HOOCCUR is not used if the healthcare encounters are collected on the CRF in a manner that requires a free-text response. The site should be able to indicate in a separate item (or system variable) that the question was not asked or answered.,7
Events,HO,N/A,N/A,8,HOPRESP,Pre-specified Healthcare Encounter,"An indication that a specific event, or group of events, are specified on a CRF.",N/A,N/A,Char,O,N/A,HOPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"A hidden field on a CRF defaulted to ""Y"", or added during the SDTM-based dataset creation, when the healthcare encounter is pre-specified. Null for spontaneously reported events. If a study collects both pre-specified healthcare encounters as well as free-text events, the value of HOPRESP should be ""Y"" for all prespecified events and null for events reported as free-text. HOPRESP is a permissible field in SDTM and may be omitted from the SDTM-based dataset if all events were collected as free text.",8
Events,HO,N/A,N/A,9,HOREASND,Reason Healthcare Encounter Not Done,An explanation for why the data are not available.,What was the reason the data were not collected?,Reason Not Collected,Char,O,Provide the reason why the subject's Healthcare Encounters experience was not assessed.,HOREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The reason the data are not available may be chosen from a sponsor defined list (e.g., subject not asked) or entered as free text. When HOREASND is used, the SDTMIG variable HOSTAT should also be populated in the SDTM-based dataset.",9
Events,HO,N/A,N/A,10,HOSPID,HO Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor-defined],Char,O,"If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.",HOSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",10
Events,HO,N/A,N/A,11,HOTERM,Reported Term for Healthcare Encounter,The reported or pre-specified name of the healthcare encounter.,"What was the healthcare encounter?; If [HODECOD], specify",[Healthcare Encounter]; [Specify],Char,HR,"Record the healthcare encounter or if used with a HODECOD list, ""Other"" specify.",HOTERM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"If collected on the CRF, sponsors must use either HODECOD or HOTERM and in some cases, both may be used. If the CRF is collecting healthcare encounters using a standardized sponsor-defined code list (e.g., INPATIENT ER, ICU, SURGERY, GENERAL WARD, PROVIDER OFFICE - PRIVATE, PROVIDER OFFICE - HOSPITAL, GASTROENTEROLOGIST), then HODECOD may be used to store the code list response. If the CRF collects ""Specify, Other"" or similar additional free-text descriptions of code list items, then HOTERM may be used to store the detailed descriptive text. If HOTERM is entered only as free text, HODECOD would be populated through the sponsor's coding process.",11
Events,HO,N/A,N/A,12,HODECOD,HO Standardized Term,"The sponsor-defined standardized text description of HOTERM or the modified topic variable (HOMODIFY), if applicable.",What was the (standardized) healthcare encounter (term/code)?,(Standardized) Healthcare Encounter (Term),Char,R/C,Select the healthcare encounter.,HODECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"If collected on the CRF, sponsors must use either HODECOD or HOTERM and in some cases, both may be used. If the CRF is collecting healthcare encounters using a standardized sponsor defined code list (e.g., INPATIENT ER, ICU, SURGERY, GENERAL WARD, PROVIDER OFFICE-PRIVATE, PROVIDER OFFICE-HOSPITAL, GASTROENTEROLOGIST), then HODECOD may be used to store the code list response. If the CRF collects ""Specify, Other"" or similar additional free-text descriptions of code list items, then HOTERM may be used to store the detailed descriptive text. If HOTERM is entered only as free text, HODECOD would be populated through the sponsor's coding process.",12
Events,HO,N/A,N/A,13,HOSTDAT,Healthcare Encounter Start Date,"The start date the healthcare encounter, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the [healthcare encounter/HOTERM] [start/admission] date?,[Start/Admission] Date,Char,O,"Record the start date of the healthcare encounter (e.g., date of admission) using this format (DD-MON-YYYY).",HOSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable HOSTDTC in ISO 8601 format.",N/A,N/A,"The preferred method is to collect a complete start date. Partial dates (e.g., providing year only, month and year only) may be acceptable.",13
Events,HO,N/A,N/A,14,HOSTTIM,Healthcare Encounter Start Time,"The start time of the healthcare encounter, (e.g., time of admission), represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [healthcare encounter/HOTERM] [start/admission] time?,[Start/Admission] Time,Char,O,"Record the start time (as complete as possible ) of the healthcare encounter in an unambiguous time format (e.g., hh:mm:ss).",HOSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable HOSTDTC in ISO 8601 format.",N/A,N/A,N/A,14
Events,HO,N/A,N/A,15,HOENDAT,Healthcare Encounter End Date,"The end date of the healthcare encounter (e.g., date of discharge), represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the [healthcare encounter/HOTERM] [end/discharge] date?,[End/Discharge] Date,Char,O,Record the end date of the healthcare encounter using this format (DD-MON-YYYY).,HOENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable HOENDTC in ISO 8601 format.",N/A,N/A,"The preferred method is to collect a complete end date. Partial dates (e.g., providing year only, month and year only) may be acceptable.",15
Events,HO,N/A,N/A,16,HOENTIM,Healthcare Encounter End Time,"The end time of the healthcare encounter (e.g., time of discharge), represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [healthcare encounter/HOTERM] [end/discharge] time?,[End/Discharge]Time,Char,O,"Record the end time (as complete as possible) of the healthcare encounter in an unambiguous time format (e.g., hh:mm:ss).",HOENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable HOENDTC in ISO 8601 format.",N/A,N/A,N/A,16
Events,HO,N/A,N/A,17,HOCDUR,Healthcare Encounter Collected Duration,Collected duration of the healthcare encounter.,What was the duration of the [healthcare encounter/HOTERM]?,Duration,Char,O,Provide the duration of the healthcare encounter.,HODUR,"This does not map directly to an SDTMIG variable. For the SDTM-based dataset, concatenate the CDASH collected duration and collected duration unit and populate the SDTMIG variable HODUR in ISO 8601 Period format. Example: P1DT2H (for 1 day, 2 hours).",N/A,N/A,Collected duration of the healthcare encounter. Used only if collected on the CRF and not derived from the start and end date/times.,17
Events,HO,N/A,N/A,18,HOCDURU,HO Collected Duration Unit,Unit of the collected duration of the healthcare encounter. Used only if duration was collected on the CRF.,What was the duration unit of the [healthcare encounter/HOTERM]?,(Duration) Unit,Char,O,Select the appropriate duration unit of the healthcare encounter.,HODUR,"This does not map directly to an SDTMIG variable. For the SDTM-based dataset, concatenate the CDASH collected duration and collected duration unit and populate the SDTMIG variable HODUR in ISO 8601 Period format. Example: P1DT2H (for 1 day, 2 hours).",(UNIT),N/A,"To ensure data quality, it is recommended that the appropriate duration unit(s) be pre-printed on the (e)CRF. If only 1 unit is appropriate, no data entry would be required.",18
Events,HO,N/A,N/A,19,HOONGO,Ongoing Healthcare Encounter,Indication that the encounter is ongoing when no end date is provided.,Was the [healthcare encounter/HOTERM] ongoing(as of the[study-specific timepoint or period?,Ongoing as of the[study-specific timepoint or period],Char,O,Record the healthcare encounter as ongoing ('Y') if it has not stopped at[at the timepoint defined by the study].,HOENRF; HOENRTPT,"This does not map directly to an SDTM variable. May be used to populate a value into an SDTMIG relative timing variable (e.g., HOENRF, HOENRTPT). When populating HOENRF, if the value of HOONGO is ""Y"", the values of ""DURING"", ""AFTER"", or ""DURING/AFTER"" may be used. When populating HOENRTPT, if the value of HOONGO is ""Y"", the value of ""ONGOING"" may be used. When HOONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTMIG variable HOENRF should be populated. When HOONGO is compared to any other time point, the SDTMIG variables HOENRTPT and HOENTPT should be used. \n Note: HOENRTPT must refer to a time-point anchor described in HOENTPT.",(NY),N/A,"Completed to indicate that the healthcare encounter has not ended at the time of data collection. It is expected that every reported encounter has either an end date or the Ongoing field is populated, but not both. The purpose of collecting this field is to help with data cleaning and monitoring; this field provides further confirmation that End Date was deliberately left blank. Often used as a tick/checkbox. See Section 3.7, Mapping Relative Times from Collection to Submissions, and SDTMIG for more information.",19
Events,HO,N/A,N/A,20,HOREAS,Reason for the Healthcare Encounter,Denotes the reason for the healthcare encounter.,What was the reason for the [healthcare encounter/HOTERM]?,Reason for the Healthcare Encounter,Char,O,Provide the reason for the subject's Healthcare Encounters.,SUPPHO.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPHO dataset as the value of SUPPHO_QVAL where SUPPHO.QNAM ="HOREAS" and SUPPHO.QLABEL="Healthcare Encounter Reason". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,N/A,N/A,"To ensure data quality, it is recommended that the sponsor develop controlled terminology (e.g., LACK OF EFFICACY, ADVERSE EVENT, CHEMOTHERAPY, PHYSICAL THERAPY, INDICATION UNDER STUDY, NOT INDICATION UNDER STUDY). The sponsor may, however choose to collect this as free text or as a combination of pre-printed options and free text in the form of ""Specify, Other"".",20
Events,HO,N/A,N/A,21,HOAENO,Related Adverse Event ID,Identifier for the adverse event that precipitated this encounter.,"What was the identifier for the adverse event(s), which precipitated the [healthcare encounter/HOTERM]?",Adverse Event Identifier,Char,O,Record the identifier for the adverse event that precipitated this encounter.,N/A,"This does not map directly to an SDTMIG variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the Adverse Events domain.",N/A,N/A,"The intent is to establish a link between the healthcare encounter record and the AE that was the primary cause of the encounter. HOAENO can be used in RELREC to identify a relationship between records in HO dataset and records in the AE dataset. Other identifiers needed to create RELREC (e.g., HOMHNO) can be created as needed. See SDTMIG for information on RELREC.",21
Events,MH,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM- based dataset creation before submission.",1
Events,MH,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,MH,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Events,MH,N/A,N/A,4,MHYN,Any Medical History Event,An indication of whether there was any medical history to report.,Were any medical conditions or events reported?; Has the subject had any medical conditions or events?,Any Medical History,Char,O,"Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,4
Events,MH,N/A,N/A,5,MHCAT,Category for Medical History,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the medical history?,[Medical History Category]; NULL,Char,R/C,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",MHCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology (e.g., CARDIAC, GENERAL). This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header. This would be used when specific medical history (e.g., disease under study details) is captured, in addition to the general medical history.",5
Events,MH,N/A,N/A,6,MHSCAT,Subcategory for Medical History,A sub-division of the MHCAT values based on user-defined characteristics.,What was the subcategory of the medical history?,[Medical History Subcategory]; NULL,Char,O,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",MHSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Typically would be used when specific medical history (e.g., disease diagnosis) is captured, in addition to the general medical history. MHSCAT can only be used if there is an MHCAT, and it must be a subcategorization of MHCAT.",6
Events,MH,N/A,N/A,7,MHDAT,Medical History Collection Date,"The date on which the medical history was collected, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the medical history was collected?,Collection Date,Char,O,Record the date on which the medical history was collected using this format (DD-MON-YYYY).,MHDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MHDTC in ISO 8601 format.",N/A,N/A,This should be a complete date. The date of collection may be determined from a collected visit date.,7
Events,MH,N/A,N/A,8,MHSPID,MH Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.",MHSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medications and/or procedure records with MH. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system. If CMMHNO or PRMHNO is used, this is the identifier to which CMMHNO or PRMHNO refers.",8
Events,MH,N/A,N/A,9,MHEVDTYP,Medical History Event Date Type,Specifies the aspect of the medical condition or event by which MHSTDTC and/or MHENDTC is defined.,What was the medical history event date type?,Medical History Event Date Type,Char,O,The instructions depend upon the format of the CRF. Sponsors may print these values on the CRF or use them as defaulted or hidden text.,MHEVDTYP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(MHEDTTYP),N/A,"The type of start/ and or end date (e.g.,, DIAGNOSIS, SYMPTOMS, RELAPSE, INFECTION). It is not related to the trial's condition. This date type cannot be a PRIMARY DIAGNOSIS, SECONDARY DIAGNOSIS because these terms do not define the date type.",9
Events,MH,N/A,N/A,10,MHTERM,Reported Term for the Medical History,The reported or pre-specified name of the medical condition or event.,What is the medical condition or event term?,Medical History Term,Char,HR,"Record all relevant medical conditions or events, as defined in the protocol. Record only 1 medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.",MHTERM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsors should collect all relevant medical conditions or events, as defined in the protocol. It is a best practice for sponsors to collect all relevant history of surgeries or procedures using the associated diagnosis in the MH domain, while reporting relevant surgeries and procedures in the SDTM PR domain. Sponsors should provide instructions on how surgeries and procedures will be handled based on the protocol requirements. Information on specified surgeries or procedures should be collected in the PR domain.",10
Events,MH,N/A,N/A,11,MHOCCUR,Medical History Occurrence,An indication of whether a pre-specified medical condition/event or a group of medical conditions/events occurred when information about the occurrence of a specific event is solicited.,Did the subject have [prespecified medical condition/event/group of medical conditions]; Is the [prespecified medical occurring]?,[Medical condition/Event],Char,O,Indicate if [specific medical condition/event] has occurred/is occurring by checking Yes or No.,MHOCCUR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,MHOCCUR is used to report the occurrence of specified medical conditions or events. MHOCCUR is not used if the medical conditions or events are collected on the CRF in a manner that requires spontaneously free-text response. The site should be able to indicate that the question was not asked or answered.,11
Events,MH,N/A,N/A,12,MHPRESP,Medical History Event Prespecified,"An indication that a specific event, or group of events, are pre-specified on a CRF.",N/A,N/A,Char,O,N/A,MHPRESP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"A hidden field on a CRF defaulted to ""Y"", or added during the SDTM-based dataset creation when the medical condition or event is prespecified. Null for spontaneously reported events. If a study collects both pre-specified medical history and free-text events, the value of MHPRESP should be ""Y"" for all pre-specified events and null for medical conditions or events reported as free text. MHPRESP is a permissible field in SDTM and may be omitted from the SDTM-based dataset if all events were collected as free text.",12
Events,MH,N/A,N/A,13,MHPRIOR,Prior Medical History Event,An indication of whether the event occurred prior to study start.,Did the medical condition or event start prior to [MHSTTPT]?; Did the medical condition or event start prior to study start?,Prior to [MHSTTPT]; Prior to Study,Char,O,Check if the medical condition or event started [before the study].,MHSTRTPT; MHSTRF,"This does not map directly to an SDTM variable. May be used to populate a value into an SDTMIG relative timing variable such as MHSTRF or MHSTRTPT. When populating MHSTRF, or MHSTRTPT, if the value of the CDASH field MHPRIOR is ""Y"" a value from the CDISC CT (STENRF) may be used. When MHPRIOR refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTMIG variable MHSTRF should be populated. When MHPRIOR is compared to another time point, the SDTMIG variables MHSTRTPT and MHSTTPT should be used. Note: MHSTRTPT must refer to the time-point anchor described in MHSTTPT.",(NY),N/A,"Sponsors may collect this information rather than start dates. See Section 3.7, Mapping Relative Times from Collection to Submissions, and SDTMIG v3.2 Section 4.1.4.7 for more information.",13
Events,MH,N/A,N/A,14,MHONGO,Ongoing Medical History Event,Indication the medical condition or event is ongoing when no end date is provided.,Is the medical condition or event ongoing (as of the [study-specific timepoint or period])?,Ongoing (as of the [study-specific timepoint or period]),Char,O,"Record the medical condition or event as ongoing (""Y"") if it has not ended at the time of data collection. If the medical condition or event is ongoing, the end date should be left blank.",MHENRF; MHENRTPT,"This does not map directly to an SDTM variable. May be used to populate a value into an SDTMIG relative timing variable such as MHENRF or MHENRTPT. When populating MHENRF, if the value of MHONGO is ""Y"", the value of ""DURING"", ""AFTER"" or ""DURING/AFTER"" may be used. When populating MHENRTPT, if the value of MHONGO is ""Y"", the value of ""ONGOING"" may be used. When MHONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the SDTMIG variable MHENRF should be populated. When MHONGO is compared to another time point, the SDTMIG variables MHENRTPT and MHENTPT should be used. \n Note: MHENRTPT must refer to a time-point anchor described in MHENTPT.",(NY),N/A,"Completed to indicate that the condition has not resolved at the time of data collection. It is expected that every reported condition has either an end date or the Ongoing field is populated, but not both. See Section 3.7, Mapping Relative Times from Collection to Submissions, and SDTMIG v3.2 Section 4.1.4.7 for more information.",14
Events,MH,N/A,N/A,15,MHCTRL,MH Disease or Symptom Under Control,Indication of whether the medical condition or event is under control at the time of data collection.,Is the medical condition or event under control?,Medical Condition Under Control,Char,O,Select the most appropriate response.,SUPPMH.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPMH dataset as the value of SUPPMH.QVAL where SUPPMH.QNAM ="MHCTRL" and SUPPMH.LABEL="Medical Condition Under Control". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,"MHCTRL is not defined in the SDTMIG MH domain. If collected, it should be submitted in the SUPPMH dataset. If MHCTRL is collected, the sponsor must provide information on the relative timeframe. Generally, MHDAT is collected or determined using the visit date of the collection to indicate this is the subject's status at the time of data collection.",15
Events,MH,N/A,N/A,16,MHSTDAT,Medical History Event Start Date,"The start date of medical history event or condition, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What [is/was] the [medical event or condition/category of the event] start date?,Start Date,Char,O,Record the start date of the medical event or condition using this format (DD-MON-YYYY).,MHSTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH START DATE and TIME components and populate the SDTMIG variable MHSTDTC in ISO 8601 format.",N/A,N/A,"The sponsor may choose to capture a complete date or any variation thereof (e.g., month and year, year).",16
Events,MH,N/A,N/A,17,MHENDAT,Medical History Event End Date,"The end date of medical history event or condition, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What[is/was] the[medical event or condition/category of the event] end date?,End Date,Char,O,Record the end date of the medical event or condition using this format (DD-MON-YYYY).,MHENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable MHENDTC in ISO 8601 format.",N/A,N/A,"The sponsor may choose to capture a complete date or any variation thereof (e.g., month and year, year).",17
Events,MH,N/A,N/A,18,MHLOC,Medical History Event Location,A description of the anatomical location relevant for the medical condition or event.,What was the anatomical location of the medical condition or event?,Anatomical Location,Char,O,Indicate the anatomical location of the medical event or condition.,MHLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location (e.g., ARM for skin rash). Could be a defaulted or hidden field on the CRF for prespecified [MHTERM/Event Topic]. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, PORTOT are used to further describe the anatomical location.",18
Events,MH,N/A,N/A,19,MHLAT,Medical History Event Laterality,"Qualifier for anatomical location, further detailing the side of the body relevant for the event.",What was the side of the anatomical location of the medical condition or event?,Side,Char,O,Record the side of the anatomical location of the medical event.,MHLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,19
Events,MH,N/A,N/A,20,MHDIR,Medical History Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the medical condition or event?,Directionality,Char,O,Record the directionality of the anatomical location of the medical event.,MHDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,20
Events,MH,N/A,N/A,21,MHPORTOT,MH Event Location Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of).",What was the portion or totality of the anatomical location of the of the medical condition or event?,Portion or Totality,Char,O,Indicate the portion or totality anatomical location of the medical event.,MHPORTOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(PORTOT),N/A,Collected when the sponsor needs to identify the specific portionality for the anatomical locations. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,21
Events,MH,N/A,N/A,22,MHMODIFY,MH Modified Reported Term,"If the value for MHTERM is modified to facilitate coding, then MHMODIFY will contain the modified text.",N/A,N/A,Char,O,N/A,MHMODIFY,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This is not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process.,22
Events,MH,N/A,N/A,23,MHDECOD,MH Dictionary-Derived Term,"The dictionary text description of MHTERM or the modified topic variable (MH MODIFY), if applicable.",N/A,N/A,Char,O,N/A,MHDECOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This is typically not a data collection field that will appear on the CRF. Sponsors will populate this through the coding process. Equivalent to the Preferred Term (PT in MedDRA).,23
Events,MH,N/A,N/A,24,MHLLT,Medical History Event Lowest Level Term,The dictionary-derived text description of the lowest level term.,N/A,N/A,Char,O,N/A,MHLLT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,24
Events,MH,N/A,N/A,25,MHLLTCD,MH Event Lowest Level Term Code,The dictionary-derived code for the lowest level term.,N/A,N/A,Num,O,N/A,MHLLTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,25
Events,MH,N/A,N/A,26,MHPTCD,MH Event Preferred Term Code,The dictionary-derived code for the preferred term.,N/A,N/A,Num,O,N/A,MHPTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,26
Events,MH,N/A,N/A,27,MHHLT,Medical History Event High Level Term,The dictionary-derived text description of the high level term for the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,MHHLT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,27
Events,MH,N/A,N/A,28,MHHLTCD,MH Event High Level Term Code,The dictionary-derived code for the high level term for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,MHHLTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,28
Events,MH,N/A,N/A,29,MHHLGT,MH Event High Level Group Term,The dictionary-derived text description of the high level group term for the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,MHHLGT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,29
Events,MH,N/A,N/A,30,MHHLGTCD,MH Event High Level Group Term Code,The dictionary-derived code for the high level group term for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,MHHLGTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding.,30
Events,MH,N/A,N/A,31,MHSOC,MH Event Primary System Organ Class,The dictionary-derived text description of the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,MHSOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as MHBODSYS if the primary SOC was used for analysis.,31
Events,MH,N/A,N/A,32,MHSOCCD,MH Event Primary System Organ Class Code,The dictionary-derived code for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,MHSOCCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the dictionary name and version used to code utilizing the Define-XML external codelist attributes. Sponsors should include an Origin in the define metadata document to indicate that the data was "ASSIGNED".,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as MHBDSYCD if the primary SOC was used for analysis.,32
Findings,DA,N/A,Horizontal-Generic,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,DA,N/A,Horizontal-Generic,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,DA,N/A,Horizontal-Generic,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,DA,N/A,Horizontal-Generic,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column..,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,DA,N/A,Horizontal-Generic,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable DADTC in ISO 8601 format.",N/A,N/A,"The date the drug accountability assessments were collected can be determined from the Visit Date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the DA CRF using the date (DADAT) field.",5
Findings,DA,N/A,Horizontal-Generic,6,DAGRPID,Drug Accountability Group ID,A sponsor-defined identifier used to tie a block of related records in a single domain.,What is the test group identifier?,Test Group Identifier,Char,O,Record unique group identifier. Sponsor may insert additional instructions to ensure each record has a unique group identifier.,DAGRPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,It can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This group identifier ties together all the tests collected on this horizontal record. This field may be populated by the sponsor's data collection system.,6
Findings,DA,N/A,Horizontal-Generic,7,[DATESTCD]_DAPERF,Drug Accountability Performed,An indication of whether a planned drug accountability assessment was performed.,Was [DATEST] collected?,[DATEST] Collected,Char,O,Indicate whether or not drug accountability was performed.,DASTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable DASTAT. If DAPERF=""N"", the value of DASTAT will be ""NOT DONE"". If DAPERF=""Y"", DASTAT should be null. A combination of SDTMIG variables ( e.g., DACAT and DASCAT, DATPT) is used to indicate that multiple tests were not done. In this situation, the SDTM variable DATESTCD would be populated as DAALL and an appropriate test name (DATEST) provided. See SDTMIG for additional information.",(NY),N/A,"This general prompt question is used as a data management tool to verify that missing results are confirmed missing. This may be implemented for all tests collected on the same horizontal record or for each specific test. When mapped to SDTM, the value of DAPERF would apply to all tests on the same record. Use the CDASH variable [DATESTCD]_DAPERF when implemented on a specific test basis. This is an example of the type of CDASH variable names that can be used in a denormalized data structure.",7
Findings,DA,N/A,Horizontal-Generic,8,[DATESTCD]_DACAT,DA Category of Assessment,A grouping of topic-variable values based on user-defined characteristics.,What was the type of treatment for which drug accountability was assessed?,Treatment Type,Char,O,"Record the type of study treatment for which drug accountability is assessed (e.g., STUDY MEDICATION, RESCUE MEDICATION, COMPARATOR, PLACEBO).",DACAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. If the protocol allows dispensing different types of study treatment (e.g., study medication, rescue medication, run-in medication) the CRF can capture the type of treatment using DACAT. This may be pre-printed on the CRF. If DACAT is not collected (e.g., it is evident from the protocol design), it could be populated during the SDTM-based dataset creation process. The value of DACAT would apply to all measurements on that record when mapped to SDTM. If needed, the CDASH variable [DATESTCD]_DACAT may be used to collect a category for each DATEST. See SDTMIG for examples on populating DACAT and DASCAT. This is an example of the type of CDASH variable names that can be used in a denormalized data structure.",8
Findings,DA,N/A,Horizontal-Generic,9,[DATESTCD]_DASCAT,DA Subcategory of Assessment,A sub-division of the DACAT values based on user-defined characteristics.,What was the name of the treatment for which drug accountability was assessed?,[DATEST] Treatment Name,Char,O,"Record the name of the study treatment dispensed (e.g., DRUG A, DRUG B, BOTTLE 1).",DASCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a category value pre-printed on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column header. If known at the time of data collection, the treatment name may be collected in DASCAT (with appropriate grouping values, but different from those for DACAT). The value of DASCAT would apply to all measurements on that record when mapped to SDTM. If needed, the CDASH variable [DATESTCD]_DASCAT may be used to collect a category for each DATEST. See SDTMIG for examples on populating DACAT and DASCAT. DASCAT can only be used if there is an DACAT, and it must be a subcategorization of DACAT.",9
Findings,DA,N/A,Horizontal-Generic,10,[DATESTCD]_DAREFID,Drug Accountability Reference ID,"An internal or external identifier such as treatment label identifier (e.g., kit number, bottle label, vial identifier).",What is the [DATEST] treatment label identifier?,[DSTEST] Treatment Label Identifier,Char,O,Record dispensed treatment label identifier.,DAREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in EX domain.,N/A,N/A,"The packaging identifier (e.g., kit number, bottle label, vial identifier) may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some study dosing regimens, greater granularity for treatment identifiers may be needed. In this situation, sponsors may need to use additional variables. This is an example of the type of CDASH variable names that can be used in a denormalized data structure.",10
Findings,DA,N/A,Horizontal-Generic,11,[DATESTCD]_DADAT,Drug Accountability Date of Assessment,"The date the study treatment was dispensed or returned, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date [DATEST] drug accountability was assessed?,[DATEST] Date,Char,R/C,"Record the date drug accountability was performed, using this format (DD-MON-YYYY).",DADTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable DADTC in ISO 8601 format.",N/A,N/A,The date study treatment dispensed/returned should be recorded for each dispensation for a study with multiple periods or multiple products dispensed. A single date may be collected when all observations are performed on the same date. The date of each observation can also be collected using the CDASH variable [DATESTCD]_DADAT. The date of the observation may be determined from a collected date of visit and in such cases a separate measurement date field is not required. This is an example the type of CDASH variable names that can be used in a denormalized data structure.,11
Findings,DA,N/A,Horizontal-Generic,12,[DATESTCD]_DAORRES,DA Assessment Result in Original Units,"Result of the drug accountability assessment (e.g., actual amount).",What is the amount of the [DATEST] drug accountability assessment?,[DATEST] Amount,Char,HR,Record the result of the drug accountability assessment.,DAORRES; DATEST; DATESTCD,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. In addition to the SDTMIG variable DAORRES, create DATESTCD from the CDASH variable name and derive the value of DATEST from DATESTCD. The CDASH prompt may also contain DATEST. Use appropriate CDISC Controlled Terminology for the test and test code.",N/A,N/A,"Each test may be collected using the CDASH variable [TESTCD] (e.g., RETAMT) or [TESTCD]_DAORRES, where TESTCD is the appropriate CT for the DA test code (e.g., RETAMT_DAORRES). For a study with multiple periods or multiple products dispensed, drug accountability amounts should be assessed for each dispensation and return. For the SDTM submission dataset, DAREFID should be used to link related records. This is an example of the types of CDASH variable names that can be used in a denormalized data structure.",12
Findings,DA,N/A,Horizontal-Generic,13,[DATESTCD]_DAORRESU,DA Original Units,The unit of the result as originally received or collected.,What was the unit of the [DATEST] result?,[DATEST] Unit,Char,HR,"Record or select the original units in which these data were collected, if not pre-printed on CRF.",DAORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),(DAORRESU),The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. This is an example of the types of CDASH variable names that can be used in a denormalized data structure.,13
Findings,DA,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",14
Findings,DA,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",15
Findings,DA,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What is the subject identifier?,Subject,Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",16
Findings,DA,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",17
Findings,DA,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable DADTC in ISO 8601 format.",N/A,N/A,"The date the drug accountability assessments were collected can be determined from the Visit Date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the DA CRF using the date (DADAT) field.",18
Findings,DA,N/A,N/A,6,DAPERF,Drug Accountability Performed,An indication of whether a planned drug accountability assessment was performed.,Was drug accountability performed?,Drug Accountability Performed,Char,O,Indicate whether or not drug accountability was performed.,DASTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable DASTAT. If DAPERF=""N"", the value of DASTAT will be ""NOT DONE"". If DAPERF=""Y"", DASTAT should be null. A combination of SDTMIG variables ( e.g., DACAT and DASCAT, DATPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable DATESTCD would be populated as DAALL and an appropriate test name (DATEST) provided. See SDTMIG for additional information.",(NY),N/A,This may be implemented on a CRF page level on a visit-by-visit basis. This general prompt question is used as a data management tool to verify that missing results are confirmed missing.,19
Findings,DA,N/A,N/A,7,DACAT,DA Category of Assessment,A grouping of topic-variable values based on user-defined characteristics.,What was the type of treatment for which drug accountability was assessed?,[Treatment Type]; NULL,Char,O,Record the type of treatment dispensed/returned.,DACAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. If the protocol allows dispensing different types of treatment (e.g., study medication, rescue medication, run-in medication) the CRF can capture the type of treatment using DACAT. This may be pre-printed on the CRF. If DACAT is not collected (e.g., it is self-evident from the protocol design), it can be populated during the SDTM-based dataset creation process. See SDTMIG DA domain examples for populating DACAT and DASCAT.",20
Findings,DA,N/A,N/A,8,DASCAT,DA Subcategory of Assessment,A sub-division of the DACAT values based on user-defined characteristics.,What was the name of the treatment for which drug accountability was assessed?,[Treatment Name]; NULL,Char,O,"Record the name of the study treatment dispensed/returned (e.g., Bottle A, Bottle B).",DASCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. If known at the time of data collection, the treatment name may be collected in DASCAT (with appropriate grouping values, but different from those for DACAT). See SDTMIG DA domain examples for populating DACAT and DASCAT. DASCAT can only be used if there is an DACAT, and it must be a subcategorization of DACAT.",21
Findings,DA,N/A,N/A,9,DADAT,Drug Accountability Date,"The date the study treatment was dispensed or returned, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the drug accountability assessment was performed?,Date,Char,R/C,"Record the exact date the study treatment was (dispensed or returned), using this format (DD-MON-YYYY).",DADTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable DADTC in ISO 8601 format.",N/A,N/A,The date study treatment dispensed/returned should be recorded for each dispensation for a study with multiple periods or multiple products dispensed.,22
Findings,DA,N/A,N/A,10,DAREFID,Drug Accountability Reference ID,"An internal or external identifier such as treatment label identifier (e.g., kit number, bottle label, vial identifier).",What was the treatment label identifier?,Treatment Label Identifier,Char,O,Record treatment label identifier.,DAREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"For the SDTM submission dataset, DAREFID should be used to tie together a block of related records and to link dispensed product to returned product. The packaging identifier (e.g., kit number, bottle label, vial identifier) may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some study dosing regimens, greater granularity for treatment identifiers may be needed. In this situation, sponsors may need to use additional identifier variables.",23
Findings,DA,N/A,N/A,11,DATEST,Name of Accountability Assessment,"Descriptive name of the measurement or finding (e.g., dispensed, returned).",What was the drug accountability being assessed?,[Drug Accountability Test Name],Char,HR,"Record the name of the drug accountability assessment if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",DATEST; DATESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable DATESTCD may be determined from the value collected in the CDASH field DATEST. The SDTMIG variables DATESTCD and DATEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(DATEST),N/A,"Required to identify which test the result is for. It is recommended that the test names pre-printed on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as ""Test"" can be included as the column heading. For a study with multiple periods or multiple products dispensed, drug accountability amounts should be assessed for each dispensation.",24
Findings,DA,N/A,N/A,12,DAORRES,DA Assessment Result in Original Units,"Result of the drug accountability assessment as originally dispensed or returned (e.g., actual amount).",What is the result of the drug accountability assessment?,Amount,Char,HR,Record the actual amount of treatment dispensed or returned.,DAORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"For a study with multiple periods or multiple products dispensed, drug accountability amounts should be assessed for each dispensation.",25
Findings,DA,N/A,N/A,13,DAORRESU,DA Original Units,The unit of the result as originally received or collected.,What was the unit?,Unit,Char,HR,"Record or select the original units in which these data were collected, if not pre-printed on CRF.",DAORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),(DAORRESU),"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.",26
Findings,DD,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,DD,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be prepopulated.",2
Findings,DD,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,DD,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,DD,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable DDDTC in ISO 8601 format.",N/A,N/A,The date the death details assessments were reported can be determined from the Visit Date variable (VISDAT) and applying that date to all of the observations at that visit or the collection date can be included on the Death Detail CRF using the date (DDDAT) field.,5
Findings,DD,N/A,N/A,6,DDCAT,Category for Death Details,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the death detail assessment?,[Death Detail Category]; NULL,Char,O,"Record the death detail category, if not pre-printed on the CRF.",DDCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer.,6
Findings,DD,N/A,N/A,7,DDSCAT,Subcategory for Death Details,A sub-division of the DDCAT values based on user-defined characteristics.,What is the subcategory of the death detail assessment?,[Death Detail Assessment Subcategory]; NULL,Char,O,"Record the death detail subcategory, if not pre-printed on the CRF.",DDSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a category value pre-printed on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column header DDSCAT can only be used if there is an DDCAT, and it must be a subcategorization of DDCAT.",7
Findings,DD,N/A,N/A,8,DDYN,Any Death Detail Results,General prompt to establish whether any death details are available.,Were any death detail assessments collected?,Any Death Details,Char,O,"Indicate if the death details are known. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,8
Findings,DD,N/A,N/A,9,DDDAT,Death Details Date of Collection,"The date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date death detail assessments were collected?,Collection Date,Char,R/C,Record the date of collection using this format (DD-MON-YYYY).,DDDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable DDDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",9
Findings,DD,N/A,N/A,10,DDSPID,Death Details Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.",DDSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",10
Findings,DD,N/A,N/A,11,DTHDAT,Death Date,Date of death for any subject who died.,What was the subject's date of death?,Death Date,Char,O,Record the date of death.,DM.DTHDTC,"This field does not map directly to an SDTMIG variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DTHDTC in ISO 8601 format.",N/A,N/A,"The CDASH model defines Death Date as a timing variable; this is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the sponsor, but should only be collected once. The SDTMIG variable DTHDTC is mapped to the DM domain during the SDTM submission dataset creation process. The SDTMIG variable DM.DTHFLG is not a CDASH variable, but it is typically populated during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains (e.g., DS), as deemed appropriate by the sponsor.",11
Findings,DD,N/A,N/A,12,DDTEST,Death Detail Assessment Name,Descriptive name for death details.,What was the death detail assessment test name?,[Death Detail Assessment (Test Name],Char,HR,"Record the name of the death detail assessment, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",DDTEST; DDTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable DDTESTCD may be determined from the value collected in DDTEST. Both DDTESTCD and DDTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(DTHDX),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included as the column header.",12
Findings,DD,N/A,N/A,13,DDORRES,Death Details Result or Finding,"Result of the death detail assessment, as originally received or collected.",What was the result of the death detail assessment?,(Result),Char,HR,Record the death detail response.,DDORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,N/A,13
Findings,DD,N/A,N/A,14,DDEVAL,Death Details Evaluator,The role of the person who provided the information.,Who provided the death detail assessment information?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",DDEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed, or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",14
Findings,DD,N/A,Horizontal-Generic,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",15
Findings,DD,N/A,Horizontal-Generic,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be prepopulated.",16
Findings,DD,N/A,Horizontal-Generic,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",17
Findings,DD,N/A,Horizontal-Generic,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",18
Findings,DD,N/A,Horizontal-Generic,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY format).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable DDDTC in ISO 8601 format.",N/A,N/A,The date the death details assessments were reported can be determined from the Visit Date variable (VISDAT) and applying that date to all of the observations at that visit or the collection date can be included on the Death Detail CRF using the date (DDDAT) field.,19
Findings,DD,N/A,Horizontal-Generic,6,DDYN,Any Death Detail Results,General prompt to establish whether any death details are available,Were any death detail assessments collected?,Any Death Detail Assessments,Char,O,"Indicate if the death details are known. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification if all other fields on the CRF were deliberately left blank.,20
Findings,DD,N/A,Horizontal-Generic,7,DDCAT,Category for Death Details,A grouping of topic-variable values based on user defined characteristics,What is the category of the death detail assessment?,[Death Detail Assessment Category]; NULL,Char,O,"Record the death detail category, if not pre-printed on the CRF",DDCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a category value pre-printed on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",21
Findings,DD,N/A,Horizontal-Generic,8,DDSCAT,Subcategory for Death Details,A sub-division of the DDCAT values based on user defined characteristics,What is the subcategory of the death detail assessment?,[Death Detail Assessment Subcategory]; NULL,Char,O,"Record the death detail subcategory, if not pre-printed on the CRF.",DDSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a category value pre-printed on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column header DDSCAT can only be used if there is an DDCAT, and it must be a subcategorization of DDCAT.",22
Findings,DD,N/A,Horizontal-Generic,9,[DTHDXCD]_DDDAT,Death Details Date of Collection,"The date of collection represented in an unambiguous date format (e.g., DD-MON-YYYY)",What was the date [DTHDX] assessment was collected?,[DTHDX] Date,Char,R/C,Record the date of collection using this format (DD-MON-YYYY).,DDDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable DDDTC in ISO 8601 format.",N/A,N/A,A single date may be collected for all death detail assessments when they are collected on the same date. The date of collection of each assessment can also be collected using a CDASH variable [DTHDXCD]_DDDAT. The date of the assessment may be determined from a collected date of visit and in such cases a separate assessment date field is not required.,23
Findings,DD,N/A,Horizontal-Generic,10,DTHDAT,Date of Death,Date of death for any subject who died,What was the subject's date of death?,Death Date,Char,O,Record the date of death.,DM.DTHDTC,"This field does not map directly to an SDTMIG variable. For the SDTM dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable DTHDTC in ISO 8601 format.",N/A,N/A,"The CDASH model defines Death Date as a timing variable; this is not included as a timing variable in the SDTMIG. It may be collected on any CRF deemed appropriate by the sponsor, but should only be collected once. The SDTMIG variable DTHDTC is mapped to the DM domain during the SDTM submission dataset creation process. The SDTMIG variable DM.DTHFLG is not a CDASH variable, but it is typically populated during the SDTM submission dataset creation process. Death Date may be mapped to other SDTM domains (e.g., DS), as deemed appropriate by the sponsor.",24
Findings,DD,N/A,Horizontal-Generic,11,[DTHDXCD]_DDORRES,Death Details Result or Finding,"Result of the death detail assessment, as originally received or collected",What was the death detail assessment result?,Result,Char,HR,Record the death detail response.,DDORRES; DDTEST; DDTESTCD,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. In addition to the SDTMIG variable DDORRES, create DDTESTCD from the CDASH variable name and determine the value of DDTEST from DDTESTCD. The CDASH prompt may also contain the DDTEST. Use appropriate CDISC Controlled Terminology for the test and test code.",N/A,N/A,"Each test may be collected using the CDASH variable [TESTCD] (e.g., PRCDTH) or [TESTCD]_DDORRES where TESTCD is the appropriate CT for the DD test code e.g., PRCDTH_DDORRES. This variable name is an example of the types of CDASH variable names that can be used in a denormalized data structure.",25
Findings,DD,N/A,Horizontal-Generic,12,DDEVAL,Death Details Evaluator,The role of the person who provided the information,Who provided the death detail assessment information?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",DDEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",26
Findings,EG,Central Reading,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,EG,Central Reading,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,EG,Central Reading,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,EG,Central Reading,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,EG,Central Reading,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,"The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field.",5
Findings,EG,Central Reading,N/A,6,EGCAT,Category for ECG,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the ECG finding?,[ECG Category]; NULL,Char,O,"Record the ECG finding category, if not pre-printed on the CRF.",EGCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column header.",6
Findings,EG,Central Reading,N/A,7,EGSCAT,Subcategory for ECG,A sub-division of the EGCAT values based on user-defined characteristics.,What was the subcategory of the ECG finding?,[ECG Subcategory]; NULL,Char,O,"Record the ECG finding subcategory, if not pre-printed on the CRF.",EGSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column header EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT.",7
Findings,EG,Central Reading,N/A,8,EGPERF,ECG Performed,"An indication of whether a planned ECG measurement, series of ECG measurements, tests, or observations was performed.",Was the ECG performed?,ECG Performed,Char,HR,Indicate whether or not an ECG or specific ECG test was done.,EGSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable EGSTAT. If the CDASH field EGPERF= "N", the value of EGSTAT will be "NOT DONE". If EGPERF = "Y", EGSTAT should be null. A combination of SDTMIG variables (e.g., EGCAT and EGSCAT, EGTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",8
Findings,EG,Central Reading,N/A,9,EGREPNUM,ECG Repetition Number,"The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample).",Which repetition of the ECG is this?,Repetition number,Num,O,Record which repetition of the ECG this is.,EGREPNUM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"If there are multiple ECGs, this is used to record in which order this ECG occurred.",9
Findings,EG,Central Reading,N/A,10,EGREFID,ECG Reference ID,"An internal or external identifier of the ECG (e.g., waveform number).",What was the (ECG) [reference identifier/accession number]?,(ECG) [Reference Identifier/Accession Number],Char,O,Record the identifier number assigned.,EGREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer if this reference ID happens to be available to the site at the time of collection. It can also be used to link the clinical significance assessment to the proper record in the electronic data. (e.g., UUID for external waveform file, session number automatically generated by electronic equipment).",10
Findings,EG,Central Reading,N/A,11,EGMETHOD,Method of ECG Test,Method of the test or examination.,What was the method used for the ECG?,Method,Char,O,Record the method used for the ECG.,EGMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EGMETHOD),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One possible condition is the method used to collect or calculate the ECG data. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF: \n * Method of ECG is provided as part of the electronic data. \n * Method of ECG is not pertinent to the protocol. \n * The protocol specifies only 1 possible method for collecting ECG measurements and the sponsor does not feel there is significant risk of the sites performing the ECG using the incorrect method.",11
Findings,EG,Central Reading,N/A,12,EGLEAD,ECG Lead Location Used for Measurement,"The lead used for the measurement (e.g., "LEAD I", "LEAD II", "LEAD III", "LEAD rV2", "LEAD V1")",Which lead location was used for this measurement?,Lead Location,Char,O,Record which lead was used for this measurement.,EGLEAD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EGLEAD),N/A,This is used when more specificity for the location is desired for the ECG data.,12
Findings,EG,Central Reading,N/A,13,EGPOS,ECG Position of Subject,The position of the subject during the ECG measurement.,What was the position of the subject during the ECG measurement?,Position,Char,O,Record the position of the subject during the ECG.,EGPOS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(POSITION),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One common condition is the subject's position. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Position of the subject is provided as part of the electronic data.Position of the subject is not pertinent to the protocol.The protocol specifies only 1 possible position and the sponsor does not feel there is significant risk of the sites performing the ECG with the subject in the wrong position.",13
Findings,EG,Central Reading,N/A,14,EGDAT,ECG Date,"The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the ECG?,ECG Date,Char,R/C,Record the date the ECG was done using this format (DD-MON-YYYY).,EGDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",14
Findings,EG,Central Reading,N/A,15,EGTPT,ECG Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol.,What was the planned time point of the ECG measurement?,[Planned Time Point Name],Char,R/C,"Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF.",EGTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. SDTMIG time-point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as SDTMIG variables EGTPTNUM, EGELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included as the column header.",15
Findings,EG,Central Reading,N/A,16,EGTIM,ECG Time,"Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time the ECG was collected?,ECG Time,Char,R/C,Record the time the ECG was done (as complete as possible).,EGDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis.,16
Findings,EG,Local Reading,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",17
Findings,EG,Local Reading,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",18
Findings,EG,Local Reading,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",19
Findings,EG,Local Reading,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",20
Findings,EG,Local Reading,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,"The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field.",21
Findings,EG,Local Reading,N/A,6,EGCAT,Category for ECG,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the ECG finding?,[ECG Category]; NULL,Char,O,"Record the ECG finding category, if not pre-printed on the CRF.",EGCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column header.",22
Findings,EG,Local Reading,N/A,7,EGSCAT,Subcategory for ECG,A sub-division of the EGCAT values based on user-defined characteristics.,What was the subcategory of the ECG finding?,[ECG Subcategory]; NULL,Char,O,"Record the ECG finding subcategory, if not pre-printed on the CRF.",EGSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column header EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT.",23
Findings,EG,Local Reading,N/A,8,EGPERF,ECG Performed,"An indication of whether a planned measurement, series of measurements, test, or observation was performed.",Was the ECG performed?,ECG Performed,Char,HR,Indicate whether or not ECG or specific ECG test was done.,EGSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable EGSTAT. If the CDASH field EGPERF="N", the value of EGSTAT will be "NOT DONE". If EGPERF="Y", EGSTAT should be null. A combination of SDTMIG variables ( e.g., EGCAT and EGSCAT, EGTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",24
Findings,EG,Local Reading,N/A,9,EGREPNUM,ECG Repetition Number,"The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample).",What repetition of the ECG is this?,Repetition Number,Num,O,Record which repetition of the ECG this is.,EGREPNUM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"If there are multiple ECGs, this is used to record in which order this ECG occurred.",25
Findings,EG,Local Reading,N/A,10,EGMETHOD,Method of ECG Test,Method of the test or examination.,What was the method used for the ECG?,Method,Char,O,Record the method used for the ECG.,EGMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EGMETHOD),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One possible condition is the method used to collect or calculate the ECG data. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Method of ECG is provided as part of the electronic data.Method of ECG is not pertinent to the protocol.The protocol specifies only 1 possible method for collecting ECG measurements and the sponsor does not feel there is significant risk of the sites performing the ECG using the incorrect method.",26
Findings,EG,Local Reading,N/A,11,EGLEAD,ECG Lead Location Used for Measurement,"The lead used for the measurement (e.g., "LEAD I", "LEAD II", "LEAD III", "LEAD rV2", "LEAD V1").",Which lead location was used for this measurement?,Lead Location,Char,O,Record which lead was used for this measurement.,EGLEAD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EGLEAD),N/A,This is used when more specificity for the location is desired for the ECG data.,27
Findings,EG,Local Reading,N/A,12,EGPOS,ECG Position of Subject,The position of the subject during the ECG measurement.,What was the position of the subject during the ECG measurement?,Position,Char,O,Record the position of the subject during the ECG.,EGPOS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(POSITION),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Position of the subject is provided as part of the electronic data.Position of the subject is not pertinent to the protocol.The protocol specifies only 1 possible position and the sponsor does not feel there is significant risk of the sites performing the ECG with the subject in the wrong position.",28
Findings,EG,Local Reading,N/A,13,EGDAT,Date of ECG,"The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the ECG?,ECG Date,Char,R/C,Record the date ECG was done using this format (DD-MON-YYYY).,EGDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required.",29
Findings,EG,Local Reading,N/A,14,EGTPT,ECG Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol.,What was the planned time point of the ECG measurement?,[Planned Time Point Name],Char,R/C,"Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF.",EGTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. SDTMIG time-point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as SDTMIG variables EGTPTNUM, EGELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included as the column heading.",30
Findings,EG,Local Reading,N/A,15,EGTIM,Time of ECG,"Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time the ECG was collected?,ECG Time,Char,R/C,Record the time the ECG was done (as complete as possible).,EGDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis.,31
Findings,EG,Local Reading,N/A,16,EGTEST,ECG Test or Examination Name,Descriptive name of the measurement or finding.,What was the ECG test name?,[ECG Test Name],Char,HR,"Record the name of the ECG measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",EGTEST; EGTESTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. The SDTMIG variable EGTESTCD may be determined from the value collected in EGTEST. The SDTMIG variables EGTESTCD and EGTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(EGTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Test" can be included as the column heading.",32
Findings,EG,Local Reading,N/A,17,EGORRES,ECG Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the ECG?,(Result),Char,HR,"Record test results, interpretations or findings.",EGORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,33
Findings,EG,Local Reading,N/A,18,EGORRESU,ECG Original Units,The unit of the result as originally received or collected.,What was the unit of the ECG results?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",EGORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),(EGORRESU),"May be included if quantitative results are recorded. Because units for quantitative ECG results are typically limited, units should be pre-printed on the CRF with the associated test when possible, rather than having sites record the units. This item is not necessary for qualitative results.",34
Findings,EG,Local Reading,N/A,19,EGCLSIG,ECG Clinical Significance,An indication of whether the ECG results were clinically significant.,Was the ECG clinically significant?,Clinically Significant,Char,O,Record whether ECG results were clinically significant.,SUPPEG.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEG dataset as the value of SUPPEG.QVAL where SUPPEG.QNAM ="EGCLSIG" and SUPPEG.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,Could apply to specific measurements or to overall interpretation.,35
Findings,EG,Central Reading with Investigator Assessment,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",36
Findings,EG,Central Reading with Investigator Assessment,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",37
Findings,EG,Central Reading with Investigator Assessment,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",38
Findings,EG,Central Reading with Investigator Assessment,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",39
Findings,EG,Central Reading with Investigator Assessment,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started),What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,"The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field.",40
Findings,EG,Central Reading with Investigator Assessment,N/A,6,EGCAT,Category for ECG,A grouping of topic-variable values based on user-defined characteristics,What was the category of the ECG finding?,[ECG Category]; NULL,Char,O,"Record the ECG finding category, if not on the CRF.",EGCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column heading.",41
Findings,EG,Central Reading with Investigator Assessment,N/A,7,EGSCAT,Subcategory for ECG,A sub-division of the EGCAT values based on user-defined characteristics,What was the subcategory of the ECG finding?,[ECG Subcategory]; NULL,Char,O,"Record the ECG finding subcategory, if not on the CRF.",EGSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column heading. EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT.",42
Findings,EG,Central Reading with Investigator Assessment,N/A,8,EGPERF,ECG Performed,"An indication of whether a planned measurement, series of measurements, test, or observation was performed",Was the ECG performed?,ECG Performed,Char,HR,Indicate whether or not an ECG or specific ECG test was done.,EGSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable EGSTAT. If the CDASH field EGPERF="N", the value of EGSTAT will be "NOT DONE". If EGPERF="Y", EGSTAT should be null. A combination of SDTMIG variables (e.g., EGCAT and EGSCAT, EGTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",43
Findings,EG,Central Reading with Investigator Assessment,N/A,9,EGREPNUM,ECG Repetition Number,"The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample).",Which repetition of the ECG is this?,Repetition Number,Num,O,Record which repetition of the ECG this is.,EGREPNUM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"If there are multiple ECGs, this is used to record in which order this ECG occurred.",44
Findings,EG,Central Reading with Investigator Assessment,N/A,10,EGREFID,ECG Reference ID,"An internal or external identifier of the ECG (e.g., waveform number)",What was the (ECG) [reference identifier/accession number]?,(ECG) [Reference Identifier/Accession Number],Char,O,Record the identifier number assigned.,EGREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer if this reference ID happens to be available to the site at the time of collection. Examples: Universally Unique Identifier (UUID) for external waveform file, session number automatically generated by electronic equipment. This can also be used to link.",45
Findings,EG,Central Reading with Investigator Assessment,N/A,11,EGMETHOD,Method of ECG Test,Method of the test or examination,What was the method used for the ECG?,Method,Char,O,Record the method used for the ECG.,EGMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EGMETHOD),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Method of ECG is provided as part of the electronic data.Method of ECG is not pertinent to the protocol.The protocol specifies only 1 possible method for collecting ECG measurements and the sponsor does not feel there is significant risk of the sites performing the ECG using the incorrect method.",46
Findings,EG,Central Reading with Investigator Assessment,N/A,12,EGLEAD,ECG Lead Location Used for Measurement,"The lead used for the measurement (e.g., "LEAD I", "LEAD II", "LEAD III", "LEAD rV2", "LEAD V1")",Which lead location was used for this measurement?,Lead Location,Char,O,Record which lead was used for this measurement.,EGLEAD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EGLEAD),N/A,This is used when more specificity for the location is desired for the ECG data.,47
Findings,EG,Central Reading with Investigator Assessment,N/A,13,EGPOS,ECG Position of Subject,The position of the subject during the ECG measurement,What was the position of the subject during the ECG measurement?,Position,Char,O,Record the position of the subject during the ECG.,EGPOS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(POSITION),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Position of the subject is provided as part of the electronic data.Position of the subject is not pertinent to the protocol.The protocol specifies only 1 possible position and the sponsor does not feel there is significant risk of the sites performing the ECG with the subject in the wrong position.",48
Findings,EG,Central Reading with Investigator Assessment,N/A,14,EGDAT,Date of ECG,"The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY)",What was the date of the ECG?,ECG Date,Char,R/C,Record the date ECG was done using this format (DD-MON-YYYY).,EGDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required.",49
Findings,EG,Central Reading with Investigator Assessment,N/A,15,EGTPT,ECG Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol,What was the planned time point of the ECG measurement?,[Planned Time Point Name],Char,R/C,"Record the time point labels for when the ECG test should be taken, if not on the CRF.",EGTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See SDTMIG for additional information on representing time points. SDTMIG time point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as SDTMIG variables EGTPTNUM, EGELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as "Planned Time Point" can be included as the column heading.",50
Findings,EG,Central Reading with Investigator Assessment,N/A,16,EGTIM,Time of ECG,"Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss)",What was the time the ECG was collected?,ECG Time,Char,R/C,Record the time the ECG was done (as complete as possible).,EGDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable EGDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis.,51
Findings,EG,Central Reading with Investigator Assessment,N/A,17,EGEVAL,ECG Evaluator,The role of the person who provided the evaluation,Who provided the information?; Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",EGEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",52
Findings,EG,Central Reading with Investigator Assessment,N/A,18,INTP_EGORRES,ECG Interpretation,Overall interpretation of the result of the measurement or finding,What was the interpretation of the ECG?,Interpretation,Char,O,Record overall interpretations of the ECG.,EGORRES,"This does not map directly to an SDTM variable. For the SDTM submission dataset, the recorded interpretation is populated into the SDTMIG variable EGORRES where EGTEST= "Interpretation", and EGTESTCD="INTP".",N/A,N/A,The overall interpretation of an ECG is mapped into the appropriate SDTM test and result variables. See the SDTMIG EG Domain for details.,53
Findings,EG,Central Reading with Investigator Assessment,N/A,19,EGCLSIG,ECG Clinical Significance \n,An indication of whether the ECG results were clinically significant,Was the ECG clinically significant?,Clinically Significant,Char,HR,Record whether ECG results were clinically significant.,SUPPEG.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPEG dataset as the value of SUPPEG.QVAL where SUPPEG.QNAM = "EGCLSIG" and SUPPEG.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,"Could apply to specific measurements or to overall interpretation. In this scenario, clinical significance could be provided by the investigator.",54
Findings,EG,Central Reading with Investigator Assessment,N/A,20,EGMHNO,Related Medical History Event ID,Identifier for the medical history event that was reported as a clinically significant ECG finding,What was the identifier for the medical history event that was reported as a clinically significant ECG finding?,Medical History Event Identifier,Char,O,Record the identifier for the medical history event that was reported as a clinically significant ECG finding.,N/A,"This does not map directly to an SDTMIG variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the MH domain.",N/A,N/A,Intent is to establish a link between the clinically significant ECG finding and the medical history event that was reported. EGMHNO can be used in RELREC to identify a relationship between records in EG dataset and records in the MH dataset. See the SDTMIG for information on creating RELREC.,55
Findings,EG,Central Reading with Investigator Assessment,N/A,21,EGAENO,Related Adverse Event ID,Identifier for the adverse event that was reported as a clinically significant ECG finding,What was the identifier for the adverse event(s) that was reported as a clinically significant ECG finding?,Adverse Event Identifier,Char,O,Record the identifier for the adverse event that was the reported as a clinically significant ECG finding.,N/A,"This does not map directly to an SDTMIG variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the AE domain.",N/A,N/A,Intent is to establish a link between the clinically significant ECG finding and the AE that was reported. EGAENO can be used to identify a relationship between records in EG dataset and records in the AE dataset. See the SDTMIG for information on creating RELREC.,56
Findings,IE,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,IE,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,IE,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,IE,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,IE,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using theis format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable IEDTC in ISO 8601 format.",N/A,N/A,The date the inclusion and exclusion assessments were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit or the collection date can be included on the Inclusion/Exclusion CRF using the date (IEDAT) field.,5
Findings,IE,N/A,N/A,6,IEYN,Any Incl/Excl Criteria Findings,Indication whether the subject met all the eligibility requirements for this study at the time the subject was enrolled.,Were all eligibility criteria met?,Met Criteria,Char,HR,Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if subject did not meet all criteria at the time the subject was enrolled.,N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification if all other fields on the CRF were deliberately left blank.,6
Findings,IE,N/A,N/A,7,IEDAT,Inclusion/Exclusion Collection Date,"The date of collection of the inclusion/exclusion criteria represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the eligibility criteria assessment was performed?,Date,Char,O,Record complete date when the eligibility assessment was performed using this format (DD-MON-YYYY).,IEDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable IEDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",7
Findings,IE,N/A,N/A,8,IECAT,Inclusion/Exclusion Category,A grouping category to denote whether the protocol entry criterion being assessed is inclusion criteria or exclusion criteria.,What was the category of the criterion?,Criterion Type,Char,R/C,Check the appropriate box to indicate whether the criterion exception was related to the subject's inclusion or exclusion.,IECAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(IECAT),N/A,These categories have been defined in SDTM and have controlled terminology that must be used. Only records for criteria that are not met appear in the IE SDTMIG domain. IECAT must be populated. This criterion category may be collected on the CRF in a tick/checkbox format or it may be included as part of the criterion identification and mapped when the SDTM submission datasets are created.,8
Findings,IE,N/A,N/A,9,IESCAT,Inclusion/Exclusion Subcategory,A sub-division of the IECAT values based on user-defined characteristics.,What was the subcategory of the criterion?,[Criterion Subtype]; NULL,Char,O,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",IESCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column heading. This can be used to distinguish criteria for a sub-study or to categorize the criterion as a major or minor exception.",9
Findings,IE,N/A,N/A,10,IETESTCD,Inclusion/Exclusion Criterion Short Name,The unique identifier associated with the criterion that was the exception.,What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?,Exception Criterion Identifier,Char,HR,"If the subject was not eligible, record the identifying code for each criterion that was an exception.",IETESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This field is required to appear on the CRF, but may be null if there are no exceptions to the inclusion/exclusion criteria. The CRF should allow multiple exceptions to be recorded. See SDTMIG for assumptions regarding protocol versioning. Sponsors may provide a list of inclusion/exclusion criteria and the unique identifying codes to the site. The list provided should be versioned/updated when the protocol changes and the criteria are changed. Sponsors should use sponsor-developed controlled terminology for IETESTCD.",10
Findings,IE,N/A,N/A,11,IETEST,Inclusion/Exclusion Criterion,Descriptive name of the inclusion or exclusion criterion that was the exception.,What was the description of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?,Exception Criterion Description,Char,O,"Record the description of the criterion, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",IETEST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable IETESTCD may be determined from the value collected in IETEST. The SDTMIG variables IETESTCD and IETEST are required in the SDTM submission datasets.,N/A,N/A,Sponsors could automatically populated the text in EDC systems when the criterion identifier is populated by the investigator. This can be verified by the PI to ensure the right exception identifier was selected.,11
Findings,IE,N/A,N/A,12,IEORRES,I/E Criterion Original Result,An indication of which inclusion criterion was not met or exclusion criterion was met.,What is the result?,(Result),Char,HR,"If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.",IEORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,(NY),"This is only a data collection field when a complete list of inclusion and exclusion criteria are included on the CRF with Yes/No response options. If the sponsor collects only the criteria that are not fulfilled, then, when an inclusion criterion is not met, IEORRES is mapped to ""N"" and when an exclusion criterion is met, IEORRES is mapped to ""Y"".",12
Findings,LB,Central Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,LB,Central Processing,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,LB,Central Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,LB,Central Processing,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,LB,Central Processing,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using DD-MON-YYYY format.,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,"The date the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the specimen collection date can be collected on the Laboratory CRF using the date (LBDAT) field.",5
Findings,LB,Central Processing,N/A,6,LBPERF,Lab Performed,"An indication of whether a planned lab measurement, series of lab measurements, tests, observations or was performed or specimens collected.",Was the sample collected?; Was the lab performed?,Lab Performed; Sample Collected,Char,HR,Indicate whether or not lab specimen was collected or measurement performed.,LBSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = ""N"", the value of LBSTAT will be ""NOT DONE"". If LBPERF = ""Y"", LBSTAT should be null. A combination of SDTMIG variables ( e.g., LBCAT and LBSCAT, LBTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire lab panel, or a specific lab test. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",6
Findings,LB,Central Processing,N/A,7,LBDAT,Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the lab specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date when specimen collection was done using this format (DD-MON-YYYY).,LBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. The SDTMIG LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",7
Findings,LB,Central Processing,N/A,8,LBTIM,Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the lab specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,LBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis or a specimen is collected over an extended time period.,8
Findings,LB,Central Processing,N/A,9,LBCAT,Category for Lab Test,A grouping of topic-variable values based on user-defined characteristics.,What was the name of the lab panel?,[Lab Panel Name]; NULL,Char,R/C,"Record the lab test category, if not pre-printed on the CRF.",LBCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category/subcategory (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).",9
Findings,LB,Central Processing,N/A,10,LBSCAT,Subcategory for Lab Test,A sub-division of the LBCAT values based on user-defined characteristics.,What was the name of the lab sub-panel?,[Lab Sub-Panel Name]; NULL,Char,R/C,"Record the lab test subcategory, if not pre-printed on the CRF.",LBSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology (e.g. electrolytes, liver function). This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.",10
Findings,LB,Central Processing,N/A,11,LBTPT,Lab Planned Time Point Name,"A text description of planned time point when measurements should be taken, as defined in the protocol.",What was the planned time point of the lab?,[Planned Time Point Name],Char,R/C,"Record the planned time point labels for the lab test, if not pre-printed on the CRF.",LBTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. SDTMIG time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as SDTMIG variables LBTPTNUM, LBELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",11
Findings,LB,Central Processing,N/A,12,LBCOND,Lab Test Condition Met,"Indication whether the testing conditions defined in the protocol were met (e.g., low-fat diet).",Were the protocol-defined testing conditions met?,Test Condition Met,Char,R/C,Record whether protocol defined testing conditions were met.,SUPPLB.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM ="LBCOND" and SUPPLB.LABEL="Test Condition Met". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,(NY),N/A,This information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF. This may not be relevant for all tests.,12
Findings,LB,Central Processing,N/A,13,LBFAST,Lab Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,R/C,Record whether the subject was fasting prior to the test being performed.,LBFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,13
Findings,LB,Central Processing,N/A,14,LBREFID,Lab Specimen ID,"An internal or external identifier (e.g., specimen identifier).",What was the (laboratory test) [reference identifier/accession number]?,(Laboratory) [Reference identifier/Accession Number],Char,R/C,Record the specimen or accession number assigned.,LBREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).",14
Findings,LB,Central Processing with CS,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",15
Findings,LB,Central Processing with CS,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",16
Findings,LB,Central Processing with CS,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",17
Findings,LB,Central Processing with CS,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",18
Findings,LB,Central Processing with CS,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using DD-MON-YYYY format.,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,"The date of the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the collection date can be collected on the Laboratory CRF using the date (LBDAT) field",19
Findings,LB,Central Processing with CS,N/A,6,LBPERF,Lab Performed,"An indication of whether a planned lab measurement, series of lab measurements, test, or observation was performed or specimens collected.",Was the sample collected?; Was the lab performed?,Lab Performed; Sample Collected,Char,HR,Indicate whether or not lab specimen was collected or measurement performed.,LBSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF=""N"", the value of LBSTAT will be ""NOT DONE"". If LBPERF=""Y"", LBSTAT should be null. A combination of SDTMIG variables (e.g., LBCAT and LBSCAT, LBTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire lab panel, or a specific lab test. This general prompt question is used as a data management tool to verify that missing results are confirmed missing.",20
Findings,LB,Central Processing with CS,N/A,7,LBDAT,Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the lab specimen collection,Specimen Collection (Start) Date,Char,R/C,Record the (start) date when the specimen collection was done using this format (DD-MON-YYYY).,LBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. The SDTMIG LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",21
Findings,LB,Central Processing with CS,N/A,8,LBTIM,Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the lab specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,LBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis or a specimen is collected over an extended time period.,22
Findings,LB,Central Processing with CS,N/A,9,LBCAT,Category for Lab Test,A grouping of topic-variable values based on user-defined characteristics.,What was the name of the lab panel?,[Lab Panel Name]; NULL,Char,R/C,"Record the lab test category, if not pre-printed on the CRF.",LBCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).",23
Findings,LB,Central Processing with CS,N/A,10,LBSCAT,Subcategory for Lab Test,A sub-division of the LBCAT values based on user-defined characteristics.,What was the name of the lab sub-panel?,[Lab Sub-Panel Name]; NULL,Char,R/C,"Record the lab test subcategory, if not pre-printed on the CRF.",LBSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology (e.g. electrolytes, liver function). This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.",24
Findings,LB,Central Processing with CS,N/A,11,LBTPT,Lab Planned Time Point Name,"A text description of planned time point when measurements should be taken, as defined in the protocol.",What was the planned time point of the lab?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for the lab test, if not pre-printed on the CRF.",LBTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. SDTMIG time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as SDTMIG variables LBTPTNUM, LBELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",25
Findings,LB,Central Processing with CS,N/A,12,LBCOND,Lab Test Condition Met,"Indication of whether the testing conditions defined in the protocol were met (e.g., low-fat diet).",Were the protocol-defined testing conditions met?,Test Condition Met,Char,O,Record whether protocol-defined testing conditions were met.,SUPPLB.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM ="LBCOND" and SUPPLB.LABEL="Test Condition Met". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,"This information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF (e.g., ""Did subject meet diet requirements?""). This may not be relevant for all tests.",26
Findings,LB,Central Processing with CS,N/A,13,LBFAST,Lab Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,R/C,Record whether the subject was fasting prior to the test being performed.,LBFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,27
Findings,LB,Central Processing with CS,N/A,14,LBTEST,Lab Test or Examination Name,Descriptive name of the lab test or examination used to obtain the measurement or finding. Any test normally performed by a clinical laboratory is considered a lab test.,What was the lab test name?,[Laboratory Test Name],Char,HR,"Record the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",LBTEST; LBTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable LBTESTCD may be determined from the value collected in LBTEST. The SDTMIG variables LBTESTCD and LBTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(LBTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included as the column heading.",28
Findings,LB,Central Processing with CS,N/A,15,LBORRES,Lab Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the lab test?,(Result),Char,HR,Record the laboratory test result.,LBORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Optional if already provided from central lab.,29
Findings,LB,Central Processing with CS,N/A,16,LBORRESU,Lab Original Units,The unit of the result as originally received or collected.,What was the unit of the lab result?,Unit,Char,O,Record or select the original unit in which these data were collected.,LBORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,Optional if already provided from central lab or a sponsor stores units separately.,30
Findings,LB,Central Processing with CS,N/A,17,LBCLSIG,Lab Clinical Significance,An indication whether lab test results were clinically significant.,Was this result clinically significant?,Clinically Significant,Char,HR,Record whether laboratory test results were clinically significant.,SUPPLB.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM ="LBCLSIG" and SUPPLB.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,Key data collected in this scenario.,31
Findings,LB,Central Processing with CS,N/A,18,LBREFID,Lab Specimen ID,"An internal or external identifier (e.g., specimen identifier).",What was the (laboratory test) [reference identifier/accession number]?,(Laboratory test) [Reference identifier/Accession Number],Char,R/C,Record the specimen or accession number assigned.,LBREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).",32
Findings,LB,Central Processing with CS,N/A,19,LBMETHOD,Lab Method of Test or Examination,Method of the test or examination.,What was the method used for the lab test or examination?,Method of Test or Examination,Char,O,Record the method of test or examination.,LBMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary.",33
Findings,LB,Local Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",34
Findings,LB,Local Processing,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",35
Findings,LB,Local Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",36
Findings,LB,Local Processing,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",37
Findings,LB,Local Processing,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,"The date of the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the collection date can be collected on the Laboratory CRF using the date (LBDAT) field.",38
Findings,LB,Local Processing,N/A,6,LBPERF,Lab Performed,"An indication of whether a planned lab measurement, series of lab measurements, test, or observation was performed or specimens collected.",Was the sample collected?; Was the lab performed?,Sample Collected; Lab Performed,Char,HR,Indicate whether or not lab specimen was collected or measurement performed.,LBSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable LBSTAT. If the CDASH variable LBPERF = ""N"", the value of LBSTAT will be ""NOT DONE"". If LBPERF = ""Y"", LBSTAT should be null. A combination of SDTMIG variables (e.g., LBCAT and LBSCAT, LBTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire panel, or on a specific test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",39
Findings,LB,Local Processing,N/A,7,LBDAT,Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the lab specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date of specimen collection using this format (DD-MON-YYYY).,LBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. The SDTMIG LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",40
Findings,LB,Local Processing,N/A,8,LBTIM,Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the lab specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible),LBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable LBDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis or a specimen is collected over an extended time period.,41
Findings,LB,Local Processing,N/A,9,LBCAT,Category for Lab Test,A grouping of topic-variable values based on user-defined characteristics.,What was the name of the lab panel?,[Lab Panel Name]; NULL,Char,R/C,"Record the lab test category, if not pre-printed on the CRF.",LBCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).",42
Findings,LB,Local Processing,N/A,10,LBSCAT,Subcategory for Lab Test,A sub-division of the LBCAT values based on user defined characteristics.,What was the name of the lab sub-panel?,[Lab Sub-Panel Name]; NULL,Char,R/C,"Record the lab test subcategory, if not pre-printed on the CRF.",LBSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.",43
Findings,LB,Local Processing,N/A,11,LBTPT,Lab Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol.,What was the planned time point of the lab?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for the lab test, if not pre-printed on the CRF.",LBTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. SDTMIG time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as SDTMIG variables LBTPTNUM, LBELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included as the column heading.",44
Findings,LB,Local Processing,N/A,12,LBFAST,Lab Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,R/C,Record whether the subject was fasting prior to the test being performed.,LBFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,45
Findings,LB,Local Processing,N/A,13,LBCOND,Lab Test Condition Met,"Indication of whether the testing conditions defined in the protocol were met (e.g., low-fat diet).",Were the protocol-defined testing conditions met?,Test Condition Met,Char,R/C,Record whether protocol-defined testing conditions were met.,SUPPLB.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM = "LBCOND" and SUPPLB.LABEL="Test Condition Met". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,"This information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF (e.g., ""Did subject meet diet requirements?""). This may not be relevant for all tests.",46
Findings,LB,Local Processing,N/A,14,LBSPCCND,Lab Specimen Condition,Description of the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,O,Record the condition of specimen.,LBSPCCND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECCOND),N/A,"May be collected using free or standardized text. Results may be affected by whether conditions for specimen were properly met. When local processing is used, sponsors may not routinely collect specimen condition.",47
Findings,LB,Local Processing,N/A,15,LBTEST,Lab Test or Examination Name,Descriptive name of the lab test or examination used to obtain the measurement or finding. Any test normally performed by a clinical laboratory is considered a lab test.,What was the lab test name?,[Laboratory Test Name],Char,HR,"Record the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",LBTEST; LBTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable LBTESTCD may be determined from the value collected in LBTEST. The SDTMIG variables LBTESTCD and LBTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(LBTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field that requires the site to enter text. If the form is laid out as a grid, then words such as ""Test"" can be included as the column heading.",48
Findings,LB,Local Processing,N/A,16,LBORRES,Lab Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the lab test?,(Result),Char,HR,Record the laboratory test result.,LBORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,49
Findings,LB,Local Processing,N/A,17,LBMETHOD,Lab Method of Test or Examination,Method of the test or examination.,What was the method used for the lab test or examination?,Method of [Test/Examination],Char,O,Record the method of test or examination.,LBMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary.",50
Findings,LB,Local Processing,N/A,18,LBORRESU,Lab Original Units,The unit of the result as originally received or collected.,What was the unit of the lab result?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",LBORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere. For some lab tests the units may not be applicable (e.g., urine color).",51
Findings,LB,Local Processing,N/A,19,LBCRESU,Lab Collected Non-Standard Unit,The unit of the result as originally received if it were collected as a non-standard unit.,What was the unit of the lab result?,Unit,Char,O,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",SUPPLB.QVAL,"This does not map directly to an SDTMIG variable. The collected, non-standard unit(s) may be submitted in a supplemental qualifier dataset.",N/A,N/A,"The collected, non-standard unit(s) should be reported as an equivalent standard unit in LBORRESU.",52
Findings,LB,Local Processing,N/A,20,LBTOXGR,Lab Standard Toxicity Grade,"The toxicity grade, using a standard toxicity scale (e.g., NCI CTCAE).",What is the toxicity grade?,Toxicity Grade,Char,O,Record the toxicity grade.,LBTOXGR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external code list attributes.,N/A,N/A,"This is commonly used in oncology trials but sponsors may not collect these toxicity grades on CRFs. Terminology codeslists (TOXGRV3, TOXGRV4) are available for use.",53
Findings,LB,Local Processing,N/A,21,LBTOX,Lab Toxicity,"A description of toxicity quantified by LBTOXGR (e.g., NCI CTCAE Short Name).",What is the description of the toxicity?,Toxicity,Char,O,Record the description of the toxicity.,LBTOX,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The sponsor is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external code list attributes.,N/A,N/A,"This would typically be the text description quantified by LBTOXGR (e.g., HYPERCALCEMIA, HYPOCALCEMIA)",54
Findings,LB,Local Processing,N/A,22,LBORNRLO,Lab Ref Range Lower Limit in Orig Unit,The lower end of normal range or reference range for continuous results stored in LBORRES.,What was the lower limit of the reference range for this lab test?,Normal Range Lower Limit,Char,R/C,Record the lower limit of the reference range of the lab test.,LBORNRLO,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be determined from a site or lab specific set of normal ranges stored in a look-up table. See the SDTMIG for details on mapping and selecting the proper variable name.,55
Findings,LB,Local Processing,N/A,23,LBORNRHI,Lab Ref Range Upper Limit in Orig Unit,The upper end of normal range or reference range for continuous results stored in LBORRES.,What was the high limit of the reference range for this lab test?,Normal Range Upper Limit,Char,R/C,Record the upper limit of the reference range of the lab test.,LBORNRHI,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be determined from a site or lab specific set of normal ranges stored in a look-up table. See the SDTMIG for details on mapping and selecting the proper variable name.,56
Findings,LB,Local Processing,N/A,24,LBNRIND,Lab Reference Range Indicator,An indication or description of how the value compares to the normal range or reference range.,How [did/do] the reported values compare within the [reference/normal/expected] range?,Comparison to [Reference/Expected/Normal] Range,Char,R/C,"Record where the lab result fell with respect to the reference range (e.g. HIGH, LOW, ABNORMAL).",LBNRIND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NRIND),N/A,"Reference ranges may be defined by LBORNRLO and LBORNRHI or other objective criteria. Typically for local processing, ""Reference Range Indicator"" may be derived or determined programmatically and is not collected on the CRF. Should not be used to indicate clinical significance.",57
Findings,LB,Local Processing,N/A,25,LBCLSIG,Lab Clinical Significance,An indication whether lab test results were clinically significant.,Was this result clinically significant?,Clinically Significant,Char,O,Record whether lab results were clinically significant.,SUPPLB.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPLB dataset as the value of SUPPLB.QVAL where SUPPLB.QNAM= "LBCLSIG" and SUPPLB.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,May be included if required by the protocol.,58
Findings,LB,Local Processing,N/A,26,LBNAM,Vendor Name,"The name or identifier of the vendor (e.g., laboratory) that provided the test results.",What was the name of the laboratory used?,Laboratory Name,Char,R/C,Record the laboratory name.,LBNAM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Recommended to collect on the CRF if lab name was not collected at the site/study level or if multiple labs are used by a site.,59
Findings,MB,Central Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during SDTM-based dataset creation before submission.",1
Findings,MB,Central Processing,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,MB,Central Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,MB,Central Processing,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,MB,Central Processing,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation or specimen collection date can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable MBDTC in ISO 8601 format.",N/A,N/A,"The date that the microbiology specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the microbiology findings at that visit, or the specimen collection date can be included on the Microbiology Findings CRF using the date (MBDAT) field.",5
Findings,MB,Central Processing,N/A,6,MBPERF,Microbiology Sampling Performed,"An indication of whether a planned measurement or series of measurements, tests, or observations was performed, or specimen was collected.",Was [specimen type] collected or [test topic] performed?,[Specimen/Sample] Collected; [Test topic] Performed,Char,O,"Indicate whether or not the planned measurement, series of measurements, tests, or observations was performed or specimen was collected. \n",MBSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable MBSTAT. If MBPERF = ""N"", the value of MBSTAT will be ""NOT DONE"". If MBPERF = ""Y"", MBSTAT should be null. A combination of SDTMIG variables (e.g., MBCAT and MBSCAT, MBTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable MBTESTCD would be populated as MBALL and an appropriate test name (MBTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire panel. General prompt question to be used as a data management tool to verify that missing results are confirmed missing. For the SDTM submission dataset, the SDTMIG variable MBSTAT is populated using the CDASH field MBPERF. The question text used might be reflected in the reason not done (MBREASND).",6
Findings,MB,Central Processing,N/A,7,MBREFID,MB Reference ID,An internal or external identifier such as specimen identifier.,What was the (microbiology test) [reference identifier/accession number]?,(Microbiology Test) [Reference Identifier/Accession Number],Char,O,Record the specimen [accession/reference] number assigned.,MBREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).",7
Findings,MB,Central Processing,N/A,8,MBGRPID,MB Group ID,A group identifier used to link together a block of related records within a subject in a domain.,What [is/was] the [test/procedure/observation] group identifier?,[Test/Procedure/Observation] Group Identifier,Char,O,"If collected on the CRF, the sponsor may insert instructions as to when it may be appropriate to group MB specimen records within a subject and how to indicate the specific MBGRPID.",MBGRPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Used to link together a block of related records within a subject. Should not be used to link detection records in MB to the associated susceptibility results in the MS domain. NHOID should be used to identify the non-host organism.,8
Findings,MB,Central Processing,N/A,9,MBDAT,MB Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the (microbiology) specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date when specimen collection occurred using this format (DD-MON-YYYY).,MBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MBDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required. The SDTMIG MBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",9
Findings,MB,Central Processing,N/A,10,MBTIM,MB Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the (microbiology) specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,MBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MBDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis.,10
Findings,MB,Central Processing,N/A,11,MBCAT,MB Category for Microbiology Finding,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the microbiology finding?,[Microbiology Category]; NULL,Char,O,"Record the microbiology finding category, if not pre-pre-printed on the CRF.",MBCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading.",11
Findings,MB,Central Processing,N/A,12,MBSCAT,MB Subcategory for Microbiology Finding,A sub-division of the MBCAT values based on user-defined characteristics.,What was the subcategory of the microbiology finding?,[Microbiology Subcategory]; NULL,Char,O,"Record the microbiology finding subcategory, if not pre-printed on the CRF.",MBSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column heading. MBSCAT can only be used if there is an MBCAT, and it must be a subcategorization of MBCAT.",12
Findings,MB,Central Processing,N/A,13,MBSPEC,MB Specimen Type,The type of sample material taken from a biological entity.,What is the specimen material type?,Specimen Type,Char,R/C,Record the specimen material type.,MBSPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",13
Findings,MB,Central Processing,N/A,14,MBSPCCND,MB Specimen Condition,Description of the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,R/C,Record condition of specimen.,MBSPCCND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECCOND),N/A,May be collected using free or standardized text. This can be used when results may be affected by whether conditions for specimen were properly met.,14
Findings,MB,Central Processing,N/A,15,MBLOC,MB Specimen Collection Location,A description of the anatomical location of the subject relevant to the collection of specimen.,What was the anatomical location where the specimen was collected?,Anatomical Location,Char,O,Record or select the anatomical location of specimen collection.,MBLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, PORTOT are used to further describe the anatomical location.",15
Findings,MB,Central Processing,N/A,16,MBLAT,MB Specimen Collection Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the specimen collection?,Side,Char,O,Record the side of the anatomical location of the specimen collection.,MBLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,16
Findings,MB,Central Processing,N/A,17,MBDIR,MB Specimen Collection Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the specimen collection?,Directionality,Char,O,Record the directionality of the anatomical location of the specimen collection.,MBDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,17
Findings,MB,Local Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",18
Findings,MB,Local Processing,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",19
Findings,MB,Local Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",20
Findings,MB,Local Processing,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",21
Findings,MB,Local Processing,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using the format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation or specimen collection date can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable MBDTC in ISO 8601 format.",N/A,N/A,"The date that the microbiology specimens were collected can be determined from from the visit date variable (VISDAT) and applying that date to all of the microbiology findings at that visit, or the specimen collection date can be included on the Microbiology Findings CRF using the date (MBDAT) field.",22
Findings,MB,Local Processing,N/A,6,MBPERF,Microbiology Sampling Performed,"An indication of whether a planned measurement or series of measurements, test, or observations was performed, or specimen was collected.",Was the microbiology examination performed?,Microbiology Examination Performed,Char,O,Indicate whether or not microbiology examination was performed.,MBSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable MBSTAT. If MBPERF=""N"", the value of MBSTAT will be ""NOT DONE"". If MBPERF=""Y"", MBSTAT should be null. A combination of SDTMIG variables (e.g., MBCAT and MBSCAT, MBTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable MBTESTCD would be populated as MBALL and an appropriate test name (MBTEST) provided. See the SDTMIG.",(NY),N/A,This may be implemented for an entire panel. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.,23
Findings,MB,Local Processing,N/A,7,MBREFID,MB Reference ID,"An internal or external identifier (e.g., specimen identifier).",What was the (microbiology test) [reference identifier/accession number]?,(Microbiology Test) [Reference identifier/Accession Number],Char,O,Record the specimen [accession/reference] number assigned.,MBREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).",24
Findings,MB,Local Processing,N/A,8,MBSPID,MB Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",MBSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",25
Findings,MB,Local Processing,N/A,9,MBGRPID,MB Group ID,A group identifier used to link together a block of related records within a subject in a domain.,What [is/was] the [test/procedure/observation] group identifier?,[Test/Procedure/Observation] Group Identifier,Char,O,"If collected on the CRF, the sponsor may insert instructions as to where it may be appropriate to group MB specimen records within a subject and how to indicate a specific MBGRPID..",MBGRPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Used to link together a block of related records within a subject. Should not be used to link detection records in MB to the associated susceptibility results in the MS domain. NHOID should be used to identify the non-host organism.,26
Findings,MB,Local Processing,N/A,10,MBLNKID,MB Link ID,An identifier used to link related records across domains.,What [is/was] the [test/procedure/observation] link identifier?,[Domain/Observation] Link Identifier,Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each microbiology specimen or result record has a unique identifier that will link records across domains.",MBLNKID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,This may be a one-to-one or a one-to-many relationship. May be used to link to susceptibility records (in MS) if needed.,27
Findings,MB,Local Processing,N/A,11,MBDAT,MB Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the (microbiology) specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date of specimen collection using this format (DD-MON-YYYY).,MBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MBDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",28
Findings,MB,Local Processing,N/A,12,MBTIM,MB Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the (microbiology) specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,MBDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MBDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.,29
Findings,MB,Local Processing,N/A,13,MBCAT,MB Category for Microbiology Finding,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the microbiology finding?,[Microbiology Category]; NULL,Char,O,"Record the microbiology finding category, if not pre-printed on the CRF.",MBCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading.",30
Findings,MB,Local Processing,N/A,14,MBSCAT,MB Subcategory for Microbiology Finding,A sub-division of the MBCAT values based on user-defined characteristics.,What was the subcategory of the microbiology finding?,[Microbiology Subcategory]; NULL,Char,O,"Record the microbiology finding subcategory, if not pre-printed on the CRF.",MBSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column heading. MBSCAT can only be used if there is an MBCAT, and it must be a subcategorization of MBCAT.",31
Findings,MB,Local Processing,N/A,15,MBTEST,Microbiology Test or Finding Name,Descriptive name of the microbiology test or examination used to obtain the measurement or finding.,What was the microbiology examination test name?,[Microbiology Test Name],Char,HR,"Record the type or name of the microbiology examination, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",MBTEST; MBTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable MBTESTCD may be determined from the value collected in MBTEST. Both MBTESTCD and MBTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(MBTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included as the column heading.",32
Findings,MB,Local Processing,N/A,16,MBTSTDTL,Microbiology Examination Detail,Detail of the microbiology examination used to obtain the measurement or finding.,What was the microbiology examination detail?,[Examination Name Detail],Char,O,"Record the detail of the microbiology examination, if not pre-printed on the CRF.",MBTSTDTL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Provides additional details for the microbiology examination. It is recommended that the test detail be pre-printed on the CRF. If the form is laid out as a grid, then words such as ""Test Detail"" can be included as the column heading.",33
Findings,MB,Local Processing,N/A,17,MBORRES,MB Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the examination?,(Result),Char,HR,"Record test result, interpretation, or finding.",MBORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,34
Findings,MB,Local Processing,N/A,18,MBORRESU,MB Original Units,The unit of the result as originally received or collected.,What was the unit of the result?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",MBORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere. For some tests the units may not be applicable (e.g., where MBTEST=""Microbial Organism Identification"").",35
Findings,MB,Local Processing,N/A,19,MBCLSIG,MB Clinical Significance,An indication of whether the test results were clinically significant.,Was the result clinically significant?,Clinically Significant,Char,O,Indicate whether the results were clinically significant.,SUPPMB.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPMB dataset as the value of SUPPMB.QVAL where SUPPMB.QNAM = "MBCLSIG" and SUPPMB.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,N/A,36
Findings,MB,Local Processing,N/A,20,MBRESCAT,MB Result Category,Used to categorize the result of a finding.,What was the result category?,Result Category,Char,O,Record the category of the test results.,MBRESCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Used to categorize the results of a finding (e.g., INFECTING, COLONIZER).",37
Findings,MB,Local Processing,N/A,21,MBNAM,MB Vendor Name,"The name or identifier of the vendor (e.g., laboratory) that provided the test results.",What was the name of the vendor used?,Vendor Name,Char,O,Record the laboratory name.,MBNAM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Recommended to collect on the CRF if the vendor name was not collected at the site/study level or if multiple vendors are used by a site.,38
Findings,MB,Local Processing,N/A,22,MBSPEC,MB Specimen Type,The type of specimen used for a measurement.,What is the specimen material type?,Specimen Type,Char,O,Record the specimen material type.,MBSPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",39
Findings,MB,Local Processing,N/A,23,MBSPCCND,MB Specimen Condition,Describes the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,O,Record the condition of specimen.,MBSPCCND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECCOND),N/A,May be collected using free or standardized text. This can be used when results may be affected by whether conditions for specimen were properly met.,40
Findings,MB,Local Processing,N/A,24,MBLOC,MB Specimen Collection Location,"A description of the anatomical location, relevant to the collection of specimen.",What was the anatomical location where the specimen was collected?,Anatomical Location,Char,O,Record or select the anatomical location of specimen collection.,MBLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",41
Findings,MB,Local Processing,N/A,25,MBLAT,MB Specimen Collection Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the specimen collection?,Side,Char,O,Record the side of the anatomical location of the specimen collection.,MBLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,42
Findings,MB,Local Processing,N/A,26,MBDIR,MB Specimen Collection Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the specimen collection?,Directionality,Char,O,Record the directionality of the anatomical location of the specimen collection.,MBDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,43
Findings,MB,Local Processing,N/A,27,MBMETHOD,MB Method of Test or Examination,Method of the test or examination.,What was the method used for the test or examination?,Method,Char,O,Record the method of test or examination.,MBMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary. This could include technique or type of staining used for the slides.",44
Findings,MB,Local Processing,N/A,28,MBEVAL,MB Evaluator,The role of the person who provided the evaluation.,Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",MBEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",45
Findings,MS,Central Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,MS,Central Processing,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,MS,Central Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,MS,Central Processing,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,MS,Central Processing,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable MIDTC in ISO 8601 format.",N/A,N/A,"The date the microbiology specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the microbiology susceptibility findings at that visit, or the specimen collection date can be included on the MS CRF using the date (MSDAT) field.",5
Findings,MS,Central Processing,N/A,6,MSPERF,MS Test Performed,"An indication of whether a planned measurement, series of measurements, tests or observations was performed.",Was the Microbiology Susceptibility test performed?,Microbiology Susceptibility Performed,Char,O,Indicate whether or not a microbiology susceptibility test was performed.,MSSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable MSSTAT. If MSPERF=""N"", the value of MSSTAT will be ""NOT DONE"". If MSPERF=""Y"", MSSTAT should be null. A combination of SDTMIG variables (e.g., MSCAT and MSSCAT, MSTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable MSTESTCD would be populated as MSALL and an appropriate test name (MSTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire panel. General prompt question to be used as a data management tool to verify that missing results are confirmed missing. For the SDTM submission dataset, the SDTMIG variable MSSTAT is populated using the CDASH field MSPERF. The question text used might be reflected in the reason not done (MSREASND).",6
Findings,MS,Central Processing,N/A,7,MSREFID,MS Reference ID,"An internal or external identifier, such as specimen identifier.",What was the (microbiology susceptibility test) [reference identifier/accession number]?,(Microbiology Susceptibility Test) [Reference Identifier/Accession Number],Char,O,Record the specimen [accession/reference] number assigned.,MSREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).",7
Findings,MS,Central Processing,N/A,8,MSDAT,MS Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the (microbiology) specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date when specimen collection occurred using this format (DD-MON-YYYY).,MSDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MSDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required, The SDTMIG MSDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",8
Findings,MS,Central Processing,N/A,9,MSTIM,MS Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the (microbiology) specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of susceptibility test (as complete as possible).,MSDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MSDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis.,9
Findings,MS,Central Processing,N/A,10,MSCAT,MS Category for Organism Findings,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the microbiology susceptibility test?,[Microbiology Susceptibility Category]; NULL,Char,O,"Select the microbiology susceptibility category, or record if not pre-printed on the CRF.",MSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",10
Findings,MS,Central Processing,N/A,11,MSSCAT,MS Subcategory for Organism Findings,A sub-division of the MSCAT values based on user-defined characteristics.,What was the subcategory of the microbiology susceptibility finding?,[Microbiology Susceptibility Subcategory]; NULL,Char,O,"Select the microbiology susceptibility subcategory, or record if not pre-pre-printed on the CRF.",MSSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column header. MSSCAT can only be used if there is an MSCAT, and it must be a subcategorization of MSCAT.",11
Findings,MS,Central Processing,N/A,12,MSSPEC,MS Specimen Type,Defines the type of specimen used for a measurement.,What is the specimen material type?,Specimen Type,Char,R/C,Record the specimen material type.,MSSPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",12
Findings,MS,Central Processing,N/A,13,MSSPCCND,MS Specimen Condition,Description of the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,R/C,Record the condition of the specimen.,MSSPCCND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECCOND),N/A,May be collected using free or standardized text. This can be used when results may be affected by whether conditions for specimen were properly met.,13
Findings,MS,Central Processing,N/A,14,MSLOC,MS Specimen Collection Location,A description of the anatomical location of the subject relevant to the collection of specimen.,What was the anatomical location where the specimen was collected?,Anatomical Location,Char,O,Record or select the anatomical location of specimen collection.,MSLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",14
Findings,MS,Central Processing,N/A,15,MSLAT,MS Specimen Collection Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the specimen collection?,Side,Char,O,Record the side of the anatomical location of the specimen collection.,MSLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,15
Findings,MS,Central Processing,N/A,16,MSDIR,MS Specimen Collection Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the specimen collection?,Directionality,Char,O,Record the directionality of the anatomical location of the specimen collection.,MSDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,16
Findings,MS,Local Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",17
Findings,MS,Local Processing,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",18
Findings,MS,Local Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",19
Findings,MS,Local Processing,N/A,4,NHOID,Non-host Organism ID,"The identifier for a non-host organism, which should only be used when the organism is the subject of the test.",What was the non-host organism ID?,Non-host Organism ID,Char,O,Record the identifier for the non-host organism that is the subject of the test.,NHOID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined identifier for a non-host organism, which should only be used when the organism is the subject of the test",20
Findings,MS,Local Processing,N/A,5,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",21
Findings,MS,Local Processing,N/A,6,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable MIDTC in ISO 8601 format.",N/A,N/A,"The date the microbiology specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the microbiology susceptibility findings at that visit, or the specimen collection date can be included on the MS CRF using the date (MSDAT) field.",22
Findings,MS,Local Processing,N/A,7,MSPERF,MS Susceptibility Test Performed,"An indication of whether a planned measurement, series of measurements, tests or observations was performed.",Was the microbiology susceptibility test performed?,Microbiology Susceptibility Performed,Char,O,Indicate whether or not microbiology susceptibility test was performed.,MSSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable MSSTAT. If MSPERF = ""N"", the value of MSSTAT will be ""NOT DONE"". If MSPERF = ""Y"", MSSTAT should be null. A combination of SDTMIG variables (e.g., MSCAT and MSSCAT, MSTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable MSTESTCD would be populated as MSALL and an appropriate test name (MSTEST) provided. See SDTMIG for additional information.",(NY),N/A,This may be implemented for an entire panel. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.,23
Findings,MS,Local Processing,N/A,8,MSREFID,MS Reference ID,"An internal or external identifier, such as specimen identifier.",What was the (microbiology susceptibility test) [reference identifier/accession number]?,(Microbiology Susceptibility test) [Reference identifier/Accession Number],Char,O,Record the specimen [accession/reference] number assigned.,MSREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).",24
Findings,MS,Local Processing,N/A,9,MSSPID,MS Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",MSSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",25
Findings,MS,Local Processing,N/A,8,MSGRPID,MS Group ID,A group identifier used to link together a block of related records within a subject in a domain.,What [is/was] the [test/procedure/observation] group identifier?,[Test/Procedure/Observation] Group Identifier,Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each microbiology susceptibility test or result record has a unique identifier that will group records within a subject within the domain.",MSGRPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Used to link together a block of related records within a subject. Should not be used to link detection records in MB to the associated susceptibility results in the MS domain. NHOID should be used to identify the non-host organism.,26
Findings,MS,Local Processing,N/A,10,MSLNKID,MS Link ID,An identifier used to link related records across domains.,What [is/was] the [test/procedure/observation] link identifier?,[Domain/Observation] Link Identifier,Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each microbiology susceptibility result has an identifier that will link records across domains.",MSLNKID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This may be a one-to- one or a one-to-many relationship. For example, a single microbiology specimen or result may have multiple measurements/assessments performed (e.g., susceptibility testing).",27
Findings,MS,Local Processing,N/A,11,MSDAT,MS Specimen Collection Date,"The date of specimen collection ,represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the (microbiology) specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date of specimen collection using this format (DD-MON-YYYY).,MSDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MSDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. \n \n \n",28
Findings,MS,Local Processing,N/A,12,MSTIM,MS Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the the (microbiology) collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,MSDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MSDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis.,29
Findings,MS,Local Processing,N/A,13,MSCAT,MS Category for Organism Findings,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the microbiology susceptibility finding?,[Microbiology Susceptibility Category]; NULL,Char,O,"Select the microscopic finding category, or record if not pre-printed on the CRF.",MBCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a pre-printed category value on the CRF and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",30
Findings,MS,Local Processing,N/A,14,MSSCAT,MS Subcategory for Organism Findings,A sub-division of the MSCAT values based on user-defined characteristics.,What was the subcategory of the microbiology susceptibility finding?,[Microbiology Susceptibility Subcategory]; NULL,Char,O,"Select the microscopic finding subcategory, or record if not pre-printed on the CRF.",MSSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column header. MSSCAT can only be used if there is an MSCAT, and it must be a subcategorization of MSCAT.",31
Findings,MS,Local Processing,N/A,15,MSTEST,MS Organism Test or Finding Name,Descriptive name of the microbiology susceptibility test or examination used to obtain the measurement or finding.,What was the microbiology susceptibility test name?,[Microbiology Susceptibility Test Name],Char,HR,"Record the type or name of the microbiology susceptibility test or examination, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",MSTEST; MSTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable MSTESTCD may be determined from the value collected in MSTEST. Both MSTESTCD and MSTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(MSTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included as the column header.",32
Findings,MS,Local Processing,N/A,16,MSTSTDTL,Microbiology Susceptibility Test Detail,Detail of the microbiology susceptibility test used to obtain the measurement or finding. Helps to establish a unque record.,What was the microbiology susceptibility test detail?,Test Detail,Char,O,"Record the detail of the microbiology susceptibility test, if not pre-printed on the CRF.",MSTSTDTL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Provides additional details for the microbiology susceptibility test if necessary to define a unique record. It is recommended that the test detail be pre-printed on the CRF. If the form is laid out as a grid, then words such as ""Test Detail"" can be included as the column header.",33
Findings,MS,Local Processing,N/A,17,MSAGENT,Microbiology Susceptibility Agent,The name of the agent for which resistance is tested.,What was the name of the agent for which resistance is being tested?,Microbiology Susceptibility Agent,Char,O,Record the name of the agent for which resistance is being tested.,MSAGENT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,The name of the agent for which resistance is tested. The agent specified may be based on genetic markers or direct phenotypic drug sensitivity testing.,34
Findings,MS,Local Processing,N/A,18,MSCONC,MS Agent Concentration,The concentration of the agent for which resistance is tested.,What was the concentration of the agent?,Agent Concentration,Char,O,Record the concentration of the agent.,MSCONC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Numeric concentration of agent listed in MSAGENT,35
Findings,MS,Local Processing,N/A,19,MSCONCU,MS Agent Concentration Unit,The concentration unit of the agent for which resistance is tested.,What was the agent concentration unit?,Agent Concentration Unit,Char,O,Record the concentration unit of the agent.,MSCONCU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Units for value of the agent concentration listed in MSCONC,36
Findings,MS,Local Processing,N/A,20,MSORRES,MS Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the examination?,(Result),Char,HR,"Record test result, interpretation, or finding.",MSORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,37
Findings,MS,Local Processing,N/A,21,MSORRESU,MS Original Units,The unit of the result as originally received or collected.,What was the unit of the result?,Unit,Char,R/C,"Select the original unit in which these data were collected, or record if not pre-printed on the CRF.",MSORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere. For some tests, the units may not be applicable (e.g., where MSTEST requires simply a qualitative result).",38
Findings,MS,Local Processing,N/A,22,MSCLSIG,MS Clinical Significance,An indication whether the test results were clinically significant.,Was the result clinically significant?,Clinically Significant,Char,O,Indicate whether the results were clinically significant.,SUPPMS.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPMS dataset as the value of SUPPMS.QVAL where SUPPMS.QNAM="MSCLSIG" and SUPPMS.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,N/A,39
Findings,MS,Local Processing,N/A,23,MSRESCAT,MS Result Category,Used to categorize the result of a finding.,What was the result category?,Result Category,Char,O,Record the category of the test results.,MSRESCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Used to categorize the results of a finding (e.g., ""SUSCEPTIBLE"", ""RESISTANT"")",40
Findings,MS,Local Processing,N/A,24,MSNAM,MS Vendor Name,"The name or identifier of the vendor (e.g., laboratory) that provided the test results.",What was the name of the vendor used?,Vendor Name,Char,O,Record the laboratory name.,MSNAM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Recommended to collect on the CRF if lab name was not collected at the site/study level, or if multiple labs are used by a site",41
Findings,MS,Local Processing,N/A,25,MSSPEC,MS Specimen Type,Defines the type of specimen used for a measurement.,What is the specimen material type?,Specimen Type,Char,R/C,Record the specimen material type.,MSSPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",42
Findings,MS,Local Processing,N/A,26,MSSPCCND,MS Specimen Condition,Describes the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,O,Record the condition of the specimen.,MSSPCCND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECCOND),N/A,May be collected using free or standardized text. This can be used when results may be affected by whether conditions for specimen were properly met.,43
Findings,MS,Local Processing,N/A,27,MSLOC,MS Specimen Collection Location,"A description of the anatomical location of the subject, relevant to the collection of specimen.",What was the anatomical location where the specimen was collected?,Anatomical Location,Char,O,Record or select the anatomical location of specimen collection.,MSLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",44
Findings,MS,Local Processing,N/A,28,MSLAT,MS Specimen Collection Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the specimen collection?,Side,Char,O,Record the side of the anatomical location of the specimen collection.,MSLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,45
Findings,MS,Local Processing,N/A,29,MSDIR,MS Specimen Collection Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the specimen collection?,Directionality,Char,O,Record the directionality of the anatomical location of the specimen collection.,MSDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,46
Findings,MS,Local Processing,N/A,30,MSMETHOD,MS Method of Test or Examination,Method of the test or examination.,What was the method used for the test or examination?,Method,Char,O,Record the method of test or examination.,MSMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(METHOD),N/A,"This information may be collected when more than one method is possible, and collecting the method used is necessary. This could include technique or type of staining used for the slides.",47
Findings,MS,Local Processing,N/A,31,MSEVAL,MS Evaluator,The role of the person providing the evaluation.,Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",MSEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",48
Findings,MI,Central Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM- based dataset creation before submission.",1
Findings,MI,Central Processing,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,MI,Central Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,MI,Central Processing,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,MI,Central Processing,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation,or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable MIDTC in ISO 8601 format.",N/A,N/A,"The date the microscopic findings specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the microscopic findings at that visit, or the specimen collection date can be included on the MI CRF using the date (MIDAT) field.",5
Findings,MI,Central Processing,N/A,6,MIPERF,Microscopic Examination Performed,"An indication of whether a planned microbiology measurement, series of microbiology measurements, test, or observation was performed or specimens collected.",Was the microscopic examination performed?,Microscopic Examination Performed,Char,O,Indicate whether or not microscopic examination performed.,MISTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable MISTAT. If MIPERF=""N"", the value of MISTAT will be ""NOT DONE"". If MIPERF=""Y"", MISTAT should be null. A combination of SDTMIG variables (e.g., MICAT and MISCAT, MITPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable MITESTCD would be populated as MIALL and an appropriate test name (MITEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for an entire panel. This general prompt question is used as a data management tool to verify that missing results are confirmed missing. For the SDTM submission dataset, the SDTMIG variable MISTAT is populated using the CDASH field MIPERF. The question text used might be reflected in the reason not done (MIREASND).",6
Findings,MI,Central Processing,N/A,7,MIREFID,MI Reference ID,"An internal or external identifier, such as specimen identifier.",What was the (microscopic test) [reference identifier/accession number]?,(Microscopic test) [Reference Identifier/Accession Number],Char,O,Record the specimen [accession/reference] number assigned.,MIREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).",7
Findings,MI,Central Processing,N/A,8,MIDAT,Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date when specimen collection occurred using this format (DD-MON-YYYY).,MIDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MIDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required.",8
Findings,MI,Central Processing,N/A,9,MITIM,Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,MIDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MIDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on 1 day or when the timing in relationship to study treatment is required for analysis.,9
Findings,MI,Central Processing,N/A,10,MICAT,Category for Microscopic Finding,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the microscopic finding?,[Microscopic Category]; NULL,Char,O,"Record the microscopic finding category, if not pre-printed on the CRF.",MICAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",10
Findings,MI,Central Processing,N/A,11,MISCAT,Subcategory for Microscopic Finding,A sub-division of the MICAT values based on user-defined characteristics.,What was the subcategory of the microscopic finding?,[Microscopic Subcategory]; NULL,Char,O,"Record the microscopic finding subcategory, if not pre-printed on the CRF.",MISCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column header. MISCAT can only be used if there is an MICAT, and it must be a subcategorization of MICAT.",11
Findings,MI,Central Processing,N/A,12,MISPEC,MI Specimen Material Type,Defines the type of specimen used for a measurement.,What is the specimen material type?,Specimen Type,Char,R/C,Record the specimen material type.,MISPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",12
Findings,MI,Central Processing,N/A,13,MISPCCND,MI Specimen Condition,Describes the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,R/C,Record the condition of the specimen.,MISPCCND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECCOND),N/A,May be collected using free or standardized text. This can be used when results may be affected by whether conditions for specimen were properly met.,13
Findings,MI,Central Processing,N/A,14,MILOC,MI Specimen Collection Location,"A description of the anatomical location of the subject, relevant to the collection of specimen.",What was the anatomical location from which the specimen was collected?,Anatomical Location,Char,O,Record or select the anatomical location of specimen collection.,MILOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",14
Findings,MI,Central Processing,N/A,15,MILAT,MI Specimen Laterality within Subject,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the specimen collection?,Side,Char,O,Record the side of the anatomical location of the specimen collection.,MILAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,15
Findings,MI,Central Processing,N/A,16,MIDIR,MI Specimen Directionality within Subjct,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the specimen collection?,Directionality,Char,O,Record the directionality of the anatomical location of the specimen collection.,MIDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,16
Findings,MI,Local Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM- based dataset creation before submission.",17
Findings,MI,Local Processing,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",18
Findings,MI,Local Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",19
Findings,MI,Local Processing,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",20
Findings,MI,Local Processing,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable MIDTC in ISO 8601 format.",N/A,N/A,"The date the microscopic findings specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the microscopic findings at that visit, or the collection date can be included on the MI CRF using the date (MIDAT) field.",21
Findings,MI,Local Processing,N/A,6,MIPERF,Microscopic Examination Performed,"An indication of whether a planned microbiology measurement, series of microbiology measurements, test, or observation was performed or specimens collected.",Was the microscopic examination performed?,Microscopic Examination Performed,Char,O,Indicate whether or not microscopic examination was performed.,MISTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable MISTAT. If MIPERF=""N"", the value of MISTAT will be ""NOT DONE"". If MIPERF=""Y"", MISTAT should be null. A combination of SDTMIG variables (e.g., MICAT and MISCAT, MITPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable MITESTCD would be populated as MIALL and an appropriate test name (MITEST) provided. See SDTMIG for additional information.",(NY),N/A,This may be implemented for an entire panel. This general prompt question is used as a data management tool to verify that missing results are confirmed missing.,22
Findings,MI,Local Processing,N/A,7,MIREFID,MI Reference ID,"An internal or external identifier, such as specimen identifier.",What was the (microscopic test) [reference identifier/accession number]?,(Microscopic test) [Reference identifier/Accession Number],Char,O,Record the specimen [accession/reference] number assigned.,MIREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).",23
Findings,MI,Local Processing,N/A,8,MISPID,MI Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",MISPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record preprinted number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",24
Findings,MI,Local Processing,N/A,9,MIDAT,Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date of specimen collection using this format (DD-MON-YYYY).,MIDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MIDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",25
Findings,MI,Local Processing,N/A,10,MITIM,Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,MIDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable MIDTC in ISO 8601 format.",N/A,N/A,May be required when multiple assessments are done on one day or when the timing in relationship to study treatment is required for analysis.,26
Findings,MI,Local Processing,N/A,11,MICAT,Category for Microscopic Finding,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the microscopic finding?,[Microscopic Category]; NULL,Char,O,"Record the microscopic finding category, if not pre-printed on the CRF.",MICAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",27
Findings,MI,Local Processing,N/A,12,MISCAT,Subcategory for Microscopic Finding,A sub-division of the MICAT values based on user-defined characteristics.,What was the subcategory of the microscopic finding?,[Microscopic Subcategory]; NULL,Char,O,"Record the microscopic finding subcategory, if not pre-printed on the CRF.",MISCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a pre-printed category value on the CRF and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column header. MISCAT can only be used if there is an MICAT, and it must be a subcategorization of MICAT.",28
Findings,MI,Local Processing,N/A,13,MITEST,Microscopic Examination Name,Descriptive name of the microscopic test or examination used to obtain the measurement or finding.,What [is/was] the name (of the microscopic [measurement/test/examination])?,[Microscopic Measurement/Test/Examination Name],Char,HR,"Record the type or name of the microscopic examination, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",MITEST; MITESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable MITESTCD may be determined from the value collected in MITEST. Both MITESTCD and MITEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(MITS),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included as the column header.",29
Findings,MI,Local Processing,N/A,14,MITSTDTL,Microscopic Examination Detail,Detail of the microscopic examination used to obtain the measurement or finding.,What [is/was] the [microscopic measurement/test/examination] detail name?,[Examination Name Detail],Char,O,"Record the detail of the microscopic examination, if not pre-printed on the CRF.",MITSTDTL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(MIFTSDTL),N/A,"Provides additional details for the microscopic examination. It is recommended that the test detail be pre-printed on the CRF. If the form is laid out as a grid, then words such as ""Test Detail"" can be included as the column header.",30
Findings,MI,Local Processing,N/A,15,MIORRES,MI Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the examination?,(Result),Char,HR,"Record the test result, interpretation, or finding.",MIORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,31
Findings,MI,Local Processing,N/A,16,MIORRESU,MI Original Units,The unit of the result as originally received or collected.,What was the unit of the result?,Unit,Char,R/C,"Select the original unit in which these data were collected, or record if not pre-printed on CRF.",MIORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere. For some tests, the units may not be applicable (e.g., reaction score for HER2).",32
Findings,MI,Local Processing,N/A,17,MICLSIG,MI Clinical Significance,An indication of whether the test results were clinically significant.,Was the result clinically significant?,Clinically Significant,Char,O,Indicate whether the results were clinically significant.,SUPPMI.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPMI dataset as the value of SUPPMI.QVAL where SUPPMI.QNAM="MICLSIG" and SUPPMI.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,N/A,33
Findings,MI,Local Processing,N/A,18,MIRESCAT,MI Result Category,Used to categorize the result of a finding.,What was the result category?,Result Category,Char,O,Record the category of the test results.,MIRESCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Used to categorize the results of a finding (e.g., MALIGNANT or BENIGN, RESISTANCE VARIANT for genetic variation)",34
Findings,MI,Local Processing,N/A,19,MINAM,Laboratory/Vendor Name,"The name or identifier of the vendor (e.g., laboratory) that provided the test results.",What was the name of the vendor used?,Vendor Name,Char,O,Record the laboratory name.,MINAM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Recommended to collect on the CRF if lab name was not collected at the site/study level or if multiple labs are used by a site,35
Findings,MI,Local Processing,N/A,20,MISPEC,MI Specimen Material Type,Defines the type of specimen used for a measurement.,What is the specimen material type?,Specimen Type,Char,R/C,Record the specimen material type.,MISPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",36
Findings,MI,Local Processing,N/A,21,MISPCCND,MI Specimen Condition,Describes the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,R/C,Record the condition of the specimen.,MISPCCND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECCOND),N/A,May be collected using free or standardized text. This can be used when results may be affected by whether conditions for specimen were properly met.,37
Findings,MI,Local Processing,N/A,22,MILOC,MI Specimen Collection Location,"A description of the anatomical location of the subject, relevant to the collection of specimen.",What was the anatomical location from which the specimen was collected?,Anatomical Location,Char,O,Record or select the anatomical location of specimen collection.,MILOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",38
Findings,MI,Local Processing,N/A,23,MILAT,MI Specimen Laterality within Subject,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the specimen collection?,Side,Char,O,Record the side of the anatomical location of the specimen collection.,MILAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,39
Findings,MI,Local Processing,N/A,24,MIDIR,MI Specimen Directionality within Subjct,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the specimen collection?,Directionality,Char,O,Record the directionality of the anatomical location of the specimen collection.,MIDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,40
Findings,MI,Local Processing,N/A,25,MIMETHOD,MI Method of Test or Examination,Method of the test or examination.,What was the method used for the test or examination?,Method,Char,O,Record the method of test or examination.,MIMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary. This could include technique or type of staining used for the slides.",41
Findings,MI,Local Processing,N/A,26,MIEVAL,MI Evaluator,The role of the person providing the evaluation.,Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",MIEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",42
Findings,OE,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,OE,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. EDC: This should be prepopulated.",2
Findings,OE,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What is the subject identifier?,Subject,Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be provided to the site using a pre-populated list in the system. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTM.",3
Findings,OE,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,OE,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,"The date the OE measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the OE CRF using the Ophthalmic Examinations (OEDAT) field.",5
Findings,OE,N/A,N/A,6,FOCID,Focus of Study-specific Interest,"An identifier used for the identification of a focus of study-specific interest on or within a subject or specimen (as described in the protocol), for which a measurement, test, or examination was performed, such as a drug application site (e.g., ""Injection site 1"", ""Biopsy site 1"", ""Treated site 1""), or a more specific focus (e.g., ""OD"" (right eye), ""Upper left quadrant of the back""). The value in this variable should have inherent semantic meaning.",Which eye/eyes?,Eye/Eyes,Char,HR,Record which [eye was/eyes were] the focus of the finding or observation.,FOCID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(OEFOCUS),N/A,This variable is expected to be populated for ophthalmic studies. It is used as the key identifying variable to denote the focus (which eye or eyes) of the test finding or observation.,6
Findings,OE,N/A,N/A,7,OEPERF,Ophthalmic Examination Performed,"An indication of whether a planned measurement, test, observation or specimen was performed/collected.",Was an ophthalmic examination performed?,Ophthalmic Examination Performed,Char,O,N/A,OESTAT,"This field does not map directly to an SDTM variable. May be used to populate a value into the SDTM variable OESTAT. If the CDASH variable OEPERF=""N"", the value of the SDTM variable OESTAT is ""NOT DONE"". If OEPERF= ""Y"", OESTAT is null. A combination of SDTM variables (e.g., OECAT and OESCAT, OETPT ) is used to indicate that multiple tests were not done. In this situation, the SDTM variable OETESTCD would be populated with OEALL and an appropriate test name (OETEST) provided. See SDTMIG v3.3 Section 4.5.1.2.",(NY),N/A,"This field is used to capture a response regarding whether a planned measurement, test, or observation was performed. A negative response can be collected as ""N"" and mapped to the --STAT variable in SDTM as ""NOT DONE"".",7
Findings,OE,N/A,N/A,8,OEDAT,Ophthalmic Examination Date,"The date of the ophthalmic examination measurement, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the ophthalmic examination measurement?,Date,Char,R/C,Record date of measurements using this format (DD-MON-YYYY).,OEDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable OEDTC in ISO 8601 format.",N/A,N/A,"The date of measurement can be determined from a collected date of visit (VISDAT); in such cases, a separate measurement date field is not required.",8
Findings,OE,N/A,N/A,9,OETIM,Ophthalmic Examination Time,"The time of the measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time the ophthalmic examination measurement?,Time,Char,R/C,Record time of measurement (as complete as possible).,OEDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,Collect time if it is relevant for the analysis.,9
Findings,OE,N/A,N/A,10,OETEST,"Name of Measurement, Test or Examination",Descriptive name for the test being performed.,What was the name of the ophthalmic [measurement/test/examination]?,[Ophthalmic Examination] Test Name,Char,HR,N/A,OETEST,Maps directly to the SDTM variable listed in the SDTM Target column. The SDTM variable OETESTCD may be determined from the value collected in OETEST. The SDTMIG variables OETESTCD and OETEST are required in SDTM.,(OETEST),N/A,"The test name will usually be pre-printed on the CRF, and not solicited as a question. If the form is laid out as a grid, then ""Test"" or ""Test Name"" can be included as the column heading. OETEST is most useful as the PROMPT on the field in which the RESULT for that test is collected. See CDASHIG metadata tables for domain-specific TEST codelist names (e.g. EGTEST, FATEST).",10
Findings,OE,N/A,N/A,11,OETSTDTL,"Measurement, Test or Examination Detail",A further description of OETESTCD and OETEST.,What was the [measurement/test/examination] detail name?,[Measurement/Test/Examination] Detail (Name),Char,O,N/A,OETSTDTL,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"It is recommended that the test detail name be pre-printed on the CRF. If the form is laid out as a grid, then ""Test"" or ""Test Name"" can be included in the column heading.",11
Findings,OE,N/A,N/A,12,OECAT,Category,A grouping of topic-variable values based on user-defined characteristics.,What was the [type/category] of the ophthalmic examination?,[Ophthalmic Examination Category]; NULL,Char,O,N/A,OECAT,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. Examples are provided in the CDASHIG metadata tables and in the SDTMIG. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading. Note: CDISC Controlled terminology (IECAT) is used for the IE domain.",12
Findings,OE,N/A,N/A,13,OESCAT,Subcategory,A sub-division of the OECAT values based on user-defined characteristics.,What was the [subtype/subcategory] of the ophthalmic examination?,[Ophthalmic Examination Subcategory]; NULL,Char,O,N/A,OESCAT,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. OESCAT can only be used if there is a OECAT. Examples are provided in the CDASHIG metadata table and in the SDTMIG. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. OESCAT can only be used if there is a OECAT.",13
Findings,OE,N/A,N/A,14,OEORRES,Result of Finding in Original Unit,Result of the measurement or finding as originally received or collected.,What was the result of the ophthalmic examination test?,([Result/Amount] of) [value from OETEST]; NULL,Char,HR,N/A,OEORRES,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,14
Findings,OE,N/A,N/A,15,OEORRESU,Original Unit,The unit of the result as originally received or collected.,What was the unit (of the [measurement/test/examination])?,Unit,Char,R/C,N/A,OEORRESU,Maps directly to the SDTM variable listed in the SDTM Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere.",15
Findings,OE,N/A,N/A,16,OERES,Collected Result or Finding,The result of the measurement or finding as originally received or collected.,What [is/was] the [result/amount] (of the [measurement/test/examination])?; [Is/Was] the result [normal/abnormal/absent/present/ sponsored defined response]?,([Result/Amount] of) [value from OETEST],Char,O,N/A,OEORRES,"This does not map directly to an SDTM variable. The mapping instructions depend on the implementation, for example: Where OERES Normal, Abnormal or other similar type classifications (e.g., Absent/Present) with a description of the abnormal result using the CDASH field OEDESC. For SDTM submission datasets, If the CDASH field OERES = ""NORMAL"", populate the SDTM variables OEORRES and OESTRESC with the value of the CDASH field OERES. If the CDASH field OERES is ""ABNORMAL"", populate the SDTM variable OEORRES with the CDASH field OEDESC. If the reported findings in OEDESC are coded using a dictionary, then the SDTM variable OESTRESC is populated with the dictionary preferred term and OEMODIFY is populated with the modified text used for coding. If the reported findings in OEDESC are not coded, then the SDTM variable OESTRESC is populated with the CDASH OEDESC field. The SDTM variable OENRIND may be populated with ""NORMAL"" or ""ABNORMAL"" if appropriate. Where OERES is used to collect standardized values (e.g., a codelist) on the CRF and the value of ""OTHER"" is included, the CDASH field OERESOTH can be used to collect free-text values for ""Specify Other"". When using this field, the ""OTHER"" value recorded in the CDASH field OERES field is mapped to the SDTM variable OESTRESC and the value in the CDASH field OERESOTH is mapped to the SDTM variable OEORRES. See SDTMIG for additional information.",N/A,N/A,"The CDASH field OERES is used when the collected results are not mapped directly to the SDTM variable OEORRES and must be mapped, for example: OERES is used to collect standardized values on the CRF and the value of ""OTHER"" is included and ""Specify Other"" is collected. OERES is collected using Normal, Abnormal and a description of the abnormality is collected.",16
Findings,OE,N/A,N/A,17,OERESOTH,Result Other,A free-text result which provides further information about the original received or collected result.,"If other is selected, [explain/specify/provide more detail].",Specify ([Other/Details]),Char,O,N/A,OEORRES,"When using this CDASH field, the ""OTHER"" value collected in the CDASH field OERES is mapped to the SDTM variable OESTRESC and the value in the CDASH field OERESOTH is mapped to the SDTM variable OEORRES. See SDTMIG for additional information.",N/A,N/A,"In a case where OERES is used to collect standardized values on the CRF and the value of ""OTHER"" is included, the CDASH field OERESOTH can be used to collect free-text values for ""Specify Other"".",17
Findings,OE,N/A,N/A,18,OEORNRLO,Normal Range Lower Limit- Original Unit,The lower end of normal range or reference range for continuous results stored in OEORRES.,What was the lower limit of the reference range (for the [measurement/test/examination]?,Normal Range Lower Limit,Char,O,N/A,OEORNRLO,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,OEORNRLO should be populated only for continuous findings. The SDTM variable OESTNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.,18
Findings,OE,N/A,N/A,19,OEORNRHI,Normal Range Upper Limit- Original Unit,The upper end of normal range or reference range for continuous results stored in OEORRES.,What was the upper limit of the reference range (for the [measurement/test/examination])?,Normal Range Upper Limit,Char,O,N/A,OEORNRHI,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,OEORNRHI should be populated only for continuous findings. The SDTM variable OESTNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.,19
Findings,OE,N/A,N/A,20,OECSTNRC,Collected Character/Ordinal Normal Range,Normal references ranges that are expressed as characters ("Negative to Trace") or ordinal (-1 to 1).,What was the normal reference range (for this [measurement/test/examination])?,Normal Reference Range,Char,O,N/A,OESTNRC,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,Should be populated for normal ranges that are reported as character in ordinal scale or if categorical ranges were supplied. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.,20
Findings,OE,N/A,N/A,21,OENRIND,Normal/Reference Range Indicator,An indication or description about how the value compares to the normal range or reference range.,How do the reported values compare within the [reference/normal/expected] range?,Comparison to [Reference/Expected/Normal] Range,Char,O,N/A,OENRIND,Maps directly to the SDTM variable listed in the SDTM Target column.,(NRIND),N/A,"Reference ranges may be defined by OEORNRLO, OEORNRHI, OESTNRC, or other objective criteria. Reference Range Indicator (e.g., Y, N; HIGH, LOW; NORMAL, ABNORMAL) may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance.",21
Findings,OE,N/A,N/A,22,OERESCAT,Result Category,An indicator of the result of a finding or medical status per interpretation of test results.,What is the the category for the reported values?,Result Category,Char,O,N/A,OESTRESC,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Used to categorize the result of a finding or medical status per interpretation of test results (e.g., ""POSITIVE"", ""NEGATIVE""). The variable OERESCAT is not meant to replace the use of OENRIND for cases where normal ranges are provided.",22
Findings,OE,N/A,N/A,23,OEREASND,Reason Not Done,An explanation of why the data are not available.,What was the reason that the [ophthalmic examination finding] was not [collected/answered/done/assessed/evaluated]?,Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available],Char,O,N/A,OEREASND,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Sponsor-defined controlled terminology may be used. The reason data are not available may be chosen from a sponsor-defined codelist (e.g., broken equipment, subject refused) or entered as free text. When OEREASND is used, OESTAT should also be populated in the SDTM-based dataset.",23
Findings,OE,N/A,N/A,24,OELOC,Location,"The anatomical location of the subject, relevant to the collection of the measurement.",What was the anatomical location of the ophthalmic examination?,Anatomical Location,Char,O,N/A,OELOC,Maps directly to the SDTM variable listed in the SDTM Target column.,(LOC),N/A,"For the OE domain, this value is pre-populated as ""EYE"". It does not need to be pre-printed on the CRF or collected.",24
Findings,OE,N/A,N/A,25,OELAT,Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the [measurement/test/examination])?,Side,Char,O,N/A,OELAT,Maps directly to the SDTM variable listed in the SDTM Target column.,(LAT),N/A,Further detailing the laterality of the location of the OETEST within a given eye. It should never be used to designate "Right Eye" versus "Left Eye". OEFOCID is used to denote which eye is the focus of the observation. This may be pre-printed or collected.,25
Findings,OE,N/A,N/A,26,OEDIR,Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality (of the anatomical location of the [measurement/test/examination])?,Directionality,Char,O,N/A,OEDIR,Maps directly to the SDTM variable listed in the SDTM Target column.,(DIR),N/A,"Further detailing the directionality of the location of the OETEST (e.g., ANTERIOR, LOWER, PROXIMAL). This may be pre-printed or collected. Sponsors may collect the data using a subset list of CT on the CRF.",26
Findings,OE,N/A,N/A,27,OEPORTOT,Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of).",What was the portion or totality (of the anatomical location of the [measurement/test/examination])?,Portion or Totality,Char,O,N/A,OEPORTOT,Maps directly to the SDTM variable listed in the SDTM Target column.,(PORTOT),N/A,Further detailing the portion or totality of the location of the OETEST. This may be pre-printed or collected.,27
Findings,OE,N/A,N/A,28,OEMETHOD,Method of Test or Examination,The method of the test or examination.,What was the method (used for the [measurement/test/examination])?,Method,Char,R/C,N/A,OEMETHOD,Maps directly to the SDTM variable listed in the SDTM Target column.,(METHOD),N/A,N/A,28
Findings,OE,N/A,N/A,29,OEEVAL,Evaluator,The role of the person who provided the evaluation.,Who was the evaluator?,Evaluator,Char,O,N/A,OEEVAL,Maps directly to the SDTM variable listed in the SDTM Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed, or collected. Sponsors may collect the data using a subset list of CT on the CRF.",29
Findings,OE,N/A,N/A,30,OEEVALID,Evaluator Identifier,An identifier used to distinguish multiple evaluators with the same role recorded in OEEVAL.,What is the identifier of the evaluator?,Evaluator Identifier,Char,O,N/A,OEEVALID,Maps directly to the SDTM variable listed in the SDTM Target column.,(MEDEVAL),N/A,N/A,30
Findings,OE,N/A,N/A,31,OEACPTFL,Accepted Record Flag,"An indication that the evaluation is considered, by an independent assessor, to be the accepted or final evaluation.",Is this record considered to be the [accepted/final] evaluation?,[Accepted/Final] Evaluation,Char,O,N/A,OEACPTFL,Maps directly to the SDTM variable listed in the SDTM Target column.,(NY),N/A,"Used where more than 1 assessor provides an evaluation of a result or response. Typically a checkbox with the value of ""Y"" or ""NULL"", which indicates the evaluation was accepted.",31
Findings,OE,N/A,N/A,32,OEREPNUM,Repetition Number,"The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point, within a visit).",What was the repetition number within the time point for this measurement?,Repetition Number,Char,O,N/A,OEREFNUM,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"The repetition number of the test/measurement within the time point may be pre-printed on the CRF (e.g., multiple measurements of blood pressure, multiple analyses of a sample.",32
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable PCDTC in ISO 8601 format.",N/A,N/A,"The date the PK samples were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the PK samples at that visit, or the collection date can be collected on the PK CRF using the date (PCDAT) field.",5
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,6,PCPERF,PK Sampling Performed,An indication of whether PK samples were collected.,Were PK samples collected?,Collected,Char,O,Check "No" if none of the samples were collected.,PCSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable PCSTAT. If PCPERF=""N"", the value of PCSTAT will be ""NOT DONE"". If PCPERF=""Y"", PCSTAT should be null. PCTEST and PCTESTCD must reflect what tests were not done. A combination of SDTMIG variables ( e.g., PCCAT and PCSCAT, PCTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable PCTESTCD would be populated as PCALL and an appropriate test name (PCTEST) provided. See SDTMIG for additional information.",(NY),N/A,"General prompt question to be used as a data management tool to verify that missing results are confirmed missing. This may be implemented at form level or sample level. These may be all samples of a particular type or all samples taken for some purpose and may need to be identified by the organization of the data on the form. Each sample collected could result in 1 or more tests performed, so there can be a one-to-one or one-to-many relationship between samples and tests/results.",6
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,7,PCSTAT,PK Sampling Completion Status,"This variable used to indicate that data are not available, by having the site record the value as ""Not Done"".",Record "Not Done" if the PK sample was not collected.,Not Done,Char,HR,Indicate if the specimen was not done.,PCSTAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ND),N/A,"A Not Done checkbox, which indicates the test was ""NOT DONE"". Typically, there would be 1 checkbox for each measurement. This field can be useful on individual sample collections to confirm that a blank result field is meant to be blank.",7
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,8,PCREASND,PK Sampling Reason Not Done,An explanation for why the data are not available.,What was the reason the PK sample was not collected?,Reason Not Collected,Char,O,Provide the reason why a PK sample was not collected.,PCREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The reason the data are not available may be chosen from a sponsor-defined list (e.g., broken equipment, subject refused) or entered as free text. When PCREASND is used, the SDTMIG variable PCSTAT should also be populated in the SDTM-based dataset.",8
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,9,PCDAT,PK Sample Collection Date,"The date of PK sample collection or the start date of PK sample collection over a period of time (protocol-defined time-point range), represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the PK sample collection?,Collection Date,Char,HR,"Record the date when PK sample collection occurred using this format (DD-MON-YYYY). If left blank, ""PCDATFL"" for this specimen must be populated (or ""PCPERF"" must be flagged to indicate this sample was not collected).",PCDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable PCDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT); if so, a separate assessment date field is not required. The SDTMIG PCDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",9
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,10,PCDATFL,PK Sampling Date Flag,Flag indicating that the PK date (or start date) is the same as the previous specimen collection date (or start date).,Was the specimen/sample collected on the same date as the [last/previous specimen/sample] [collected/collection ended]?,Same as Previous (Specimen/Sample Collection End) Date,Char,O,"Select when the date of this specimen collection is the same as the date of the previous specimen collected. If left blank, ""PCDAT"" for this specimen must be populated. (or ""PCPERF"" must be flagged to indicate this sample was not collected)",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,N/A,N/A,"When a series of specimens are collected on a single form, this field is tied to the collection date to allow for the flag to be used as a surrogate for the date field. Its selection means that the date of this specimen is the same as the date of the last specimen collected (in the series). This variable may be used when collecting PK data and re-entering dates is more cumbersome than selecting the checkbox.",10
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,11,PCTIM,PK Sample Collection Time,"The time of PK sample collection or start time for a specimen collected over a period of time (protocol-defined time-point range), represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the PK sample collection?,Collection Time,Char,HR,Record time of collection (as complete as possible).,PCDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable PCDTC in ISO 8601 format.",N/A,N/A,"A complete time is expected. The SDTMIG PCDTC variable contains either a date/time, when a specimen is collected at a point in time, or the start date/time, when a specimen is collected over time.",11
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,12,PCTPT,PK Sampling Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol.",What was the planned time point of the PK sample collection?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for the PK sample collection, if not pre-printed on the CRF. Note: Planned time points are often described as relative to the dosing of the study drug.",PCTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. The SDTMIG time-point anchors PCTPTREF (text description) and PCRFTDTC (date/time) may be needed, as well as SDTMIG variables PCTPTNUM, PCELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as ""Planned Time Point"" can be included in the column heading.",12
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,13,PCFAST,PK Sampling Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,R/C,Record whether the subject was fasting prior to the test being performed.,PCFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"Results may be affected by whether the subject was fasting. Some study treatments may have a food effect, and it is important to know whether the dose was taken after the subject had fasted.",13
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,14,PCCOND,PK Sampling Test Condition Met,"Indication of whether the testing conditions defined in the protocol were met (e.g., low-fat diet).",Were the protocol-defined testing conditions met?,Test Condition Met,Char,R/C,Record whether protocol-defined testing conditions were met.,SUPPPC.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPPC dataset as the value of SUPPPC.QVAL where SUPPPC.QNAM ="PCCOND" and SUPP.PCLABEL= "Test Condition Met". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,"This information is collected when the test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF (e.g., ""Did subject meet diet requirements?""). This may not be relevant for all tests. Examples of conditions imposed may include calorie fast, fluid fast, high-fat meal, low-fat meal, and exercise.",14
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,15,PCREFID,PK Sampling Reference ID,"An internal or external identifier (e.g., specimen identifier).",What was the (PK) [reference identifier/accession number]?,(PK) [Reference Identifier/Accession Number],Char,O,Record the specimen or accession number assigned.,PCREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).",15
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,16,PCSPEC,PK Sampling Specimen Type,The type of specimen used for a PK sample.,What was the specimen (material) type?,[Specimen Type],Char,HR,"Record the specimen material type, if not pre-printed on the CRF.",PCSPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",16
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,17,PCTEST,PK Sampling Test Name,Descriptive name of the analyte or specimen characteristics used to obtain the PK measurement or finding.,What was the test name?,[Test Name],Char,O,"Record the name of the measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",PCTEST; PCTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable PCTESTCD may be determined from the value collected in PCTEST. The SDTMIG variables PCTESTCD and PCTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,N/A,N/A,"Sponsors typically collect tests related to the specimen characteristics on the CRF (e.g., Volume, Ph). Results for tests on an analyte (e.g., Concentration) would typically be populated when creating SDTM-based datasets. If the analyte test results are collected on the CRF, the test would be the analyte name. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",17
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,18,PCORRES,PK Sampling Result in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the test?,(Result),Char,O,"Record the test result, interpretation, or finding.",PCORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.",18
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,19,PCORRESU,PK Sampling Original Units,The unit of the result as originally received or collected.,What was the unit of the result?,Unit,Char,O,"Select the original unit in which these data were collected, or record if not pre-printed on CRF.",PCORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.",19
Findings,PC,PK Sample Collection over a Time Interval,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",20
Findings,PC,PK Sample Collection over a Time Interval,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",21
Findings,PC,PK Sample Collection over a Time Interval,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study,What is the subject identifier?,Subject,Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",22
Findings,PC,PK Sample Collection over a Time Interval,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",23
Findings,PC,PK Sample Collection over a Time Interval,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started),What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, or observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable PCDTC in ISO 8601 format.",N/A,N/A,"The date the PK samples were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the PK samples at that visit, or the collection date can be collected on the PK CRF using the date (PCDAT) field.",24
Findings,PC,PK Sample Collection over a Time Interval,N/A,6,PCPERF,PK Sampling Performed,An indication of whether PK samples were collected,Were PK samples collected?,Collected,Char,O,Indicate whether all of the PK samples in this group were collected.,PCSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable PCSTAT. If PCPERF=""N"", the value of PCSTAT will be ""NOT DONE"". If PCPERF=""Y"", PCSTAT should be null. PCTEST and PCTESTCD must reflect what tests were not done. A combination of SDTMIG variables (e.g., PCCAT and PCSCAT, PCTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable PCTESTCD would be populated as PCALL and an appropriate test name (PCTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This general prompt question is used as a data management tool to verify that missing results are confirmed missing. This may be implemented at form level or sample level. These may be all samples of a particular type, or all samples taken for some purpose, and may need to be identified by the organization of the data on the form. Each sample collected could result in 1 or more tests performed, so there can be a one-to-one or one-to-many relationship between samples and tests/results.",25
Findings,PC,PK Sample Collection over a Time Interval,N/A,7,PCREASND,PK Sampling Reason Not Done,An explanation for why the data are not available,What was the reason the PK sample was not collected?,Reason Not Collected,Char,O,Provide the reason why a PK sample was not collected.,PCREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The reason the data are not available may be chosen from a sponsor-defined list (e.g., broken equipment, subject refused) or entered as free text. When PCREASND is used, the SDTMIG variable PCSTAT should also be populated in the SDTM-based dataset.",26
Findings,PC,PK Sample Collection over a Time Interval,N/A,8,PCDAT,PK Sample Collection Date,"The date of PK sample collection or the start date of PK sample collection over a period of time (protocol-defined time-point range), represented in an unambiguous date format (e.g., DD-MON-YYYY)",What was the date of the PK sample collection?,Collection Date,Char,HR,"Record the date when PK sample collection occurred using this format (DD-MON-YYYY). If left blank, ""PCDATFL"" for this specimen must be populated (or ""PCPERF"" must be flagged to indicate this sample was not collected).",PCDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable PCDTC in ISO 8601 format..",N/A,N/A,"A complete date is expected. The SDTMIG PCDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",27
Findings,PC,PK Sample Collection over a Time Interval,N/A,9,PCTIM,PK Sample Collection Time,"The time of PK sample collection or start time for a specimen collected over a period of time (protocol-defined time-point range), represented in an unambiguous time format (e.g., hh:mm:ss)",What was the start time of the PK sample collection?,Collection Start Time,Char,HR,Record start time of collection (as complete as possible).,PCDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable PCDTC in ISO 8601 format..",N/A,N/A,"A complete time is expected. In interval collection, start can be added as needed to the question text, prompt and CRF directions. The SDTMIG PCDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",28
Findings,PC,PK Sample Collection over a Time Interval,N/A,10,PCENDAT,PK Sample Collection End Date,"The end date of the specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY)",What was the end date of the specimen collection?,(Collection) End Date,Char,HR,Record the date when PK sample collection stopped using this format (DD-MON-YYYY),PCENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable PCENDTC in ISO 8601 format.",N/A,N/A,"The end date of specimen collection may be determined from the date of visit and if so, a separate assessment date field is not required.",29
Findings,PC,PK Sample Collection over a Time Interval,N/A,11,PCENTIM,PK Sample Collection End Time,"The end time of the specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss)",What was the specimen collection end time?,(Collection) End Time,Char,HR,Record end time of collection (as complete as possible).,PCENDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH END DATE and TIME components and populate the SDTMIG variable PCENDTC in ISO 8601 format.",N/A,N/A,"A complete end time is expected. The SDTMIG variable PCENDTC variable contains the end date/time, when a specimen is collected over time. If there is no end date/time, the SDTMIG variable PCENDTC should be Null.",30
Findings,PC,PK Sample Collection over a Time Interval,N/A,12,PCTPT,PK Sampling Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol",What was the planned time point of the PK sample collection?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for the PK sample collection, if not pre-printed on the CRF. Note: Planned time points are often described as relative to the dosing of the study drug.",PCTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. The SDTMIG time-point anchors PCTPTREF (text description) and PCRFTDTC (date/time) may be needed, as well as SDTMIG variables PCTPTNUM, PCELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as ""Planned Time Point"" can be included in the column heading.",31
Findings,PC,PK Sample Collection over a Time Interval,N/A,13,PCFAST,PK Sampling Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time,Was the subject fasting?,Fasting,Char,R/C,Record whether the subject was fasting prior to the test being performed.,PCFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,"Results may be affected by whether the subject was fasting. Some study treatments may have a food effect, and it is important to know whether the dose was taken after the subject had fasted.",32
Findings,PC,PK Sample Collection over a Time Interval,N/A,14,PCCOND,PK Sampling Test Condition Met,"Indication of whether the testing conditions defined in the protocol were met (e.g., low fat diet)",Were the protocol-defined testing conditions met?,Test Condition Met,Char,R/C,Record whether protocol-defined testing conditions were met.,SUPPPC.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPPC dataset as the value of SUPPPC.QVAL where SUPPPC.QNAM ="PCCOND" and SUPP.PCLABEL= "Test Condition Met". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,"This information is collected when the test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF (e.g., ""Did subject meet diet requirements?""). Examples: calorie fast, fluid fast, high-fat meal, low-fat meal, exercise. This may not be relevant for all tests.",33
Findings,PC,PK Sample Collection over a Time Interval,N/A,15,PCREFID,PK Sampling Reference ID,"An internal or external identifier (e.g., specimen identifier)",What was the (PK) [reference identifier/accession number]?,(PK) [Reference Identifier/Accession Number],Char,O,Record the specimen or accession number assigned.,PCREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).",34
Findings,PC,PK Sample Collection over a Time Interval,N/A,16,PCSPEC,PK Sampling Specimen Type,The type of specimen used for a PK sample,What was the specimen (material) type?,Specimen Type,Char,HR,"Record the specimen material type, if not pre-printed on the CRF.",PCSPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",35
Findings,PC,PK Sample Collection over a Time Interval,N/A,17,PCTEST,PK Sampling Test Name,Descriptive name of the analyte or specimen characteristics used to obtain the PK measurement or finding,What was the test name?,[Test Name],Char,O,"Record the name of the measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",PCTEST; PCTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable PCTESTCD may be determined from the value collected in PCTEST. The SDTMIG variables PCTESTCD and PCTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,N/A,N/A,"Sponsors typically collect tests related to the specimen characteristics on the CRF (e.g., Volume, pH). Results for tests on an analyte (e.g., Concentration) would typically be populated when the SDTM-based datasets are created. If analyte test results are collected on the CRF, the test would be the analyte name. It is recommended that test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",36
Findings,PC,PK Sample Collection over a Time Interval,N/A,18,PCORRES,PK Sampling Result in Original Units,Result of the measurement or finding as originally received or collected,What was the result of the test?,(Result),Char,O,Record the PK sampling test result.,PCORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,37
Findings,PC,PK Sample Collection over a Time Interval,N/A,19,PCORRESU,PK Sampling Original Units,The unit of the result as originally received or collected,What was the unit of the result?,Unit,Char,O,Record the PK sampling test result.,PCORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,38
Findings,PE,PE-Traditional,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,PE,PE-Traditional,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,PE,PE-Traditional,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,PE,PE-Traditional,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,PE,PE-Traditional,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable PEDTC in ISO 8601 format.",N/A,N/A,"The date of the physical examination can be determined from the visit date variable (VISDAT) and applying that date to all of the physical examination findings at that visit, or the collection date can be included collected on the PE CRF using the date (PEDAT) field.",5
Findings,PE,PE-Traditional,N/A,6,PEPERF,Physical Examination Performed,An indication of whether a planned physical examination was performed.,Was the physical examination performed?,Physical Exam Performed,Char,O,"If the physical examination was performed as planned, select Yes; otherwise, select No.",PESTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable PESTAT. If PEPERF=""N"" the value of PESTAT=""NOT DONE"". If PEPERF=""Y"", then the actual physical exam results would be reported by body system (see PERES). PECAT, PESCAT, PETEST and PETESTCD must reflect what tests were not done. If used for an entire CRF or other set of multiple tests with PECAT and PESCAT, PETESTCD=PEALL.",(NY),N/A,"This general prompt question is used as a data management tool to verify that missing results are confirmed missing. Used to ask if the physical exam was performed at the overall subject level at the specified time point. If this field is used, the result should only be mapped to PESTAT if the overall examination (at the subject level) was not performed. If the overall examination was performed, then the value of PESTAT would be null for each examined body systems and ""NOT DONE"" for any body systems not examined (see PERES).",6
Findings,PE,PE-Traditional,N/A,7,PECAT,Category for Examination,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the physical examination?,[PE Category]; NULL,Char,O,"Select the physical examination category, or record if not pre-printed on the CRF.",PECAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. The CRF can capture different types of physical exams using PECAT (e.g., GENERAL, OPHTHAMOLOGIC, NEUROLOGICAL). This may be pre-printed on the CRF. If PECAT is not collected (e.g., it is evident from the protocol design), it could be populated when creating SDTM-based datasets.",7
Findings,PE,PE-Traditional,N/A,8,PESCAT,Subcategory for Examination,A sub-division of the PECAT values based on user-defined characteristics.,What was subcategory of the physical examination?,[PE Subcategory]; NULL,Char,O,"Select the physical examination subcategory, or record if not pre-printed on the CRF.",PESCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. The CRF can capture the different subtypes of PE categories using PESCAT. This may be pre-printed on the CRF. If PESCAT is not collected (e.g. it is evident from the protocol design), it could be populated when creating SDTM-based datasets. PESCAT can only be used if there is a PECAT, and it must be a subcategorization of PECAT.",8
Findings,PE,PE-Traditional,N/A,9,PEDAT,Physical Examination Date,"The date when the physical examination was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the physical examination?,Exam Date,Char,R/C,Record complete date of examination using this format (DD-MON-YYYY).,PEDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable PEDTC in ISO 8601 format.",N/A,N/A,"The date of examination may be determined from the date of the visit (VISDAT); if so, a separate assessment date field is not required.",9
Findings,PE,PE-Traditional,N/A,10,PETIM,Physical Examination Time,"The time of examination, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the physical examination?,Exam Time,Char,O,Record the time of examination (as complete as possible).,PEDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable PEDTC in ISO 8601 format.",N/A,N/A,Collect time if it is relevant for the analysis.,10
Findings,PE,PE-Traditional,N/A,11,PESPID,Physical Exam Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",PESPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",11
Findings,PE,PE-Traditional,N/A,12,PETEST,Body System Examined,Name of the body system.,What was the body system examined?,[Body System],Char,HR,"Per protocol, perform physical examinations of specified body systems.",PETEST; PETESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable PETESTCD may be determined from the value collected in PETEST.,N/A,N/A,"Sponsors should preprint all body systems to be examined on the CRF. The use of a complete list of body systems eliminates the need for an Other, Specify category; any abnormalities identified would fall under 1 of the specified categories. If the form is laid out as a grid, then words such as ""Body System"" can be included in the column heading.",12
Findings,PE,PE-Traditional,N/A,13,PERES,Physical Exam Verbatim Finding,Overall assessment of examined body system.,"Were the results normal, abnormal, or not done?",(Result),Char,HR,Indicate the overall assessment for each exam category/body system listed.,PEORRES,"This does not map directly to an SDTMIG variable. May be used to populate a value into the SDTMIG variable PEORRES. If PERES=""Normal"", populate PEORRES with the value of PERES. If PERES=""Abnormal"", populate PEORRES with the value of PEDESC.",N/A,N/A,"If the examined body system is normal, then the value in PEORRES should be ""NORMAL"". If the body system is not examined, then the value in PEORRES should be Null and the value in PESTAT should be ""NOT DONE"". If the examined body system is abnormal, then the value of PEORRES should contain the text of the abnormal findings (PEDESC). If the sponsor's data collection system allows for up-front recording of the abnormality and status using a single variable, then the SDTM variable name PEORRES may be used in place of CDASH variable names PERES and PEDESC. When creating SDTM-based datasets, PESTRESC is the standardized value for PEORRES and is populated for any record where PEORRES is not null. If the abnormal findings are coded using a dictionary, then PESTRESC should be the dictionary preferred term; if not coded, PEORRES.",13
Findings,PE,PE-Traditional,N/A,14,PEDESC,Physical Exam Abnormal Findings,Text description of any abnormal findings.,"If the result was abnormal, what were the findings?",Abnormal Findings,Char,HR,Record all abnormal findings for the given body system in the space provided.,PEORRES,"This does not map directly to an SDTMIG variable. May be used to populate a value into the SDTMIG variable PEORRES. If PERES=""Normal"", populate PEORRES with the value of PERES. If PERES=""Abnormal"", populate PEORRES with the value of PEDESC.",N/A,N/A,"If the examined body system is normal, then the value in PEORRES should be ""NORMAL"". If the body system is not examined, then the value in PEORRES should be Null and the value in PESTAT should be ""NOT DONE"". If the examined body system is abnormal, then the value of PEORRES should contain the text of the abnormal findings (PEDESC). If the sponsor's data collection system allows for up-front recording of the abnormality and status using a single variable, then the SDTM variable name PEORRES may be used in place of CDASH variable names PERES and PEDESC.",14
Findings,PE,PE-Traditional,N/A,15,PECLSIG,Physical Exam Clinical Significance,An indication of whether the physical examination abnormality is clinically significant.,Was the physical examination result clinically significant?,Clinically Significant,Char,O,Was the physical examination result clinically significant? Select Yes or No.,SUPPPE.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPPE dataset as the value of SUPPPE.QVAL where SUPPPE.QNAM ="PECLSIG" and SUPPPE.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,"If this level of information is needed for reconciliation with adverse events, this field may be added to the CRF.",15
Findings,PE,PE-Traditional,N/A,16,PEEVAL,Physical Exam Evaluator,The role of the person who provided the evaluation.,Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",PEEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",16
Findings,PE,PE-Traditional,N/A,17,PEREASND,Physical Exam Reason Not Examined,An explanation of why the data are not available.,What is the reason that data were not collected?,Reason Not Done,Char,O,Provide the reason the assessment was not done.,PEREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Captures the reason why the measurement or test was not done. The reason may be chosen from a sponsor-defined list (e.g., broken equipment, subject refused) or entered as free text.",17
Findings,PE,PE-Traditional,N/A,18,PEBODSYS,Body System or Organ Class,Body system or organ class that is involved for a finding from the standard hierarchy for dictionary-coded results.,What is/was the [body system/ organ system]?,[Body System/Organ System],Char,O,N/A,PEBODSYS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"PEBODSYS should be assigned using a coding system. If included on the CRF, it is prepopulated and must be paired by the sponsor with specific verbatim terms. If not included on the CRF, PEBODSYS is assigned through the coding process.",18
Findings,PE,PE-Traditional,N/A,19,PEMODIFY,Physical Exam Modified Reported Term,"If the value for PEORRES is modified for coding purposes, then the modified text is placed here.",N/A,N/A,Char,O,N/A,PEMODIFY,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This is not a data collection field that would appear on the CRF. Sponsors will populate this through the coding process. PEMODIFY contains any modified text used for coding. Used only when the reported abnormalities in PEORRES are coded to a dictionary. This is in contrast to Events and Interventions domains, where the topic variable (TERM or TRT) is modified for coding.",19
Findings,PE,PE-Traditional,N/A,20,PELOC,Location of Physical Exam Finding,"A description of the anatomical location of the subject, relevant to the collection of physical examination.",What was the anatomical location of the body system examined or the finding?,Anatomical Location,Char,O,Indicate the anatomical location of the abnormal finding.,PELOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",20
Findings,PE,PE-Traditional,N/A,21,PELAT,Physical Exam Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the body system examined or the finding?,Side,Char,O,Record the side of the anatomical location of the abnormal finding.,PELAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,21
Findings,PE,PE-Traditional,N/A,22,PEDIR,Physical Exam Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the of the body system examined or the finding?,Directionality,Char,O,Record the directionality of the anatomical location of the abnormal finding.,PEDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,22
Findings,PE,PE-Traditional,N/A,23,PEPORTOT,PE Location Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of).",What was the portion or totality of the anatomical location of the body system examined or the finding?,Portion or Totality,Char,O,Indicate the proportionality of the anatomical location of the of the abnormal finding.,PEPORTOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(PORTOT),N/A,Collected when the sponsor needs to identify the specific portionality for the anatomical locations. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,23
Findings,PE,PE-Traditional,N/A,24,PEMETHOD,PE Method of Test or Examination,Method of the test or examination.,What was the method used for the test or examination?,Method,Char,O,Record the method of test or examination.,PEMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary.",24
Findings,RP,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM- based dataset creation before submission.",1
Findings,RP,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,RP,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,RP,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,RP,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable RPDTC in ISO 8601 format.",N/A,N/A,"The date the reproductive system findings were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the reproductive system findings at that visit, or the collection date can be included on the RP CRF using the date (RPDAT) field.",5
Findings,RP,N/A,N/A,6,RPCAT,Category for Repro System Findings,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the reproductive system?,[Reproductive System Category]; NULL,Char,O,"Record the reproductive system category, if not pre-printed on the CRF.",RPCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",6
Findings,RP,N/A,N/A,7,RPSCAT,Subcategory for Repro System Findings,A sub-division of the RPCAT values based on user-defined characteristics.,What was the subcategory of the reproductive system?,Reproductive System Subcategory]; NULL,Char,O,"Record the reproductive system subcategory, if not pre-printed on the CRF.",RPSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. RPSCAT can only be used if there is an RPCAT, and it must be a subcategorization of RPCAT.",7
Findings,RP,N/A,N/A,8,RPPERF,Reproductive System Evaluation Performed,"An indication of whether a planned measurement, series of measurements, test, or observation was performed.",Was a reproductive system evaluation performed?,Reproductive System Evaluation Performed,Char,O,Indicate whether or not a planned reproductive system evaluation was done.,RPSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable RPSTAT. If the CDASH field RPPERF=""N"", the value of RPSTAT will be ""NOT DONE"". If RPPERF=""Y"", RPSTAT should be null. A combination of SDTMIG variables (e.g., RPCAT and RPSCAT, RPTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable RPTESTCD would be populated as RPALL and an appropriate test name (RPTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This may be implemented for a series of reproductive system evaluations, or a specific reproductive system test. This general prompt question is used as a data management tool to verify that missing results are confirmed missing.",8
Findings,RP,N/A,N/A,9,RPREASND,RP Reason Not Performed,An explanation for why the data are not available.,What was the reason the reproductive system test was not collected?,Reason Not Done,Char,O,Provide the reason the measurement or test was not done.,RPREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The reason the data are not available may be chosen from a sponsor-defined list (e.g., broken equipment, subject refused) or entered as free text. When PCREASND is used, the SDTMIG variable PCSTAT should also be populated in the SDTM-based dataset.",9
Findings,RP,N/A,N/A,10,RPYN,Any Reproductive System Findings,General prompt question regarding whether any reproductive system findings are available.,Were there any reproductive system findings?,Any Reproductive System Findings,Char,O,"Indicate if the there are reproductive system findings. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTMIG variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,10
Findings,RP,N/A,N/A,11,RPSPID,RP Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",RPSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",11
Findings,RP,N/A,N/A,12,RPTEST,Reproductive System Findings Test Name,Descriptive name for reproductive system finding.,What is the reproductive finding name?,[Reproductive System Findings Test Name],Char,HR,"Select the name of the reproductive system finding, or record if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",RPTEST; RPTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable RPTESTCD may be determined from the value collected in RPTEST. The SDTMIG variables RPTESTCD and RPTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(RPTEST),N/A,"Required to identify which test the result is for. It is recommended that test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",12
Findings,RP,N/A,N/A,13,RPORRES,RP Result or Finding in Original Units,"Result of the finding defined in reproductive system finding, as originally received or collected.",What was the result for the reproductive system question?,(Result),Char,HR,Record the reproductive system finding.,RPORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,13
Findings,RP,N/A,N/A,14,RPORRESU,RP Original Units,The unit of the result as originally received or collected.,What was the unit of the result?,Unit,Char,R/C,"Record the original unit in which these data were collected, if not pre-printed on the CRF.",RPORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.",14
Findings,RP,N/A,N/A,15,RPDAT,Reproductive System Finding Date,"The date on which the reproductive system result or finding was collected, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the reproductive system question was collected?,Collection Date,Char,R/C,Record the date of collection using this format (DD-MON-YYYY).,RPDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable RPDTC in ISO 8601 format.",N/A,N/A,This should be a complete date. The date of collection may be determined from the date of visit (VISDAT).,15
Findings,RE,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTM variable listed in the SDTM Target column .,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation.",1
Findings,RE,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,RE,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What is the subject identifier?,Subject,Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be provided to the site using a pre-populated list in the system. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,RE,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,RE,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,"The date the RE measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the RE CRF using the Respiratory Assessments (REDAT) field.",5
Findings,RE,N/A,N/A,6,REPERF,Respiratory Assessment Performed,"An indication of whether a planned measurement, test, observation or specimen was performed/collected.",Was a respiratory assessment performed?,Respiratory Assessment Performed,Char,HR,Indicate whether or not a respiratory assessment was done.,RESTAT,"This field does not map directly to an SDTM variable. May be used to populate a value into the SDTM variable RESTAT. If the CDASH variable REPERF="N", the value of the SDTM variable RESTAT is "NOT DONE". If REPERF= "Y", RESTAT is null. A combination of SDTM variables (e.g., RECAT and RESCAT, RETPT ) is used to indicate that multiple tests were not done. In this situation, the SDTM variable RETESTCD would be populated with REALL and an appropriate test name (RETEST) provided. See SDTMIG for additional information.",(NY),N/A,"This field is used to capture a response to whether or not a planned measurement, test or observation was performed. A negative response can be collected as "N" and mapped to the -STAT variable in SDTM as " NOT DONE".",6
Findings,RE,N/A,N/A,7,REDAT,Respiratory Assessment Date,"The date the respiratory measurement was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the respiratory measurement was taken?,Date,Char,R/C,Record date of measurements using this format (DD-MON-YYYY).,REDTC,"This field does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable REDTC in ISO 8601 format.",N/A,N/A,"The date the RE measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the RE CRF using the Date of Collection (REDAT) field.",7
Findings,RE,N/A,N/A,8,RETIM,Respiratory Assessment Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the respiratory system measurement?,Time,Char,R/C,Record time of measurement (as complete as possible).,REDTC,"This field does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable REDTC in ISO 8601 format.",N/A,N/A,"A single collection time (e.g., RETIM) may be collected for all the measurements when they are performed at the same time. The time of each measurement can also be collected using a CDASH variable [RETESTCD]_RETIM.",8
Findings,RE,N/A,N/A,9,RETPT,RE Assessment Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol.",What is the planned time point for this respiratory assessment measurement?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for respiratory assessment, if not pre-printed on the CRF.",RETPT,"Maps directly to the SDTM variable listed in the SDTM Target column. See the SDTMIG for additional information on representing time points. The SDTM time-point anchors RETPTREF (text description) and RERFTDTC (date/time) may be needed, as well as SDTMIG variables RETPTNUM, REELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as "Planned Time Point" can be included in the column heading.",9
Findings,RE,N/A,N/A,10,RETEST,Respiratory Test Name,Descriptive name of the test or examination used to obtain the measurement or finding.,What is the respiratory test name?,[Respiratory Test Name],Char,HR,"Record the name of the respiratory test, if not pre-printed on the CRF.",RETEST; RETESTCD,Maps directly to the SDTM variable listed in the SDTM Target column. The SDTM variable RETESTCD may be determined from the value collected in RETEST using the Controlled Terminology List RETESTCD. The SDTMIG variables RETESTCD and RETEST are required in SDTM.,(RETEST),N/A,"The test name will usually be pre-printed on the CRF, and not solicited as a question. If the form is laid out as a grid, then "Test" or "Test Name" can be included in the column heading. RETEST is most useful as the PROMPT on the field in which the RESULT for that test is collected.",10
Findings,RE,N/A,N/A,11,RECAT,Category for Respiratory Test,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the respiratory test?,[Respiratory Test Category]; NULL,Char,R/C,"Record the respiratory assessment category, if not pre-printed on the CRF.",RECAT,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. RESCAT can only be used if there is a RECAT. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included in the column heading.",11
Findings,RE,N/A,N/A,12,RESCAT,Subcategory for Respiratory Test,A sub-division of the RECAT values based on user-defined characteristics.,What was the subcategory of the respiratory assessment?,[Respiratory Assessment Subcategory]; NULL,Char,O,"Record the respiratory assessment subcategory, if not pre-printed on the CRF.",RESCAT,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included in the column heading. RESCAT can only be used if there is a RECAT, and it must be a subcategorization of RECAT.",12
Findings,RE,N/A,N/A,13,REORRES,RE Test Result in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the measurement?,[RETEST] Result,Char,HR,Record the respiratory test result.,REORRES,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,13
Findings,RE,N/A,N/A,14,REORRESU,Respiratory Test Original Unit,The unit of the result as originally received or collected.,What was the unit of the result?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",REORRESU,Maps directly to the SDTM variable listed in the SDTM Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere.",14
Findings,RE,N/A,N/A,15,RERES,Respiratory Test Result or Finding,The result of the measurement or finding as originally received or collected.,Was the result (normal/abnormal/absent/present/ [sponsored defined response])?,(Result),Char,O,Indicate the overall assessment for [RETEST].,REORRES,"This does not map directly to an SDTM variable. The mapping instructions depend on the implementation; for example: \n 1. Where RERES is to used collect Normal, Abnormal or similar type classifications (e.g., Absent/Present) with a description of the abnormal result using the CDASH field REDESC. For SDTM submission datasets, If the CDASH field RERES = "NORMAL", populate the SDTM variables REORRES and RESTRESC with the value of the CDASH field RERES. If the CDASH field RERES is "ABNORMAL", populate the SDTM variable REORRES with the CDASH field REDESC. If the reported findings in REDESC are coded using a dictionary, then the SDTM variable RESTRESC is populated with the dictionary preferred term and REMODIFY is populated with the modified text used for coding. If the reported findings in REDESC are not coded, then the SDTM variable RESTRESC is populated with the CDASH REDESC field. The SDTM variable RENRIND may be populated with "NORMAL" or "ABNORMAL" if appropriate. \n 2. Where RERES is used to collect standardized values (e.g. a codelist) on the CRF and the value of "OTHER" is included, the CDASH field RERESOTH can be used to collect free-text values for "Specify Other". When using this field, the "OTHER" value recorded in the CDASH field RERES field is mapped to the SDTM variable RESTRESC and the value in the CDASH field RERESOTH is mapped to the SDTM variable REORRES. See SDTMIG for additional information.",N/A,N/A,"The CDASH field RERES is used when the collected results are not mapped directly to the SDTM variable REORRES and must be transformed. For example,RERES is used to collect standardized values on the CRF and the value of "OTHER" is included and "Specify Other" is collected.REORES is collected using Normal, Abnormal and a description of the abnormality is collected.",15
Findings,RE,N/A,N/A,16,REDESC,Description of Respiratory Test Finding,Text description of respiratory test findings.,What was the description of the (abnormality/observed finding/[Sponsor-defined])?,(Abnormal) Findings,Char,O,Record all abnormal findings for the respiratory test in the space provided.,REORRES,"This does not map directly to an SDTM variable. May be used to populate a value into the SDTM variable REORRES. If RERES="Normal", populate REORRES with the value of RERES. If RERES="Abnormal", populate REORRES with the value of REDESC.",N/A,N/A,"RERES and REDESC are used when a question is asked to collect the finding result, with a follow-up question for a description of the finding. See CDASH General finding Assumptions",16
Findings,RE,N/A,N/A,17,RERESOTH,Respiratory Test Result Other,A free-text result which provides further information about the original received or collected result.,"If other is selected, [explain/specify/provide more detail].",[Specify Other/Explain/Specify Details],Char,O,Provide more detail for the "Other" result.,REORRES,"When using this CDASH field, the "OTHER" value collected in the CDASH field RERES is mapped to the SDTM variable RESTRESC and the value in the CDASH field RERESOTH is mapped to the SDTM variable REORRES.",N/A,N/A,"In cases where RERES is used to collect standardized values on the CRF and the value of "OTHER" is included, the CDASH field RERESOTH can be used to collect free-text values for "Specify Other".",17
Findings,RE,N/A,N/A,18,REORNRLO,RE Ref Range Lower Limit- Original Unit,The lower end of normal range or reference range for continuous results stored in REORRES.,What was the lower limit of the reference range?,Normal Range Lower Limit,Char,O,Record the lower limit of the reference range of the respiratory test.,REORNRLO,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,REORNRLO should be populated only for continuous findings. The SDTM variable RESTNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look-up table.,18
Findings,RE,N/A,N/A,19,REORNRHI,RE Ref Range Upper Limit- Original Unit,The upper end of normal range or reference range for continuous results stored in REORRES.,What was the upper limit of the reference range?,Normal Range Upper Limit,Char,O,Record the upper limit of the reference range of the respiratory test.,REORNRHI,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,REORNRHI should be populated only for continuous findings. The SDTM variable RESTNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look-up table.,19
Findings,RE,N/A,N/A,20,RENRIND,RE Reference Range Indicator,An indication or description about how the value compares to the normal range or reference range.,How do the reported values compare within the [reference/normal/expected] range?,Comparison to [Reference/Expected/Normal] Range,Char,O,Record where the test result fell with respect to the reference range.,RENRIND,Maps directly to the SDTM variable listed in the SDTM Target column.,(NRIND),N/A,"Reference ranges may be defined by REORNRLO, REORNRHI, RESTNRC or other objective criteria. Reference Range Indicator (e.g., Y, N; HIGH, LOW; NORMAL, ABNORMAL) may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance.",20
Findings,RE,N/A,N/A,21,RESTAT,Completion Status,"This variable is used to indicate that data are not available, by having the site recording the value as "Not Done".",Indicate if the [RETEST] was not [answered/assessed/done/evaluated/performed].,Not Done,Char,O,Indicate if the respiratory assessment or measurement was not done.,RESTAT,"Maps directly to the SDTM variable listed in the SDTM Target column. If collected, the Origin (a column in the Define-XML) ="CRF"; if populated from other sources such as free text or sponsor-defined listing for REREASND, the Origin ="DERIVED".",(ND),N/A,Used only when the response value is collected as NOT DONE or NULL in lieu of or in addition to the CDASH REPERF field. Typically a checkbox which indicates the test was NOT DONE. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank.,21
Findings,RE,N/A,N/A,22,REREASND,Reason Not Done,An explanation for why the data are not available.,Was the was the reason that the respiratory (assessment/[RETEST]) was not [collected / answered / done / assessed / evaluated]?,Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available],Char,O,Provide the reason the measurement or test was not done.,REREASND,Maps directly to the SDTM variable listed in the SDTM Target column.,N/A,N/A,"Sponsor-defined controlled terminology may be used. The reason the data are not available may be chosen from a sponsor-defined codelist (e.g., broken equipment, subject refused) or entered as free text. When REREASND is used, RESTAT should also be populated in the SDTM-based dataset.",22
Findings,RE,N/A,N/A,23,REPOS,Position of Subject During Observation,The position of the subject during a measurement or examination.,What was the position of the subject during the assessment?,Position,Char,O,Record the position of subject at time of test.,REPOS,Maps directly to the SDTM variable listed in the SDTM Target column.,(POSITION),N/A,"Results may be affected by whether conditions for respiratory test, as specified in the protocol, were properly met. One common condition is the subject's position. If the protocol requires this type of information, then a CDASH variable [RETESTCD]_REPOS may be created for each RETESTCD and added to the CRF, if needed.",23
Findings,RE,N/A,N/A,24,RELOC,Location,Location used for the measurement.,What was the anatomical location where the measurement was taken?,Anatomical Location,Char,O,Record or select location on body where the measurement was performed.,RELOC,Maps directly to the SDTM variable listed in the SDTM Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.LAT, DIR, and PORTOT are used to further describe the anatomical location.",24
Findings,RE,N/A,N/A,25,RELAT,Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the [measurement/test/examination])?,Side,Char,O,Record the side of the anatomical location of the respiratory test or measurement.,RELAT,Maps directly to the SDTM variable listed in the SDTM Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,25
Findings,RE,N/A,N/A,26,REDIR,Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the respiratory test?,Directionality,Char,O,Record the directionality of the anatomical location of the respiratory test.,REDIR,Maps directly to the SDTM variable listed in the SDTM Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,26
Findings,RE,N/A,N/A,27,REMETHOD,Method of Respiratory Test,The method of the test or examination.,What was the method (used for the [measurement/test/examination])?,Method,Char,O,Record the method used for the respiratory test.,REMETHOD,Maps directly to the SDTM variable listed in the SDTM Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary.",27
Findings,RE,N/A,N/A,28,REEVAL,Respiratory Test Evaluator,The role of the person who provided the evaluation.,Who was the evaluator?,Evaluator,Char,O,Select the role of the person who provided the evaluation.,REEVAL,Maps directly to the SDTM variable listed in the SDTM Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",28
Findings,RE,N/A,N/A,29,REEVALID,Respiratory Test Evaluator Identifier,An identifier used to distinguish multiple evaluators with the same role recorded in REEVAL.,What is the identifier of the evaluator?,Evaluator Identifier,Char,O,Record the unique identifier assigned to the person making the evaluation.,REEVALID,Maps directly to the SDTM variable listed in the SDTM Target column.,(MEDEVAL),N/A,Collect if multiple evaluators are used in the study (may be omitted if multiple evaluators are not used); values should follow controlled terminology.,29
Findings,RE,N/A,N/A,30,REACPTFL,Accepted Record Flag,"An indication that the evaluation is considered, by an independent assessor, to be the accepted or final evaluation.",Was this record considered to be the accepted evaluation?,Accepted Evaluation,Char,O,"Indicate whether or not the evaluation is considered, by an independent assessor, to be the accepted or final evaluation.",REACPTFL,Maps directly to the SDTM variable listed in the SDTM Target column.,(NY),N/A,"Use where more than one assessor provides an evaluation of a result or response. Typically a checkbox with the value of "Y" or "NULL", which indicates the evaluation was accepted.",30
Findings,RE,N/A,N/A,31,REREPNUM,Respiratory Test Repetition Number,"The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point, within a visit).",What was the repetition number within the time point for this measurement?,Repetition Number,Char,O,Record the repetition number of the measurement within the time point.,QVAL,This does not map directly to an SDTM variable. This information could be submitted in a SUPPRE dataset as the value of SUPPRE.QVAL where SUPPRE.QNAM = "REREPNUM" and SUPPRE.QLABEL= "Repetition Number within Time Point". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,N/A,N/A,The repetition number of the test/measurement within the time point may be pre-printed on the CRF.,31
Findings,RE,N/A,N/A,32,RECLSIG,Clinical Significance,An indication of whether the test results were clinically significant.,Was this result clinically significant?,Clinically Significant,Char,O,Record whether respiratory test results were clinically significant.,QVAL,This does not map directly to an SDTM variable. This information could be submitted in a SUPPRE dataset as the value of SUPPRE.QVAL when SUPPRE.QNAM = "CLSIG" and SUPPRE.QLABEL = "Clinical Significance". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,"Could apply to specific measurements or to overall interpretation, as required by the protocol.",32
Findings,RS,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,RS,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,RS,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,RS,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,RS,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. If the date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM), concatenate the CDASH VISDAT/VISTIM components and populate the SDTMIG variable RSDTC in ISO 8601 format.",N/A,N/A,"If the date the tests were collected can be determined from the visit date variable (VISDAT), apply that date to all of the tests at that visit, or the collection date can be collected on the CRF using the date (RSDAT). In this domain, it may not be appropriate to use the visit date as RSDTC.",5
Findings,RS,N/A,N/A,6,RSCAT,Category for Response or Clin Class,A grouping of topic-variable values based on user-defined characteristics.,What is the [category/ criteria] for the [disease response/clinical classification] or What is the [response/clinical classification] criteria?,[Disease Response/Clinical Classification Category]; NULL,Char,R/C,N/A,RSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(CCCAT);(ONCRSCAT),N/A,"This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response is typically a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading. There are separate codelists used for categorizing records about oncology response criteria (ONCRCAT) or other clinical classification (CRSCAT). Collect if multiple clinical classifications, or disease responses are active in a single study/database; otherwise, information should be distinguished somewhere on a form (e.g., table name, title, tab).",6
Findings,RS,N/A,N/A,7,RSSCAT,Subcategory for Response or Clin Class,A sub-division of the RSCAT values based on user-defined characteristics.,What is the subcategory for the [disease response/clinical classification]?,[Disease Response/Clinical Classification Sub-Category]; NULL,Char,R/C,N/A,RSSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. RSSCAT can only be used if there is an RSCAT, and it must be a subcategorization of RSCAT.",7
Findings,RS,N/A,N/A,8,RSPERF,Response or Clin Class Performed,An indication of whether a planned disease response or clinical classification assessment was performed.,Was the [(disease) response/clinical classification] assessment performed?,[Disease Response/Clinical Classification] Assessment,Char,O,Indicate whether or not the [disease response/clinical classification] assessment was performed.,RSSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTMIG variable RSSTAT. If RSPERF=""N"", the value of RSSTAT will be ""NOT DONE"". If RSPERF=""Y"", RSSTAT should be null. A combination of SDTMIG variables ( e.g., RSCAT and RSSCAT, RSTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable RSTESTCD would be populated as RSALL and an appropriate test name (RSTEST) provided. See SDTMIG for additional information.",(NY),N/A,"A Not Done checkbox, which indicates the test was ""NOT DONE"". Typically, there would be 1 check box for each measurement. This field can be useful to confirm that a blank result field is meant to be blank.",8
Findings,RS,N/A,N/A,9,RSREASND,Response or Clin Class Reason Not Done,An explanation of why the data are not available.,Why was the [disease response/clinical classification] assessment not performed?,Reason Response Assessment Not Performed,Char,O,"If the response was not collected, indicate why.",RSREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The reason that data are not available may be chosen from a sponsor-defined list (e.g., Not Imaged, Patient Refusal, Site Error) or entered as free text. When RSREASND is used, the SDTMIG variable RSSTAT should also be populated in the SDTM-based dataset.",9
Findings,RS,N/A,N/A,10,RSDAT,Response or Clin Class Assessment Date,"The date of the Response or Clin Class was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the response or clinical classification was performed?,Date,Char,R/C,Record the date of measurements using this format (DD-MON-YYYY).,REDTC,"This field does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable RSDTC in ISO 8601 format.",N/A,N/A,"The date the measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the RS CRF using the Date of Collection (RSDAT) field.",10
Findings,RS,N/A,N/A,11,RSEVAL,Response or Clin Class Evaluator,The role of the person who provided the information.,What was the role of the person performing the [disease response/clinical classification] assessment?,Evaluator,Char,R/C,Indicate who performed the assessment.,RSEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,Used only for results that are subjective (assigned by a person or a group). RSEVAL is expected for oncology response criteria. It can be null when the investigator provides all the data in a study. It should contain no null values when data from 1 or more evaluator are used in a study.,11
Findings,RS,N/A,N/A,12,RSEVALID,Response or Clin Class Evaluator ID,Used to distinguish multiple evaluators with the same role.,What is the evaluator identifier?,Evaluator Identifier,Char,O,Identify the evaluator providing this evaluation.,RSEVALID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(MEDEVAL),N/A,"When multiple assessors play the role identified in RSEVAL, values of RSEVALID will attribute a row of data to a particular assessor.",12
Findings,RS,N/A,N/A,13,RSLNKID,Response or Clin Class Link ID,An identifier used to link the disease response assessment to the related record in another domain which was used to determine the response result.,What was the [Disease Response or Clinical Classification ]Link ID Identifier?,[Disease Response or Clinical Classification ]Link ID,Char,O,"If collected, record the unique [Disease Response or Clinical Classification] Link ID.",RSLNKID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This variable is used to provide a unique code in order to link records across related CRFs (e.g., RS and TR) when appropriate. Sponsors develop their own conventions for populating RSLNKID.",13
Findings,RS,N/A,N/A,14,RSLNKGRP,Response or Clin Class Link Group,A grouping identifier used to link the disease response assessment to a group of related record in another domain which was used to determine the response result.,What was the [Disease Response or Clinical Classification] Link Group Identifier?,[Disease Response or Clinical Classification ]Link Group,Char,O,"If collected, record the unique [Disease Response or Clinical Classification] Link Group ID.",RSLNKGRP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This variable is used to provide a unique code in order to link a group of records across related CRFs (e.g., RS and TR) when appropriate. Sponsors develop their own conventions for populating RSLNKGRP.",14
Findings,RS,N/A,N/A,15,RSTEST,Response or Clin Class Assessment Name,Descriptive name of the disease response or clinical classification used to obtain the measurement or finding.,What was the [disease response/clinical classification] test name?,[Disease Response / Clinical Classification Test Name],Char,HR,"Record the name of the RS test, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",RSTEST; RSTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable RSTESTCD may be determined from the value collected in RSTEST. The SDTMIG variables RSTESTCD and RSTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(ONCRTS),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",15
Findings,RS,N/A,N/A,16,RSORRES,Response or Clin Class Original Result,"Result of the disease response or clinical classification as originally received, collected, or calculated.",What was the [disease response/clinical classification]?,(Result),Char,HR,Indicate the response classification.,RSORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,16
Findings,RS,N/A,N/A,17,RSORRESU,Response or Clin Class Original Units,The unit of the result as originally received or collected.,What was the [disease response/clinical classification] unit?,Unit,Char,HR,"Record or select the original units in which these data were collected, if not pre-printed on CRF.",RSORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere.",17
Findings,SC,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,SC,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,SC,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,SC,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,SC,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable SCDTC in ISO 8601 format.",N/A,N/A,"The date the subject characteristics were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the subject characteristics at that visit, or the collection date can be included on the SC CRF using the date (SCDAT) field.",5
Findings,SC,N/A,N/A,6,SCCAT,Category for Subject Characteristic,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the subject characteristics?,[Subject Characteristics Category ]; NULL,Char,O,"Record the subject characteristics category, if not pre-printed on the CRF.",SCCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",6
Findings,SC,N/A,N/A,7,SCSCAT,Subcategory for Subject Characteristic,A sub-division of the SCCAT values based on user-defined characteristics.,What was the subcategory of the subject characteristics?,[Subject Characteristics Subcategory]; NULL,Char,O,"Record the subject characteristics subcategory, if not pre-printed on the CRF.",SCSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. SCSCAT can only be used if there is an SCCAT, and it must be a subcategorization of SCCAT.",7
Findings,SC,N/A,N/A,8,SCPERF,SC Assessment Performed,An indication of whether any subject characteristics were collected.,Were subject characteristics collected?,Subject Characteristics Collected,Char,O,"Indicate if subject characteristics information was collected. If Yes, record the appropriate details.",SCSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable SCSTAT. If SCPERF=""N"", the value of SCSTAT will be ""NOT DONE"". If SCPERF=""Y"", SCSTAT should be null. A combination of SDTMIG variables (e.g., SCCAT and SCSCAT, SCTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable SCTESTCD would be populated as SCALL and an appropriate test name (SCTEST) provided. See SDTMIG for additional information.",(NY),N/A,General prompt question to be used as a data management tool to verify that missing results are confirmed missing.,8
Findings,SC,N/A,N/A,9,SCSPID,SC Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",SCSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",9
Findings,SC,N/A,N/A,10,SCDAT,Subject Characteristic Collection Date,"The date of collection represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the subject characteristics were collected?,Date,Char,R/C,Record the date the subject characteristics were collected using the format (DD-MON-YYYY).,SCDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable SCDTC in ISO 8601 format.",N/A,N/A,"The date of collection can be determined from a collected date of the visit (VISDAT); in such cases, a date field is not required.",10
Findings,SC,N/A,N/A,11,SCTEST,Subject Characteristic,Descriptive name of the subject characteristic of interest.,What is the subject characteristics name?,[Subject Characteristic Test Name],Char,HR,"Record the name of the subject characteristics if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",SCTEST;SCTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable SCTESTCD may be determined from the value collected in SCTEST. The SDTMIG variables SCTESTCD and SCTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(SCTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column header.",11
Findings,SC,N/A,N/A,12,SCORRES,SC Result or Finding in Original Units,Result of the subject characteristic as originally received or collected.,What is the subject characteristic?,(Result),Char,HR,Record the subject characteristic.,SCORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,N/A,12
Findings,SC,N/A,Horizontal-Generic,1,STUDYID,Study Identifier,A unique identifier for a study,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",13
Findings,SC,N/A,Horizontal-Generic,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",14
Findings,SC,N/A,Horizontal-Generic,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be provided to the site using a pre-populated list in the system. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTM.",15
Findings,SC,N/A,Horizontal-Generic,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is represented only in the SDTMIG DM domain. For more information, refer to SDTM Table 2.2.4.",16
Findings,SC,N/A,Horizontal-Generic,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable SCDTC in ISO 8601 format.",N/A,N/A,"The date the subject characteristics were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the subject characteristics at that visit, or the collection date can be included on the SC CRF using the date (SCDAT) field.",17
Findings,SC,N/A,Horizontal-Generic,6,[SCTESTCD]_SCCAT,Category for Subject Characteristic,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the subject characteristics??,[Subject Characteristics Category]; NULL,Char,O,"Record the subject characteristics category, if not pre-printed on the CRF.",SCCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading. This is an example of the types of CDASH variable names that can be used in a denormalized data structure.",18
Findings,SC,N/A,Horizontal-Generic,7,[SCTESTCD]_SCSCAT,Subcategory for Subject Characteristic,A sub-division of the SCCAT values based on user-defined characteristics.,What was the subcategory of the subject characteristics?,[Subject Characteristics Subcategory]; NULL,Char,O,"Record the subject characteristics subcategory, if not pre-printed on the CRF.",SCSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column header. SCSCAT can only be used if there is an SCCAT, and it must be a subcategorization of SCCAT. This is an example of the types of CDASH variable names that can be used in a denormalized data structure.",19
Findings,SC,N/A,Horizontal-Generic,8,[SCTESTCD]_SCPERF,SC Assessment Performed,An indication of whether any subject characteristics were collected.,Were subject characteristics collected for [SCTESTCD]?,[SCTEST] Collected,Char,O,"Indicate if subject characteristics information was collected. If Yes, include the appropriate details where indicated on the CRF.",SCSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable SCSTAT. If [SCTESTCD]_SCPERF =""N"", the value of SCSTAT will be ""NOT DONE"". If [SCTESTCD]_SCPERF =""Y"", SCSTAT should be null. A combination of SDTMIG variables (e.g., SCCAT and SCSCAT, SCTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable SCTESTCD would be assigned SCALL and an appropriate test name ( SCTEST) provided. See SDTMIG for additional information.",(NY),N/A,"General prompt question to be used as a data management tool to verify that missing results are confirmed missing. This may be implemented for all tests collected on the same horizontal record or for each specific test. When the SDTM-based datasets are created, the value of SCPERF would apply to all tests on the same record. Use the CDASH variable [SCTESTCD]_SCPERF when implemented on a specific test basis. This is an example of the types of CDASH variable names that can be used in a denormalized data structure.",20
Findings,SC,N/A,Horizontal-Generic,9,SCGRPID,Subject Characteristics Group ID,A sponsor-defined identifier used to tie together a block of related records in a single domain.,What is the test group identifier?,Test Group ID,Char,O,Record unique group identifier. Sponsors may insert additional instructions to ensure each record has a unique group identifier.,SCGRPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,It can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This group identifier ties together all the tests collected on this horizontal record. This field may be populated by the sponsor's data collection system.,21
Findings,SC,N/A,Horizontal-Generic,10,[SCTESTCD]_SCORRES,SC Result or Finding in Original Units,Result of the subject characteristics as originally received or collected.,What is the subject's [SCTEST]?,[SCTEST] Result,Char,HR,Record the subject characteristic.,SCORRES;SCTEST;SCTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,N/A,22
Findings,TU,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,TU,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,TU,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,TU,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,TU,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. If the date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM), then concatenate the CDASH VISDAT/VISTIM components and populate the SDTMIG variable TUDTC in ISO 8601 format.",N/A,N/A,"If the date the test was collected can be determined from the visit date variable (VISDAT), apply that date to all of the tests at that visit, or the collection date can be collected on the CRF using the date (TUDAT). In this domain, it may not be appropriate to use the visit date as TUDTC.",5
Findings,TU,N/A,N/A,6,TUCAT,Category of Tumor/Lesion Identification,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the [tumor/lesion] identification?,[Tumor/Lesion] Identification Category]; or NULL,Char,O,"Record the tumor identification category, if not pre-printed on the CRF.",TUCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",6
Findings,TU,N/A,N/A,7,TUSCAT,Subcategory Tumor/Lesion Identification,A sub-division of the TUCAT values based on user-defined characteristics.,What is the subcategory for the [tumor/lesion] identification?,[Tumor/Lesion] Identification Subcategory; or NULL,Char,O,"Record the tumor identification subcategory, if not pre-printed on the CRF.",N/A,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. TUSCAT can only be used if there is a TUCAT, and it must be a subcategorization of TUCAT.",7
Findings,TU,N/A,N/A,8,TUYN,Any Tumors/ Lesions Identification,An indication of whether any tumors were identified.,Were any [target/non-target/new/sponsor-defined) [tumors/lesions] identified?,Any ([Target/Non-target/New/Sponsor-defined) [Tumors/Lesions] Identified,Char,O,"Indicate whether [tumors/lesions] were identified. If Yes, include the appropriate details where indicated on the CRF.",N/A,Not submitted.,(NY),N/A,"This is intended to be used as a data management tool to verify that missing tumor/lesions evaluations are confirmed missing. The sponsor may decide to map ""No"" responses using the appropriate SDTMIG variables. Typically, this would use the SDTMIG variable TUOCCUR, with an appropriate TUTEST.",8
Findings,TU,N/A,N/A,9,TUDAT,Tumor/Lesion Identification Date,"The date of the [examination/procedure] used for tumor/lesion identification, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the [examination/procedure] used for [tumor/lesion identification]?,[Tumor/Lesion] Identification Procedure Date,Char,R/C,Record the scan/image/physical exam date used to identify the tumor/lesion using this format (DD-MON-YYYY).,TUDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable TUDTC in ISO 8601 format.",N/A,N/A,This is the date of the scan/image/physical exam used to identified the tumor/lesion. It is not the date the MRI or scan was read. This is typically not the visit date.,9
Findings,TU,N/A,N/A,10,TUEVAL,Tumor/Lesion Evaluator,The role of the person who provided the information.,Who provided the information?; Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",TUEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed, or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",10
Findings,TU,N/A,N/A,11,TUEVALID,Tumor/Lesion Evaluator Identifier,Used to distinguish multiple evaluators with the same role.,What was the identifier of the evaluator?,[Evaluator/Reporter] Identifier,Char,O,Record the unique identifier assigned to the person making the evaluation.,TUEVALID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(MEDEVAL),N/A,Collect if multiple evaluators are used in the study (may be omitted if multiple evaluators are not used); values should follow controlled terminology.,11
Findings,TU,N/A,N/A,12,TULNKID,Tumor/Lesion Identification Link ID,An identifier used to link identified tumor/lesion to the assessment result.,What was the [tumor/lesion] (link) identifier?,[Tumor/Lesion] ID,Char,HR,"If collected, record the unique identifier for this tumor/lesion.",TULNKID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This variable is used to provide a unique code for each identified tumor in order to link records across related CRFs (TU and TR) when appropriate. Sponsors develop their own conventions for populating --LNKID. Typically, the lesion/tumor is assigned the --LNKID at baseline when the tumor/lesion is identified, and the this --LNKID is used at other visits to collect assessments on this tumor/lesion.",12
Findings,TU,N/A,N/A,13,TUPRNO,Tumor/Lesion Related Procedure ID,The identifier for the procedure used to identify the tumor.,What was the identifier for the procedure used to identify this [tumor/lesion] ?,Procedure Identifier,Char,O,Record the procedure [ID or Line Number] used to evaluate the tumor/lesion.,N/A,"This does not map directly to an SDTMIG variable. For the SDTM submission datasets, may be used to create RELREC to link this record with a record in the PR domain.",N/A,N/A,Intent is to establish a link between the TU identified and the procedure undergone to identify this tumor/lesion. TUPRNO can be used to identify a relationship between records in the TU dataset and records in the PR dataset. See SDTMIG for information on RELREC.,13
Findings,TU,N/A,N/A,14,TUMETHOD,Tumor/Lesion Method of Identification,Method of the test or examination.,What was the method used to [evaluate/identify] the [tumor/lesion]?,Method of [Evaluation/Identification],Char,O,Record the method used to evaluate/identify the tumor/lesion.,TUMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(METHOD),N/A,"Sponsors may collect the method used to identify the tumor/lesions via a codelist which includes the most commonly known or generally recognized terms. The values will represent the method generically, not the product of the method (e.g., photograph). A sponsor may customize or restrict the list of values per response criteria or protocol needs. At a minimum, the primary method of identification should be entered and is expected to be consistent throughout the study; recording secondary methods is at the discretion of the sponsor.",14
Findings,TU,N/A,N/A,15,TUREFID,Tumor/Lesion Identification Reference ID,"An internal or external identifier, such as image ID number (e.g., CT scan, MRI, ultrasound identifier).",What was the procedure [reference identifier/accession number]?,[Tumor/Lesion] Reference ID,Char,O,Record the internal or external identifier assigned to the procedure/method used to identify the tumor/lesion.,TUREFID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,This variable may be used to collect a reference/accession number associated with the method used to identify the tumor/lesion. Sponsors may use the CDASH variable TUPRNO as an identifier for a procedure.,15
Findings,TU,N/A,N/A,16,TUTEST,Tumor/Lesion Identification Test Name,Descriptive name of the measurement or finding.,What was the [tumor/lesion] Identification test name?,[Tumor/Lesion Identification Test Name],Char,HR,"Record the name of the TU test, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",TUTEST; TUTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable TUTESTCD may be determined from the value collected in TUTEST. The SDTMIG variables TUTESTCD and TUTEST are required in SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(TUTEST),N/A,"Required to identify which test the result is for. It is recommended that test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",16
Findings,TU,N/A,N/A,17,TUORRES,Tumor/Lesion Identification Result,"Result of the tumor identification (e.g., classification or type of tumor).",What is the [type/classification] of [tumor/lesion] as defined by the criteria being employed?,(Result),Char,HR,"Record the TU classification. This may be pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",TUORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Each test may be collected using the CDASH variable [TESTCD], for example, TUMERGE, TUSPLIT, TUMIDENT or [TESTCD]_TUORRES where TESTCD is the appropriate CT for the TU test code. This is an example of the types of CDASH variable names that can be used in a denormalized data structure.",17
Findings,TU,N/A,N/A,18,TULOC,Location of the Tumor/Lesion,A description of the anatomical location of the identified tumor/lesion.,What was the anatomical location of the [tumor/lesion] (identified)?,Anatomical Location,Char,O,Record or select the anatomical location of the identified tumor/lesion.,TULOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location. A location detail text field (TULOCDTL) is conditional for entry (i.e., can be left blank) and allows the study site to specify the lesion in its own terms or can be used to distinguish tumors within the same location if other location qualifiers are not specific enough.",18
Findings,TU,N/A,N/A,19,TULAT,Tumor/Lesion Identification Laterality,"Qualifier for anatomical location, further detailing the side of the body relevant for the event.",What was the laterality of the anatomical location?,[Tumor/Lesion Identification] Side,Char,O,Record the side of the body within the anatomical location of the identified [tumor/lesion].,TULAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,19
Findings,TU,N/A,N/A,20,TUDIR,Tumor/Lesion Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location?,[Tumor/Lesion Identification] Directionality,Char,O,Record the directionality within the anatomical location of the identified [tumor/lesion].,TUDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,20
Findings,TU,N/A,N/A,21,TULOCDTL,TU Identification Location Detail,A detailed description of the location of the identified tumor/lesion.,What [were/are] additional details on the exact location of the [tumor/lesion] so that it can be distinguished from other [tumor/lesion] in the same anatomical location?,[Tumor/Lesion Identification] Location Detail,Char,O,Describe additional detail on the exact location of the tumor so that it can be distinguished from other tumors in the same anatomical location.,SUPPTU.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPTU dataset as the value of SUPPTU.QVAL where SUPPTU.QNAM="TULOCDTL" and SUPPTU.QLABEL= "TU Identification Location Detail".,N/A,N/A,"Use if TULOC and TULAT and/or TUDIR values cannot provide uniqueness from other identified tumors. TULOCDTL is not meant to replace TULOC, TULAT, and/or TUDIR or serve as the free-text description field for TULOC (e.g., Location, Other).",21
Findings,TU,N/A,N/A,22,TUNAM,Tumor/Lesion Identification Vendor Name,"The name or identifier of the vendor (e.g., laboratory) that provided the test results.",What was the name of the vendor used?,[Tumor/Lesion Identification] Vendor Name,Char,O,Record the name of the vendor providing the evaluation.,TUNAM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Recommended to collect on the CRF if vendor name was not collected at the site/study level or if multiple vendors are used by a site.,22
Findings,TR,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,TR,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,TR,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,TR,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,TR,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. If the date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable TRDTC in ISO 8601 format.",N/A,N/A,"If the date the test was collected can be determined from the visit date variable (VISDAT), apply that date to all of the tests at that visit, or the collection date can be collected on the CRF using the date (TRDAT). In this domain, it may not be appropriate to use the vist date as TRDTC.",5
Findings,TR,N/A,N/A,6,TRLNKGRP,Tumor/Lesion Result Link Group,An identifier used to link related records across domains.,What was the [tumor/lesion] [link group] identifier?,[Tumor/Lesion] [Link Group] ID,Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has the appropriate identifier.",TRLNKGRP,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Because TRLNKGRP is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. This is typically used in oncology clincial trials. It is intended to group all the assessments at a evaluation time point represented in the TR domain with the associated response assessments represented in the RS domain.",6
Findings,TR,N/A,N/A,7,TRCAT,Category of Tumor/Lesion Result,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the [tumor/lesion] results?,[Tumor/Lesion Result Category]; or NULL,Char,O,"Record the tumor/lesion result category, if not pre-printed on the CRF.",TRCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",7
Findings,TR,N/A,N/A,8,TRSCAT,Subcategory of Tumor/Lesion Result,A subgrouping of topic-variable values based on user-defined characteristics.,What is the subcategory of the [tumor/lesion] results?,[Tumor/Lesion Result Subcategory]; or NULL,Char,O,"Record the tumor/lesion result subcategory, if not pre-printed on the CRF.",TRSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and prepopulated in the data management system. This is not typically a question to which the site would provide an answer. TRSCAT can only be used if there is a TRCAT, and it must be a subcategorization of TRCAT.",8
Findings,TR,N/A,N/A,9,TRSTAT,Tumor/Lesion Result Completion Status,"This variable is used to indicate that data are not available, by having the site record the value as ""Not Done"".",Indicate if the [tumor/lesion] evaluation was not done.,Not Done,Char,O,Indicate if the [tumor/lesion] evaluation was not done.,TRSTAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ND),N/A,"A Not Done checkbox, which indicates the test was NOT DONE. Typically, there would be 1 check box for each result. This field can be useful to confirm that a blank result field is meant to be blank.",9
Findings,TR,N/A,N/A,10,TRREASND,Reason Tumor Measurement Not Performed,An explanation of why the data are not available.,What was the reason that the [tumor/lesion] was not [evaluated/assessed]?,Reason Not Done,Char,O,Provide the reason the result was not provided.,TRREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology may be used. The reason the data are not available may be chosen from a sponsor-defined codelist (e.g., broken equipment, subject refused) or entered as free text. When TRREASND is used, TRSTAT should also be populated in the SDTM-based dataset.",10
Findings,TR,N/A,N/A,11,TREVAL,Tumor/Lesion Result Evaluator,The role of the person who provided the information.,Who provided the information?; Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",TREVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",11
Findings,TR,N/A,N/A,12,TREVALID,Tumor/Lesion Result Evaluator Identifier,Used to distinguish multiple evaluators with the same role.,What was the identifier of the evaluator?,Evaluator Identifier,Char,O,Record the unique identifier assigned to the person making the evaluation.,TREVALID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(MEDEVAL),N/A,Collect if multiple evaluators are used in the study (may be omitted if multiple evaluators are not used); values should follow controlled terminology.,12
Findings,TR,N/A,N/A,13,TRDAT,Tumor/Lesion Result Date,"The date of the procedure used for tumor/lesion assessment, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the procedure used for [tumor/lesion] assessment?,[Tumor/Lesion] Assessment Procedure Date,Char,R/C,Record the date when the method used to assess the tumor/lesion occurred using this format (DD-MON-YYYY).,TRDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable TRDTC in ISO 8601 format.",N/A,N/A,This is the date of the scan/image/physical exam used to evaluate the tumor/lesion. It is not the date the MRI or scan was read. This is typically not the visit date.,13
Findings,TR,N/A,N/A,14,TRLNKID,Tumor/Lesion Result Link ID,An identifier used to link identified tumor/lesion to the assessment result.,What was the [tumor/lesion] Identifier?,[Tumor/ Lesion] ID,Char,R/C,"If collected, record the unique identifier for this tumor/lesion.",TRLNKID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"This variable is used to provide a unique code for each identified tumor in order to link records across related CRFs (TU and TR) when appropriate. Sponsors develop their own conventions for populating --LNKID. Typically, the lesion/tumor is assigned the --LNKID at baseline when the tumor/lesion is identified, and this --LNKID is used at other visits to collect assessments on this tumor or lesion. \n Note: This variable may be collected using 1 CDASH variable name (e.g., TULNKID) and populated into TRLNKID when creating submisson datasets.",14
Findings,TR,N/A,N/A,15,TRTEST,Tumor/Lesion Assessment Test Name,Descriptive name of the measurement or finding.,What was the [tumor/ lesion] (assessment) test name?,[Tumor/Lesion] (Assessment) Test Name],Char,HR,"Record the name of the tumor lesion assessment, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",TRTEST; TRTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable TRTESTCD may be determined from the value collected in TRTEST. The SDTMIG variables TRTESTCD and TRTEST are required in SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(TRTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",15
Findings,TR,N/A,N/A,16,TRORRES,TR Result or Finding in Original Units,Result of the tumor/lesion assessment.,What is the result for the [tumor/lesion assessment]?,(Result),Char,HR,Record the tumor/lesion assessment result.,TRORRES;TRTESTCD; TRTEST,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. In addition to the SDTMIG variable TRORRES, create TRTESTCD from the CDASH variable name and determine the value of TRTEST from TRTESTCD. The CDASH prompt may also contain the TRTEST. Use appropriate CDISC Controlled Terminology for the test and test code.",N/A,N/A,Result of the tumor/lesion assessment. Both quantitative and qualitative results may be recorded here.,16
Findings,TR,N/A,N/A,17,TRORRESU,TR Original Units,The unit of the result as originally received or collected.,What was the unit of the [result/measurement]?,Unit,Char,R/C,"Record or select the original units in which these data were collected, if not pre-printed on CRF.",TRORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Usually, the unit of the test is pre-printed on the CRF.",17
Findings,TR,N/A,N/A,18,TRNAM,Tumor/Lesion Result Vendor Name,"The name or identifier of the vendor (e.g., laboratory) that provided the test results.",What was the name of the vendor used?,Vendor Name,Char,O,Record the name of the vendor providing the evaluation.,TRNAM,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,It is recommended to collect on the CRF if vendor name was not collected at the site/study level or if multiple vendors are used by a site.,18
Findings,VS,N/A,Horizontal-Generic,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings,VS,N/A,Horizontal-Generic,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,VS,N/A,Horizontal-Generic,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings,VS,N/A,Horizontal-Generic,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,VS,N/A,Horizontal-Generic,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,"The date the VS measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the VS CRF using the date field (VSDAT).",5
Findings,VS,N/A,Horizontal-Generic,6,[VSTESTCD]_VSPERF,Vital Signs Performed,"An indication of whether a planned vital signs measurement, series of vital signs measurements, tests, or observations was performed.",Were [vital signs/[VSTEST] performed?,Vital Signs Performed ; [VSTEST] Performed,Char,O,"Indicate if the vital signs were collected. If Yes, include the appropriate details where indicated on the CRF.",VSSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable VSSTAT. If VSPERF=""N"", the value of VSSTAT will be ""NOT DONE"". If VSPERF=""Y"", VSSTAT should be null. A combination of SDTMIG variables (e.g., VSCAT and VSSCAT, VSTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable VSTESTCD would be populated as VSALL and an appropriate test name (VSTEST) provided. See SDTMIG for additional information.",(NY),N/A,"This general prompt question is used as a data management tool to verify that missing results are confirmed missing. This may be implemented for all tests collected on the same horizontal record or for each specific test. When mapped to SDTM, the value of VSPERF would apply to all tests on the same record. Use the CDASH variable [VSTESTCD]_VSPERF when implemented on a specific test basis.",6
Findings,VS,N/A,Horizontal-Generic,7,[VSTESTCD]_VSDAT,Vital Signs Date,"The date of the vital signs measurement, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the measurement(s)?,[VSTEST] Date,Char,R/C,Record date of measurements using this format (DD-MON-YYYY).,VSDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,"A single date may be collected for all the vital sign measurements when they are performed on the same date. The date of each measurement can also be collected for each measurement using a CDASH variable [VSTESTCD]_VSDAT. The date of the measurements may be determined from a collected date of visit; in such cases, a separate measurement date field is not required.",7
Findings,VS,N/A,Horizontal-Generic,8,[VSTESTCD]_VSTIM,Vital Signs Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the measurement(s)?,[VSTEST] Time,Char,R/C,Record time of measurement (as complete as possible).,VSDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,"A single collection time (e.g., VSTIM) may be collected for all the measurements when they are performed at the same time. The time of each measurement can also be collected using a CDASH variable [VSTESTCD]_VSTIM.",8
Findings,VS,N/A,Horizontal-Generic,9,VSCAT,Category for Vital Signs,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the vital signs?,[Vital Signs Category]; NULL,Char,O,"Record the vital signs category, if not pre-printed on the CRF.",VSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be from a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",9
Findings,VS,N/A,Horizontal-Generic,10,VSSCAT,Subcategory for Vital Signs,A sub-division of the VSCAT values based on user-defined characteristics.,What was the subcategory of the vital signs?,[Vital Signs Subcategory]; NULL,Char,O,"Record the vital signs subcategory, if not pre-printed on the CRF.",VSSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column header. VSSCAT can only be used if there is a VSCAT, and it must be a subcategorization of VSCAT.",10
Findings,VS,N/A,Horizontal-Generic,11,VSGRPID,Vital Signs Group ID,A sponsor-defined identifier used to tie a block of related records in a single domain.,What is the vital signs group identifier?,Test Group ID,Char,O,Record unique group identifier. The sponsor may insert additional instructions to ensure each record has a unique group identifier.,VSGRPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,It can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This group identifier ties together all the tests collected on the same horizontal record. This field may be populated by the sponsor's data collection system.,11
Findings,VS,N/A,Horizontal-Generic,12,[VSTESTCD]_VSTPT,Vital Signs Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol.",What is the planned time point for this vital signs measurement?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for vital signs, if not pre-printed on the CRF.",VSTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for information on representing time points. The SDTMIG time-point anchors VSTPTREF (text description) and VSRFTDTC (date/time) may be needed, as well as SDTMIG variables VSTPTNUM, VSELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading. The planned time point of each measurement can also be collected using the CDASH variable [VSTESTCD]_VSTPT.",12
Findings,VS,N/A,Horizontal-Generic,13,[VSTESTCD]_VSSTAT,Vital Signs Completion Status,"This variable is used to indicate that data are not available, by having the site recording the value as ""Not Done"".",Indicate if the [VSTEST] measurement was not done.,Not Done,Char,O,Indicate if the vital signs measurement was not done.,VSSTAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ND),N/A,"A single ""Not Done"" can be collected once for all tests on the same horizontal record using VSSTAT. The value of VSSTAT applies to all measurements on that record when mapped to SDTM. If needed, for each test ""NOT DONE"" may be collected using the CDASH variable [VSTESTCD]_VSSTAT.",13
Findings,VS,N/A,Horizontal-Generic,14,[VSTESTCD]_VSORRES,VS Result or Finding in Original Units,Result of the vital signs measurement as originally received or collected.,What was the result of the [VSTEST] measurement?,[VSTEST] (Result),Char,HR,Record the vital sign results.,VSORRES; VSTEST; VSTESTCD,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. In addition to the SDTMIG variable VSORRES, create VSTESTCD from the CDASH variable name and determine the value of VSTEST from VSTESTCD. The CDASH prompt may also contain the VSTEST. Use appropriate CDISC Controlled Terminology for the test and test code.",N/A,N/A,"Each test may be collected using the CDASH variable [TESTCD] e.g., SYSBP or [TESTCD]_VSORRES where TESTCD is the appropriate CT for the VS test code e.g., SYSBP_VSORRES. This is an examples of the types of CDASH variable names that can be used in a denormalized data structure.",14
Findings,VS,N/A,Horizontal-Generic,15,[VSTESTCD]_VSORRESU,VS Original Units,The unit of the result as originally received or collected.,What was the unit of the [VSTEST] measurement?,[VSTEST] Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",VSORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"A single Unit field can be collected once for all measurements collected on the same horizontal record using VSUNIT. The value of VSUNIT applies to all measurements on that record when mapped to SDTM. If needed for each measurement, unit may be collected using the CDASH variable [VSTESTCD]_VSORRESU. Should be pre-printed on the CRF (or enterable from a picklist) with the associated test when possible, rather than collected as free-text.",15
Findings,VS,N/A,Horizontal-Generic,16,[VSTESTCD]_VSCLSIG,Vital Signs Clinical Significance,An indication of whether the vital signs results were clinically significant.,Was the [VSTEST] result clinically significant?,[VSTEST] Clinically Significant,Char,O,Record whether the vital sign result was clinically significant.,SUPPVS.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM = "VSCLSIG" and SUPPVS.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables (NSVs) in SDTM domains.,(NY),N/A,"In horizontal data collection, a CDASH variable [VSTESTCD]_VSCLSIG may be created for each VSTESTCD and added to the CRF if needed.",16
Findings,VS,N/A,Horizontal-Generic,17,[VSTESTCD]_VSPOS,Vital Signs Position of Subject,The position of the subject during a measurement or examination.,What was the position of the subject during the [VSTEST] measurement?,[VSTEST] Position,Char,R/C,Record the position of subject at time of test (e.g. SITTING).,VSPOS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(POSITION),(VSPOS),"Results may be affected by whether conditions for vital signs as specified in the protocol were properly met. One common condition is the subject's position. If the protocol requires this type of information, then a CDASH variable [VSTESTCD]_VSPOS may be created for each VSTESTCD and added to the CRF, if needed.",17
Findings,VS,N/A,Horizontal-Generic,18,[VSTESTCD]_VSLOC,Location of Vital Signs Measurement,"A description of the anatomical location of the subject, relevant to the collection of vital signs measurements.",What was the anatomical location where the [VSTEST] measurement was taken?,[VSTEST] Anatomical Location,Char,O,"Record or select location on body where measurement was performed, if not pre-printed on CRF.",VSLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed on the CRF when the sponsor needs to identify the specific anatomical location (e.g., ARM for blood pressure). Sponsors may collect the data using a subset list of controlled terminology on the CRF. In horizontal data collection, a CDASH variable [VSTESTCD]_VSLOC may be created for each VSTESTCD and added to the CRF, if needed. LAT, DIR, and PORTOT are used to further describe the anatomical location.",18
Findings,VS,N/A,Horizontal-Generic,19,[VSTESTCD]_VSLAT,Vital Signs Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the [VSTEST] measurement?,Side,Char,O,Record the side of the anatomical location of the vital signs measurement.,VSLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,19
Findings,VS,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",20
Findings,VS,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",21
Findings,VS,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What is the subject identifier?,Subject,Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be provided to the site using a pre-populated list in the system. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTM.",22
Findings,VS,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",23
Findings,VS,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,"The date the VS measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the VS CRF using the Vital Signs Date (VSDAT) field.",24
Findings,VS,N/A,N/A,6,VSPERF,Vital Signs Performed,"An indication of whether a planned vital signs measurement, series of vital signs measurements, tests, or observations was performed.",Were vital signs performed?,Vital Signs Performed,Char,O,"Indicate if vital signs were collected. If Yes, include the appropriate details where indicated on the CRF.",VSSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable VSSTAT. If VSPERF=""N"", the value of VSSTAT will be ""NOT DONE"". If VSPERF=""Y"", VSSTAT should be null. A combination of SDTMIG variables (e.g., VSCAT and VSSCAT, VSTPT) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable VSTESTCD would be populated as VSALL and an appropriate test name VSTEST provided. See SDTMIG for additional information.",(NY),N/A,This general prompt question is used as a data management tool to verify that missing results are confirmed missing.,25
Findings,VS,N/A,N/A,7,VSDAT,Vital Signs Date,"The date of the vital signs measurement, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the vital signs measurement?,Date,Char,R/C,Record date of measurements using this format (DD-MON-YYYY).,VSDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,"The date of measurement can be determined from a collected date of visit (VISDAT); in such cases, a separate measurement date field is not required.",26
Findings,VS,N/A,N/A,8,VSTIM,Vital Signs Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the vital signs measurement?,Time,Char,R/C,Record time of measurement (as complete as possible).,VSDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,Collect time if it is relevant for the analysis.,27
Findings,VS,N/A,N/A,9,VSSPID,Vital Signs Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",VSSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",28
Findings,VS,N/A,N/A,10,VSTPT,Vital Signs Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol.",What is the planned time point for this vital signs measurement?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for vital signs, if not pre-printed on the CRF.",VSTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for information on representing time points. The SDTMIG time-point anchors VSTPTREF (text description) and VSRFTDTC (date/time) may be needed, as well as SDTMIG variables VSTPTNUM, VSELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",29
Findings,VS,N/A,N/A,11,VSCAT,Category for Vital Signs,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the vital signs?,[Vital Signs Category]; NULL,Char,O,"Record the vital signs category, if not pre-printed on the CRF.",VSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be from a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",30
Findings,VS,N/A,N/A,12,VSSCAT,Subcategory for Vital Signs,A sub-division of the VSCAT values based on user-defined characteristics.,What was the subcategory of the vital signs?,[Vital Signs Subcategory]; NULL,Char,O,"Record the vital signs subcategory, if not pre-printed on the CRF.",VSSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. VSSCAT can only be used if there is a VSCAT, and it must be a subcategorization of VSCAT.",31
Findings,VS,N/A,N/A,13,VSREPNUM,Vital Signs Repetition Number,"The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point, within a visit).",What was the repetition number within the time point for this measurement?,Repetition Number,Char,O,Record the repetition number of the measurement within the time point.,SUPPVS.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM= "VSREPNUM" and SUPPVS.QLABEL= "Repetition Number within time point". Refer to the current SDTM and SDTMIG for instructions on placement of NSVsdard variables in SDTM domains.,N/A,N/A,"The repetition number of the test/measurement within the time point may be pre-printed on the CRF (e.g., multiple measurements of blood pressure, multiple analyses of a sample).",32
Findings,VS,N/A,N/A,14,VSTEST,Vital Signs Test Name,Descriptive name of the test or examination used to obtain the measurement or finding.,What is the vital sign test name?,[Vital Signs Test Name],Char,HR,"Record the name of the vital sign test if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",VSTEST; VSTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTMIG variable VSTESTCD may be determined from the value collected in VSTEST. Both VSTESTCD and VSTEST are required in the SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(VSTEST),N/A,"Required to identify which test the result is for. It is recommended that test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",33
Findings,VS,N/A,N/A,15,VSSTAT,Vital Signs Completion Status,"This variable is used to indicate that data are not available, by having the site recording the value as ""Not Done"".",Indicate if the vital signs measurement was not done,Not Done,Char,O,Indicate if the vital sign measurement was not done.,VSSTAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(ND),N/A,"A Not Done checkbox, which indicates the test was NOT DONE. Typically, there would be 1 checkbox for each measurement. This field can be useful on individual VS tests to confirm that a blank result field is meant to be blank.",34
Findings,VS,N/A,N/A,16,VSORRES,VS Result or Finding in Original Units,Result of the vital signs measurement as originally received or collected.,What was the result of the measurement?,(Result),Char,HR,Record the vital sign result.,VSORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,N/A,35
Findings,VS,N/A,N/A,17,VSORRESU,VS Original Units,The unit of the result as originally received or collected.,What was the unit of the measurement?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",VSORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"This should be pre-printed on the CRF (or enterable from a picklist) with the associated test when possible, rather than collected as free-text.",36
Findings,VS,N/A,N/A,18,VSCLSIG,Vital Signs Clinical Significance,An indication whether the vital sign result was clinically significant.,Was the result clinically significant?,Clinically Significant,Char,O,Record whether the vital sign result was clinically significant.,SUPPVS.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM = "VSCLSIG" and SUPPVS.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of NSVs in SDTM domains.,(NY),N/A,N/A,37
Findings,VS,N/A,N/A,19,VSLOC,Location of Vital Signs Measurement,"A description of the anatomical location of the subject, relevant to the collection of vital signs measurements.",What was the anatomical location where the measurement was taken?,Anatomical Location,Char,O,"Record or select location on body where measurement was performed, if not pre-printed on CRF.",VSLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location (e.g., ARM for blood pressure). Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",38
Findings,VS,N/A,N/A,20,VSPOS,Vital Signs Position of Subject,The position of the subject during a measurement or examination.,What was the position of the subject during the measurement?,Position,Char,R/C,"Record the position of subject at time of test (e.g., SITTING).",VSPOS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(POSITION),(VSPOS),"Results may be affected by whether conditions for vital signs, as specified in the protocol, were properly met. One common condition is the subject's position.",39
Findings,VS,N/A,N/A,21,VSDIR,Vital Signs Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the measurement?,Directionality,Char,O,Record the directionality.,VSDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,40
Findings,VS,N/A,N/A,22,VSLAT,Vital Signs Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the vital signs measurement?,Side,Char,O,Record the side of the anatomical location of the vital signs measurement.,VSLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,41
Findings About Events or Interventions,FA,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings About Events or Interventions,FA,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings About Events or Interventions,FA,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings About Events or Interventions,FA,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings About Events or Interventions,FA,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable FADTC in ISO 8601 format.",N/A,N/A,"The date the finding about measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the FA CRF using the Findings About Date (FADAT) field.",5
Findings About Events or Interventions,FA,N/A,N/A,6,FAOBJ,Findings About Object of the Observation,A description of the object or focal point of the findings observation that is represented by FATEST.,[Sponsored-defined phrase],[Sponsored-defined phrase],Char,HR,[Protocol-specific],FAOBJ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The FAOBJ will usually be pre-printed or hidden, not solicited as an actual question. These FA domains are usually created by the sponsor.",6
Findings About Events or Interventions,FA,N/A,N/A,7,FAYN,Findings About Collected,An indication of whether data was collected for the finding topic.,Has the subject had any [Findings topic(s)] (after/before [study specific time frame])?; [Was/Were] (there) any [Findings topic(s)] (reported) (after/before [study specific time frame])?; Were all eligibility criteria met?,Any [Finding Topic],Char,O,"Indicate if the there are findings. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an SDTM variable. The SDTM annotated CRF indicates that this field is NOT SUBMITTED.,(NY),N/A,"This is a field that can be used in any CRF to indicate whether there is data to record. Used primarily as a data cleaning field, it provides verification that all other fields on the CRF were deliberately left blank. FAPERF should be used to capture a response about whether planned measurements, tests, or observations were done.",7
Findings About Events or Interventions,FA,N/A,N/A,8,FAPERF,Findings About Performed,"An indication of whether a planned measurement, series of measurements, test, observation or specimen was performed or collected.",[Were any/Was the] [FATEST/topic] ([measurement(s)/test(s)/examination(s)/specimen(s)/sample(s))] [performed/collected]?,([FATEST/ topic] ([Measurement (s)/Test(s)/Examination(s)/Specimen(s)/Sample(s)]) [Performed/Collected]?,Char,O,"Indicate if the [FATESTs] was/were collected. If Yes, include the appropriate details where indicated on the CRF.",FASTAT,"This field does not map directly to an SDTM variable. May be used to populate a value into the SDTM variable FASTAT. If the CDASH variable FAPERF=""N"", the value of the STDM variable FASTAT is ""OT DONE"". If FAPERF=""Y"", FASTAT is null. A combination of SDTM variables (e.g., FACAT and FASCAT, FATPT) is used to indicate that multiple tests were not done. In this situation, the SDTM variable FATESTCD would be populated with FAALL and an appropriate test name (FATEST) provided. See SDTMIG for additional information.",(NY),N/A,"This field is used to capture a response to whether a planned measurement, test or observation was performed. A negative response can be collected as ""N"" and mapped to the FASTAT variable in SDTM as ""NOT DONE"".",8
Findings About Events or Interventions,FA,N/A,N/A,9,FADAT,Findings About Assessment Date,"The date when the findings about assessment was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the findings about assessment was performed?,Date,Char,R/C,Record date of measurements using this format (DD-MON-YYYY).,FADTC,"This field does not map directly to an SDTM variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTM variable FADTC in ISO 8601 format.",N/A,N/A,"The date the FA measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the FA CRF using the Date of Collection (FADAT) field.",9
Findings About Events or Interventions,FA,N/A,N/A,10,FATIM,Findings About Assessment Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the findings about assessment?,Time,Char,R/C,Record time of measurement (as complete as possible).,FADTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable VSDTC in ISO 8601 format.",N/A,N/A,Collect time if it is relevant for the analysis.,10
Findings About Events or Interventions,FA,N/A,N/A,11,FATEST,Findings About Test Name,Descriptive name for the test being performed.,What [is/was] the name (of the [measurement/test/examination])?,[Measurement/Test/Examination/] (Name),Char,HR,"Record the name of the FATEST if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",FATEST;FATESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. The SDTM variable FATESTCD may be determined from the value collected in FATEST. The SDTMIG variables FATESTCD and FATEST are required in SDTM.,N/A,N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",11
Findings About Events or Interventions,FA,N/A,N/A,12,FATSTDTL,Findings About Test Detail,A further description of FATESTCD and FATEST.,What [is/was] the [measurement/test/examination] detail name?,[Measurement/Test/Examination] Detail (Name),Char,O,"Record the detail of the [FATEST], if not pre-printed on the CRF.",FATSTDTL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"It is recommended that the test detail name be pre-printed on the CRF. If the form is laid out as a grid, then words such as ""Test,"" ""Test Name"" can be included in the column heading.",12
Findings About Events or Interventions,FA,N/A,N/A,13,FACAT,Category for Findings About,A grouping of topic-variable values based on user-defined characteristics.,What [is/was] the [type/category/name] (of the [measurement/test/examination/specimen/sample])?,[Category/Category Value]; NULL,Char,O,"Record the FA category, if not pre-printed on the CRF.",FACAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",13
Findings About Events or Interventions,FA,N/A,N/A,14,FASCAT,Subcategory for Findings About,A sub-division of the FACAT values based on user-defined characteristics.,What [is/was] the [type/subcategory/name] (of the [measurement/test/examination/specimen/sample])?,[FA Subcategory/FA Subcategory Value]; NULL,Char,O,"Record the FA subcategory, if not pre-printed on the CRF.",FASCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. FASCAT can only be used if there is an FACAT, and it must be a subcategorization of FACAT.",14
Findings About Events or Interventions,FA,N/A,N/A,15,FAPOS,Findings About Position of Subject,The position of the subject during a measurement or examination.,In what position was the subject during the [measurement/ test/examination/specimen collection/sample collection]?; What was the position of the subject (during the [measurement/test/examination/specimen collection/sample collection])?,Position,Char,O,Record the position of the subject during the FA test.,FAPOS,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(POSITION),N/A,N/A,15
Findings About Events or Interventions,FA,N/A,N/A,16,FAORRES,FA Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What [is/was] the [result/amount/(subject's) characteristic] (of the [measurement/test/examination/question/assessment])?,([Result/Amount] of) [value from FATEST],Char,HR,Record the FATEST result.,FAORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,16
Findings About Events or Interventions,FA,N/A,N/A,17,FAORRESU,FA Original Units,The unit of the result as originally received or collected.,What [is/was] the unit (of the [measurement/test/examination])?,Unit,Char,R/C,"Select the unit of measure associated with the test, or record if not pre-printed on the CRF.",FAORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere.",17
Findings About Events or Interventions,FA,N/A,N/A,18,FAORNRLO,FA Normal Range Lower Limit- Orig Unit,The lower end of normal range or reference range for continuous results stored in FAORRES.,What [is/was] the lower limit of the reference range (for the [measurement/test/examination])?,Normal Range Lower Limit,Char,O,Record the lower limit of the reference range of the FA test.,FAORNRLO,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"--ORNRLO should be populated only for continuous findings. The SDTM variable --STNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment, or could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.",18
Findings About Events or Interventions,FA,N/A,N/A,19,FAORNRHI,FA Normal Range Upper Limit- Orig Unit,The upper end of normal range or reference range for continuous results stored in FAORRES.,What [is/was] the upper limit of the reference range (for the [measurement/test/examination])?,Normal Range Upper Limit,Char,O,Record the upper limit of the reference range of the FA test.,FAORNRHI,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"--ORNRHI should be populated only for continuous findings. The SDTM variable --STNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment, or could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.",19
Findings About Events or Interventions,FA,N/A,N/A,20,FANRIND,Findings About Reference Range Indicator,An indication or description about how the value compares to the normal range or reference range.,How [did/do] the reported values compare within the [reference/normal/expected] range?,Comparison to [Reference/Expected/Normal] Range,Char,O,"Record where the test results were categorized within the respective reference range (e.g. HIGH, LOW, ABNORMAL).",FANRIND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NRIND),N/A,"Reference ranges may be defined by FAORNRLO, FAORNRHI, FASTNRC or other objective criteria. Reference Range Indicator may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance.",20
Findings About Events or Interventions,FA,N/A,N/A,21,FASTAT,Findings About Completion Status,"This variable is used to indicate that data are not available, by having the site recording the value as ""Not Done"".",Was the [--TEST ] not [completed/answered/done/assessed/evaluated ]?; Indicate if the([--TEST] was) not [answered/assessed/done/evaluated/performed].,Not Done,Char,O,Indicate if the [FATEST] measurement was not done.,FASTAT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. If collected, the Origin (a column in the Define-XML) =""CRF"", if populated from other sources such as a free text or sponsor-defined listing for FAREASND, the Origin =""DERIVED"".",(ND),N/A,Used only when the response value is collected as NOT DONE or NULL in lieu of or in addition to the CDASH FAPERF field. Typically a checkbox which indicates the test was NOT DONE. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank.,21
Findings About Events or Interventions,FA,N/A,N/A,22,FAREASND,Findings About Reason Not Performed,An explanation of why data are not available.,Was the [is/was] the reason that the [Findings topic/data/information/sponsor-defined phrase] was not [collected/answered/done/assessed/evaluated]?,Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available],Char,O,Provide the reason why an FA test was not collected.,FAREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology may be used. The reason the data are not available may be chosen from a sponsor-defined codelist (e.g., broken equipment, subject refused, etc.) or entered as free text. When --REASND is used, --STAT should also be populated in the SDTM-based dataset.",22
Findings About Events or Interventions,FA,N/A,N/A,23,FASPEC,Findings About Specimen Type,The type of specimen used for a measurement.,What [is/was] the specimen type?,Specimen Type,Char,O,Record the specimen material type.,FASPEC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",23
Findings About Events or Interventions,FA,N/A,N/A,24,FASPCCND,Findings About Specimen Condition,Description of the condition of the specimen.,What [is/was] the condition of the specimen?,Specimen Condition,Char,O,Record the condition of the specimen.,FASPCCND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(SPECCOND),N/A,"May be collected using free or standardized text. Results may be affected by whether conditions for specimen were properly met. When local processing is used, sponsors may not routinely collect specimen condition.",24
Findings About Events or Interventions,FA,N/A,N/A,25,FALOC,Location of the Finding About,"The anatomical location of the subject, relevant to the collection of the measurement.",What [is/was] the anatomical location (of the [measurement/test/examination]) or What [is/was] the anatomical location where the [measurement/specimen] was taken/collected)?,Anatomical Location,Char,O,"Record or select location on body where the measurement was performed, if not pre-printed on CRF.",FALOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location (e.g., ARM for blood pressure). Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",25
Findings About Events or Interventions,FA,N/A,N/A,26,FALAT,Laterality of Location of Finding About,"Qualifier for anatomical location, further detailing the side of the body.",What [is/was] the side (of the anatomical location of the [measurement/test/examination])?,Side,Char,O,Record the side of the anatomical location of the [FATEST] measurement.,FALAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,26
Findings About Events or Interventions,FA,N/A,N/A,27,FADIR,Findings About Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What [is/was] the directionality (of the anatomical location of the [measurement/test/examination])?,Directionality,Char,O,Record the directionality.,FADIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,27
Findings About Events or Interventions,FA,N/A,N/A,28,FAPORTOT,FA Location Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e.,arrangement of, apportioning of).",What [is/was] the portion or totality (of the anatomical location of the [measurement/test/examination])?,Portion or Totality,Char,O,Indicate the portion or totality anatomical location.,FAPORTOT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(PORTOT),N/A,Collected when the sponsor needs to identify the specific portionality for the anatomical locations of the location of the FATEST. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,28
Findings About Events or Interventions,FA,N/A,N/A,29,FAMETHOD,Findings About Method,Method of the test or examination.,What was the method (used for the [measurement/test/examination])?,Method,Char,O,"Record the method used for the measurement, test, or examination.",FAMETHOD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(METHOD),N/A,N/A,29
Findings About Events or Interventions,FA,N/A,N/A,30,FALEAD,Findings About Lead,The lead or leads identified to capture the measurement for a test from an instrument.,What [is/was] the lead (used to measure [measurement/test/examination])?,Lead,Char,O,Record the lead used for measurement.,FALEAD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,N/A,30
Findings About Events or Interventions,FA,N/A,N/A,31,FAFAST,Findings About Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,[Is/Was] the subject fasting (prior to the [test being performed/sample being collected])?,Fasting,Char,O,Record whether the subject was fasting prior to the test being performed.,FAFAST,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,31
Findings About Events or Interventions,FA,N/A,N/A,32,FAEVAL,Findings About Evaluator,The role of the person providing the evaluation.,Who provided the (sponsor-defined phrase) information?; Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",FAEVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed, or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",32
Findings About Events or Interventions,FA,N/A,N/A,33,FAEVALID,Findings About Evaluator Identifier,An identifier used to distinguish multiple evaluators with the same role recorded in FAEVAL.,What [is/was] the identifier of the [evaluator name/reporter name] (providing the-sponsor-defined phrase-information)?,[Evaluator/Reporter] Identifier,Char,O,Record the unique identifier assigned to the person making the evaluation.,FAEVALID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(MEDEVAL),N/A,This variable is used in conjunction with FAEVAL to provide an additional level of detail.,33
Findings About Events or Interventions,FA,N/A,N/A,34,FACLSIG,Findings About Clinical Significance,An indication whether the test results were clinically significant.,[Is/Was] the ([measurement/test/examination]) result clinically significant?,([Measurement/Test/Examination/])/Clinically Significant,Char,O,Record whether the [FATEST] result was clinically significant.,SUPPFA.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPFA dataset as the value of SUPPFA.QVAL when SUPPFA.QNAM = "CLSIG" and SUPPFA.QLABEL = "Clinical Significance". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,N/A,34
Findings About Events or Interventions,SR,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during SDTM-based dataset creation before submission.",1
Findings About Events or Interventions,SR,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically pre-pinted in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-pinted on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings About Events or Interventions,SR,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This CDASH variable is typically collected in all CDASH domains. However, this CDASH variable is populated only in the SDTMIG DM domain. For more information, refer to the SDTMIG.",3
Findings About Events or Interventions,SR,N/A,N/A,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject.",What is the visit name?,[Visit],Char,R/C,N/A,VISIT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The name of the visit is typically pre-pinted on the CRF, and should match the name of the visit in the protocol. May be used to derive the SDTM variable VISITNUM. \n Note: Sponsors may have CDASH visit-numbering or visit-naming conventions to handle special circumstances (e.g., unscheduled visits). In such cases, the appropriate visit numbers and visit names may need to be populated when creating SDTM submission datasets.",4
Findings About Events or Interventions,SR,N/A,N/A,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an SDTM variable. The date of a measurement, test, or observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the CDASH VISDAT/VISTIM components and populating the SDTMIG variable SRDTC in ISO 8601 format.",N/A,N/A,"The date the skin response measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the skin response measurements at that visit, or the collection date can be included on the Skin Response CRF using the date (SRDAT) field.",5
Findings About Events or Interventions,SR,N/A,N/A,6,SRPERF,Skin Response Test Performed,"An indication of whether a planned skin response measurement, series of skin response measurements, tests, or observations was performed.",Was a skin response test performed?,Skin Response Test Performed,Char,O,Indicate if a skin response test was performed.,SRSTAT,"This does not map directly to an SDTMIG variable. May be used to derive a value into the SDTM variable SRSTAT. If SRPERF=""N"", the value of SRSTAT will be ""NOT DONE"". If SRPERF=""Y"", SRSTAT should be null. A combination of SDTMIG variables (e.g., SRCAT and SRSCAT, SRTPT ) is used to indicate that multiple tests were not done. In this situation, the SDTMIG variable SRTESTCD would be populated as SRALL and an appropriate test name (SRTEST) provided. See SDTMIG for additional information.",(NY),N/A,General prompt question to be used as a data management tool to verify that missing results are confirmed missing.,6
Findings About Events or Interventions,SR,N/A,N/A,7,SRREASND,Skin Response Reason Not Done,An explanation for why data are not available.,What was the reason the test was not done?,Reason Not Done,Char,O,Provide the reason why the test or examination was not done.,SRREASND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"The reason the data are not available may be chosen from a sponsor-defined list (e.g., broken equipment, subject refused) or entered as free text. When SRREASND is used, the SDTMIG variable SRSTAT should also be populated in the SDTM-based dataset.",7
Findings About Events or Interventions,SR,N/A,N/A,8,SRCAT,Skin Response Category for Test,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the skin response?,[Skin Response Category]; NULL,Char,O,"Record the skin response category, if not pre-pinted on the CRF.",SRCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",8
Findings About Events or Interventions,SR,N/A,N/A,9,SRSCAT,Skin Response Subcategory for Test,A sub-division of the SRCAT values based on user-defined characteristics.,What was the subcategory of the skin response?,[Skin Response Subcategory]; NULL,Char,O,"Record the skin response subcategory, if not pre-pinted on the CRF.",SRSCAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a sponsor-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. SRSCAT can only be used if there is an SRCAT, and it must be a subcategorization of SRCAT.",9
Findings About Events or Interventions,SR,N/A,N/A,10,SRSPID,Skin Response Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, this is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",[Sponsor-defined question],[Sponsor defined],Char,O,"If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.",SRSPID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",10
Findings About Events or Interventions,SR,N/A,N/A,11,SROBJ,Skin Response Object of the Observation,A description of the object or focal point of the findings observation that is represented by SRTEST.,What intervention was performed to elicit the skin response?,[Intervention] Performed,Char,HR,Record the name of the antigen administered to the skin to elicit the skin response.,SROBJ,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,N/A,11
Findings About Events or Interventions,SR,N/A,N/A,12,SRRFTDAT,SR Date of Reference Time Point,"The date of the reference time point, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the [intervention] performed to elicit the skin response?,[Intervention] Administration Date,Char,R/C,Record the date of the test material administration using this format (DD-MON-YYYY).,SRRFTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable SRRFTDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. If the date of administration is collected on a separate CRF (e.g., VISDAT), then it should not be collected on the SR CRF.",12
Findings About Events or Interventions,SR,N/A,N/A,13,SRRFTTIM,SR Time of Reference Time Point,"The time of the reference time point, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the [intervention] performed to elicit the skin response?,[Intervention] Administration Time,Char,R/C,Record the time of the test material administration using this format (hh:mm:ss).,SRRFTDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable SRRFTDTC in ISO 8601 format.",N/A,N/A,"Collect time if it is relevant for the analysis of the skin response (e.g., multiple [intervention] administrations.)",13
Findings About Events or Interventions,SR,N/A,N/A,14,SRLOC,SR Location Used for Measurement,"A description of the anatomical location of the subject, relevant to the collection of skin response test.",What was the anatomical location of the skin response measurement?,Anatomical Location,Char,O,"Record or select location on body where the measurement was performed, if not pre-pinted on CRF.",SRLOC,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LOC),N/A,"Collected or pre-printed when the sponsor needs to identify the specific anatomical location (e.g., ARM for skin response). Sponsors may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",14
Findings About Events or Interventions,SR,N/A,N/A,15,SRLAT,Skin Response Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the skin response measurement?,Side,Char,O,Record the side of the anatomical location where the test was performed.,SRLAT,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(LAT),N/A,May be pre-printed or collected when the sponsor needs to identify the specific side of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,15
Findings About Events or Interventions,SR,N/A,N/A,16,SRTEST,Skin Response Test or Examination Name,Descriptive name of the test or examination used to obtain the measurement or finding.,What was the skin response test name?,[Skin Response Test Name],Char,HR,"Record the name of the skin response test if not pre-pinted on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",SRTEST;SRTESTCD,Maps directly to the SDTMIG variable listed in the SDTMIG Target column. SRTESTCD may be determined from the value collected in SRTEST. The SDTMIG variables SRTESTCD and SRTEST are required in SDTM submission datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(SRTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-pinted on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",16
Findings About Events or Interventions,SR,N/A,N/A,17,SRTPT,Skin Response Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol.,What was the planned time point for skin response measurement?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for skin response, if not pre-pinted on the CRF.",SRTPT,"Maps directly to the SDTMIG variable listed in the SDTMIG Target column. See the SDTMIG for additional information on representing time points. Time-point anchors SRTPTREF (text description) and SRRFTDTC (date/time) may be needed, as well as SDTMIG variables SRTPTNUM, SRELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points be pre-pinted on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",17
Findings About Events or Interventions,SR,N/A,N/A,18,SRDAT,Skin Response Observation Date,"The date of the measurements, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the skin response measurement?,Date,Char,R/C,Record the date of measurements using this format (DD-MON-YYYY).,SRDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable SRDTC in ISO 8601 format.",N/A,N/A,"The date of measurement can be determined from a collected date of the visit (VISDAT); in such cases, a separate measurement date field is not required.",18
Findings About Events or Interventions,SR,N/A,N/A,19,SRTIM,Skin Response Observation Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the skin response measurement?,Time,Char,R/C,Record the time of measurement (as complete as possible).,SRDTC,"This does not map directly to an SDTMIG variable. For the SDTM submission dataset, concatenate all collected CDASH DATE and TIME components and populate the SDTMIG variable SRDTC in ISO 8601 format.",N/A,N/A,The time of measurement (if required) can be determined from a collected time of the visit (VISTIM); in such cases. a separate measurement date field is not required.,19
Findings About Events or Interventions,SR,N/A,N/A,20,SRDIR,Skin Response Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the skin response measurement?,Directionality,Char,O,Record the directionality of the anatomical location where the test was performed.,SRDIR,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(DIR),N/A,May be pre-printed or collected when the sponsor needs to identify the directionality of the anatomical location. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,20
Findings About Events or Interventions,SR,N/A,N/A,21,SREVAL,Skin Response Evaluator,The role of the person who provided the evaluation.,Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",SREVAL,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",21
Findings About Events or Interventions,SR,N/A,N/A,22,SREVALID,Skin Response Evaluator Identifier,Used to distinguish multiple evaluators with the same role recorded in SREVAL.,What was the identifier of the evaluator providing the skin response information?,[Evaluator/Reporter] Identifier,Char,O,Record the unique identifier assigned to the person making the evaluation.,SREVALID,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(MEDEVAL),N/A,If EVALID needs to be collected for each test on the horizontal record the CDASH variable [SRTESTCD]_ EVALID can be used.,22
Findings About Events or Interventions,SR,N/A,N/A,23,SRORRES,SR Results or Findings in Original Units,Result of the skin response test as originally received or collected.,What was the result of the skin response measurement?,(Result),Char,HR,Record the skin response test result.,SRORRES,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,N/A,N/A,N/A,23
Findings About Events or Interventions,SR,N/A,N/A,24,SRORRESU,SR Original Units,The unit of the result as originally received or collected.,What was the unit of the skin response measurement?,Unit,Char,R/C,"Record or select the unit of measurement associated with the test, if not pre-pinted on the CRF.",SRORRESU,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(UNIT),N/A,"Should be pre-pinted on the CRF with the associated test when possible, rather than collected in a free-text field.",24
Findings About Events or Interventions,SR,N/A,N/A,25,SRNRIND,Skin Response Reference Range Indicator,An indication or description about how the value compares to the normal range or reference range.,How [did/do] the reported values compare within the [reference/normal/expected] range?,Comparison to [Reference/Expected/Normal] Range,Char,O,"Record the categorization of the test results, within the respective reference range (e.g. HIGH, LOW, ABNORMAL).",SRNRIND,Maps directly to the SDTMIG variable listed in the SDTMIG Target column.,(NRIND),N/A,The category of the value within the respective reference range. Ranges may be defined by SRORNRLO and SRORNRHI or other objective criteria. Reference Range Indicator may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance.,25
Findings About Events or Interventions,SR,N/A,N/A,26,SRCLSIG,Skin Response Clinical Significance,An indication of whether the skin response result was clinically significant.,Was the result clinically significant?,Clinically Significant,Char,O,Record whether the skin response result was clinically significant.,SUPPSR.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPSR dataset as the value of SUPPSR.QVAL where SUPPSR.QNAM ="SRCLSIG" and SUPPSR.QLABEL="Clinically Significant". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,(NY),N/A,"If this level of information is needed, it may be added to the CRF.",26