CDASHIG 2.1 scraping for specifications

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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted for the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target. RDOMAIN contains the domain to which is related to the comment.,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,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
Special-Purpose,DM,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted for the CRFs that are shipped to each site. EDC: This should be prepopulated.",2
Special-Purpose,DM,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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",3
Special-Purpose,DM,N/A,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, etc.) 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 (complete date or whichever components are collected) 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 the AGE (SDTM expected variable), if not collected on the CRF, should be derived using a documented algorithm that describes how the age was determined and/or imputed for those birth dates collected with reduced precision.",4
Special-Purpose,DM,N/A,N/A,5,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 (complete date or whichever components are collected) 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 the 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,N/A,N/A,6,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 (complete date or whichever components are collected) 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 the 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,N/A,N/A,7,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 (complete date or whichever components are collected) 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 the 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.",7
Special-Purpose,DM,N/A,N/A,8,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 (complete date or whichever components are collected) 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 the 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.",8
Special-Purpose,DM,N/A,N/A,9,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 column with the heading SDTMIG Target.,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 an 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.",9
Special-Purpose,DM,N/A,N/A,10,AGEU,Age Units,Those 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 column with the heading SDTMIG Target.,(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 preprinted on the CRF (typically with the unit of ""years"").",10
Special-Purpose,DM,N/A,N/A,11,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.",11
Special-Purpose,DM,N/A,N/A,12,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 column with the heading SDTMIG Target.,(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.",12
Special-Purpose,DM,N/A,N/A,13,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 column with the heading SDTMIG Target.,(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/).,13
Special-Purpose,DM,N/A,N/A,14,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 v3.2 Section 5, 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).",14
Special-Purpose,DM,N/A,N/A,15,RACE,Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (U.S. 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 column with the heading SDTMIG Target.,(RACE),N/A,"Use RACE when the 5 designations for race used by the FDA are collected (American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander ; White).* Sponsors should refer to the FDA Guidance. See SDTMIG v3.2 Section 5, DM Domain. \n *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.",15
Special-Purpose,DM,N/A,N/A,16,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 v3.2 Section 5 for the DM Domain.,(RACEC),N/A,"Use CRACE when more detailed race categorizations are desired (e.g., more than the 5 minimum designations for race used by the FDA). The use of race and vocabulary tables located within the HL7 Reference Information Model Structural Vocabulary Tables is recommended, as they 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. \n *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.",16
Special-Purpose,DM,N/A,N/A,17,RACEOTH,Race Other,"A free-text field to be used when none of the preprinted values for RACE are applicable or if another, unprinted selection should be added to those preprinted 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 v3.2 Section 5, 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 of 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 categories specified by the FDA Guidance. See SDTMIG v3.2, Section 5 -DM Domain for examples of reporting this implementation.",17
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 column with the heading "SDTMIG Target".,N/A,N/A,"While 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 column with the heading "SDTMIG Target".,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading "SDTMIG Target".,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 SDTM Implementation Guide.",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 column with the heading "SDTMIG Target".,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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,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 column with the heading "SDTMIG Target".,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,CM,N/A,N/A,6,CMYN,Any Concomitant Medications Taken,An indication whether or not 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 is annotated to indicate 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 preprinted 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 column with the heading "SDTMIG Target". 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 preprinted 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 column with the heading "SDTMIG Target".,N/A,N/A,"In most cases, the verbatim drug names or treatment will be coded to a standard dictionary such as WHODrug after the data have been collected on the CRF. For the collection of verbatim drug name or treatments, 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 ATC selection. For example, 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 prespecified on a CRF.,N/A,N/A,Char,O,N/A,CMPRESP,Maps directly to the SDTMIG variable listed in the column with the heading "SDTMIG Target".,(NY),N/A,"For prespecified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both prespecified interventions as well as free-text interventions, the value of CMPRESP should be ""Y"" for all prespecified 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 is 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 column with the heading ""SDTMIG Target"". If the response 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 prespecific medication/treatment. CMOCCUR is not used for spontaneously free text reported concomitant medication/treatments. The site should be able to indicate that the response 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 is annotated to indicate 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 now codes to the ingredient level for many trade-named 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, contains Tenoxicam; in Estonia and Latvia, contains 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 column with the heading "SDTMIG Target".,N/A,N/A,"This is not the pharmacological/therapeutic classification of an agent (e.g., antibiotic, analgesic), but the reason for its administration to the subject. This additional information is collected on the CRF when sponsors want to capture the reason(s) why a subject took a medication/treatment. This information could be used as deemed appropriate for coding, analysis (e.g., in the classification of medications), for reconciling the 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 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,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 SDTMIG v3.2 Section 8.2 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 the SDTM submission datasets, may be used to create RELREC to link this record with a record in the Medical History domain.",N/A,N/A,Intent is to establish a link between the medical history condition and the medication/treatment taken for the medical history condition. CMMHNO can be used to identify a relationship between records in the CM dataset and records in the MH dataset. See SDTMIG v3.2 Section 8.2 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 column with the heading "SDTMIG Target".,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 dose 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 column with the heading "SDTMIG Target".,N/A,N/A,"For use when only total daily dose is collected in the CRF. For general medications/treatments, it is not recommended to use Total Daily Dose. Instead, this can be calculated from other fields such as Units, Dose, and 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 column with the heading "SDTMIG Target".,(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 column with the heading "SDTMIG Target".,(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 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 column with the heading "SDTMIG Target".,(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 utilizing 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 column with the heading "SDTMIG Target".,(ROUTE),(CMROUTE),This additional information may be important to collect on the CRF when the sponsor would want to capture a medication's/treatment's route of administration for purposes such as coding and the medication/treatment may have more than one 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 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. See Section 3.7, Mapping Relative Times from Collection to Submissions, and SDTMIG v3.2 Section 4.1.4.7 for more information.",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. When CMONGO is used in conjunction with another time point, the SDTM variables CMENRTPT and CMENTPT should be used. \n 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 SDTMIG v3.2 Section 4.1.4.7 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 such as CMENRF or CMENRTPT. When populating CMENRF, if the value of CMONGO is ""Y"", the value 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. \n 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 SDTMIG v3.2 Section 4.1.4 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 in 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 scenarios require it or the subject records the start 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,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 column with the heading "SDTMIG Target".,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 WHODrug, or a term in SNOMED, ICD9, or other published or sponsor-defined dictionaries.",28
Interventions,CM,N/A,N/A,29,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 column with the heading "SDTMIG Target".,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.,29
Interventions,CM,N/A,N/A,30,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 column with the heading "SDTMIG Target".,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.,30
Interventions,CM,N/A,N/A,31,CMATC1,ATC Level 1 Description,Dictionary text description of the first level of hierarchy within the Anatomical Therapeutic Chemical 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 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.,31
Interventions,CM,N/A,N/A,32,CMATC1CD,ATC Level 1 Code,Dictionary code denoting the first level of hierarchy within the Anatomical Therapeutic Chemical 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.,32
Interventions,CM,N/A,N/A,33,CMATC2,ATC Level 2 Description,Dictionary text description for the second level of hierarchy within the Anatomical Therapeutic Chemical 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 non-standard variables 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.,33
Interventions,CM,N/A,N/A,34,CMATC2CD,ATC Level 2 Code,Dictionary code denoting the second level of hierarchy within the Anatomical Therapeutic Chemical 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.,34
Interventions,CM,N/A,N/A,35,CMATC3,ATC Level 3 Description,Dictionary text description of the third level of hierarchy within the Anatomical Therapeutic Chemical 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 non-standard variables 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.,35
Interventions,CM,N/A,N/A,36,CMATC3CD,ATC Level 3 Code,Dictionary code denoting the third level of hierarchy within the Anatomical Therapeutic Chemical 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.,36
Interventions,CM,N/A,N/A,37,CMATC4,ATC Level 4 Description,Dictionary text description of the fourth level of hierarchy within the Anatomical Therapeutic Chemical 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 non-standard variables 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.,37
Interventions,CM,N/A,N/A,38,CMATC4CD,ATC Level 4 Code,Dictionary code denoting the fourth level of hierarchy within the Anatomical Therapeutic Chemical 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.,38
Interventions,CM,N/A,N/A,39,CMATC5,ATC Level 5 Description,Dictionary text description of the fifth level of hierarchy within the Anatomical Therapeutic Chemical 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 non-standard variables 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.,39
Interventions,CM,N/A,N/A,40,CMATC5CD,ATC Level 5 Code,Dictionary code denoting the fifth level of hierarchy within the Anatomical Therapeutic Chemical 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.,40
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,(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 preprinted 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 whether or not 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 aCRF is annotated to indicate 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 preprinted 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, since 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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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,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 column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 column with the heading SDTMIG Target.,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). In a masked study, if 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 prespecified on a CRF.,N/A,N/A,Char,O,N/A,ECPRESP,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(NY),N/A,"For prespecified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both prespecified interventions as well as free-text interventions, the value of ECPRESP should be ""Y"" for all prespecified 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 is 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 column with the heading SDTMIG Target. 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 of 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 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 column with the heading SDTMIG Target. 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 such as kit number, bottle label, or 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 column with the heading SDTMIG Target.,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. In this situation, 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target. Would only be populated when ECMOOD="PERFORMED".,(NY),N/A,Some study treatments may have a food effect and it is important to know whether the dose was taken while the subject was 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 column with the heading SDTMIG Target.,(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 on the same date, the collection of the end date is required. If the study design indicates that the start and end date 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 column with the heading SDTMIG Target.,(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., determined from protocol, randomization data). The unit should be preprinted 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 column with the heading SDTMIG Target.,(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 utilizing 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 column with the heading SDTMIG Target.,(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,The 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 column with the heading SDTMIG Target.,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 preprinted 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 whether or not 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 is annotated to indicate 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 associate 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 or explanation of why a dose of the study treatment is 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 column with the heading SDTMIG Target.,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 whether of not 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 SDTMIG Annotated CRF is annotated to indicate 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 non-standard variables 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,29,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 non-standard variables 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,30,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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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,31,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 column with the heading SDTMIG Target.,(LAT),N/A,Further details the laterality of the location where the study treatment was administered. This may be preprinted or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.,32
Interventions,EC,N/A,N/A,32,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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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,33,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 column with the heading SDTMIG Target. 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,34,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 column with the heading SDTMIG Target.,(UNIT),N/A,Unit of the administration amount.,35
Interventions,EC,N/A,N/A,35,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 non-standard variables in SDTM domains.,N/A,N/A,Infusion rate can be used to derive dose.,36
Interventions,EC,N/A,N/A,36,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 non-standard variables in SDTM domains.,(UNIT),(EXFLRTU),Unit of the infusion rate.,37
Interventions,EC,N/A,N/A,37,ECTPT,EC 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 [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 column with the heading SDTMIG Target. See 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 preprinted 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 header.",38
Interventions,EC,N/A,N/A,38,ECTRTCMP,Completed Treatment,An indication 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 non-standard variables 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"While 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,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,(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 preprinted on the CRF as the title of the page. See SDTMIG for further information regarding EPOCH.",4
Interventions,EX,N/A,N/A,5,EXYN,Any Study Treatment Taken,An indication whether or not 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 aCRF is annotated to indicate 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 preprinted on the CRF.",EXCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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 preprinted on the CRF.",EXSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 column with the heading SDTMIG Target.,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. Since 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 such as 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,(NY),N/A,Some study treatments may have a food effect and it is important to know whether the dose was taken while the subject was 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 column with the heading SDTMIG Target.,(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 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 scenarios 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 since 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 scenarios 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 column with the heading SDTMIG Target.,(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 preprinted 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 column with the heading SDTMIG Target.,(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 preprinted 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 utilizing 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,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 preprinted 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 whether or not 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 is annotated to indicate 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 or explanation of why a dose of the study treatment is 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 column with the heading SDTMIG Target.,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 whether of not 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 SDTMIG Annotated CRF is annotated to indicate 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 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 non-standard variables 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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target. 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 column with the heading SDTMIG Target.,(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 non-standard variables in SDTM domains.,N/A,N/A,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 non-standard variables 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 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 preprinted on the CRF.,EXTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. See 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 preprinted 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 header.",32
Interventions,EX,N/A,N/A,33,EXTRTCMP,Completed Treatment,Subject did not did not complete 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 non-standard variables 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 column with the heading SDTMIG Target.,(LAT),N/A,Further details the laterality of the location where the study treatment was administered. This may be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",3
Interventions,PR,N/A,N/A,4,PRYN,Any Procedures Performed,An indication whether or not 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 aCRF is annotated to indicate 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 preprinted on the CRF.",PRCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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 preprinted on the CRF.",PRSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,(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 PRTERM 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 column with the heading SDTMIG Target.,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 prespecified on a CRF.,N/A,N/A,Char,O,N/A,PRPRESP,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(NY),N/A,"For prespecified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the SDTM dataset creation. If a study collects both prespecified interventions as well as 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 whether a prespecified 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 column with the heading SDTMIG Target. 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 of 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 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 of 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 column with the heading SDTMIG Target.,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. \n 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 SDTMIG v3.2 Section 4.1.4.7 for more information. for 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. \n 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 v3.2 Section 4.1.4.7 for more information. for 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 column with the heading SDTMIG Target.,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 Adverse Events 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 SDTMIG v3.2 Section 8.2 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 Medical History 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 SDTMIG v3.2 Section 8.2 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 column with the heading SDTMIG Target.,(UNIT),N/A,"When sponsors collect data for amount of [PRTRT] performed or administered, Unit should be collected as well (if 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,(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, such as 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,(LAT),N/A,Further details the laterality of the location where the procedure was administered/taken. This may be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,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 whether or not 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 is annotated to indicate 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 or explanation of 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 column with the heading SDTMIG Target.,N/A,N/A,"Captures reason [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 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 non-standard variables 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 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 aCRF is annotated to indicate 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 indication of 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 non-standard variables 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 non-standard variables 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 non-standard variables 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,MedDRA 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 non-standard variables 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 the MedDRA coding dictionary. 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,MedDRA Lowest Level Term code.,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 non-standard variables 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 the MedDRA coding dictionary. 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,MedDRA 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 non-standard variables 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 the MedDRA coding dictionary. 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,MedDRA text description of High Level Term from the primary path.,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 non-standard variables 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 the MedDRA coding dictionary. 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,MedDRA High Level Term code from the primary path.,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 non-standard variables 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 the MedDRA coding dictionary. 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,MedDRA text description of the High Level Group Term from the primary path.,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 non-standard variables 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 the MedDRA coding dictionary. 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,MedDRA High Level Group Term code from the primary path.,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 non-standard variables 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 the MedDRA coding dictionary. 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,MedDRA Primary System Organ Class description associated with the intervention.,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 non-standard variables 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 the MedDRA coding dictionary. 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,MedDRA Primary System Organ Class code.,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 non-standard variables 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 the MedDRA coding dictionary. 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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 preprinted 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 preprinted on the CRF.",SUCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 preprinted 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 self-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 preprinted on the CRF.",SUSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. The value for subcategory may be preprinted 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 column with the heading SDTMIG Target.,(NY),N/A,"For prespecified interventions, a hidden field on a CRF defaulted to Y, or added during the SDTM dataset creation. If a study collects both prespecified interventions as well as 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 whether or not 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 is annotated to indicate 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 or not there is data to record.,8
Interventions,SU,N/A,N/A,9,SUNCF,Never Current Former Usage,Indication the prespecified 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 the SDTM-based datasets are created. 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"" such as 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 preprinted 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 column with the heading SDTMIG Target. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Since 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.",10
Interventions,SU,N/A,N/A,11,SUREASND,Reason Substance Use Not Collected,An explanation of why the 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 column with the heading SDTMIG Target.,N/A,N/A,"The reason the 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 ounces).",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 preprinted 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 column with the heading SDTMIG Target.,(FREQ),N/A,"When possible, the options for dose/amount frequency are preprinted 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,The sponsor-defined options should be preprinted 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target. 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 WHODrug, or a term in SNOMED, ICD9, or other published 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
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted for the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",3
Events,AE,N/A,N/A,4,AEYN,Any Adverse Event,An indication whether or not 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 aCRF is annotated to indicate 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 preprinted on the CRF.",AECAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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
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 preprinted on the CRF.",AESCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 prespecified 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 column with the heading SDTMIG Target.,N/A,N/A,"Can be represented either as an open-entry field to capture verbatim terms reported by subjects or could be preprinted 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 such as MedDRA or 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 whether a prespecified adverse event or a group of adverse events occurred when information about the occurrence of a specific event is solicited.,Did the subject have [prespecified 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 prespecified 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 prespecified 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,prespecified Adverse Event,"An indication that a specific event, or group of events, are prespecified on a CRF.",N/A,N/A,Char,O,N/A,AEPRESP,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(NY),N/A,"A hidden field on a CRF defaulted to ""Y"", or added during SDTM-based dataset creation, when the AE is prespecified. Null for spontaneously reported events. If a study collects both prespecified adverse events as well as free-text events, the value of AEPRESP should be ""Y"" for all prespecified 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 AE 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 AE.,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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 events.,AEDIR,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(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 the 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 AE 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 AE 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 AE to similar type events observed in clinical practice. Severity is not equivalent to seriousness.,AESEV,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(AESEV),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 guidelines for Clinical Study Reports.,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 column with the heading SDTMIG Target. 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,"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 guidelines for CSR. 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 whether or not 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 an adverse event should be classified as serious based on the serious criteria defined in the protocol.,AESER,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(NY),N/A,"This field is related to the individual serious adverse event type fields, which may or may not be collected on the CRF. Either AESER or all the Adverse Serious type fields must be present on the CRF. The sponsor should check if the regulatory agencies to which the data will be submitted require 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 column with the heading SDTMIG Target.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require 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,"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, 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 column with the heading SDTMIG Target.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require 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 column with the heading SDTMIG Target.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require 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 column with the heading SDTMIG Target.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require 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 column with the heading SDTMIG Target.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require 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 in SDTM domains.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require 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 column with the heading SDTMIG Target.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require 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 column with the heading SDTMIG Target.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require the collection of this data. ""Involves cancer"" (AESCAN) and ""Occurred with overdose"" (AESOD) are not part of the ICH definition of a serious adverse event, 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 occurs with an overdose.,AESOD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(NY),N/A,"If the details regarding Serious AEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each Serious AE type. Sponsors may only collect the AESER field because the individual serious adverse event types might be collected in a separate pharmacovigilance database and therefore are not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require the collection of this data. ""Involves cancer"" (AESCAN) and ""Occurred with overdose"" (AESOD) are not part of the ICH definition of a serious adverse event, 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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsored-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.",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 column with the heading SDTMIG Target.,(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 a sponsor-specific decision. 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 for Medical Devices 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 the action 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 non-standard variables in SDTM domains.,N/A,N/A,"Sponsor-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 adverse event.,AEACNOTH,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"This field 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 column with the heading SDTMIG Target.,(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. Since 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 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 AE 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 Adverse Event to the Disposition record (see SDTMIG v3.2 Section 8.2). 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 non-standard variables in SDTM domains.",(NY),N/A,"Because the Action Taken field was defined to only collect the 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 aCRF is annotated to indicate 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 drug.,AERELNST,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 aCRF is annotated to indicate 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 non-standard variables 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 AE, check the pattern of the AE. If a single event, choose single.",AEPATT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 Trtmnt Given,Char,O,"Indicate if any non-study treatments were received because of this adverse event. If ""Yes"" is answered for this question, 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 column with the heading SDTMIG Target.,(NY),N/A,"If medication data are reported, the CMAENO variable (on the ConMed CRF) may be used to collect the associated AE Identifier in order to populate RELREC. If procedures are reported, the PRAENO variable (on the Procedures 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.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 Code,MedDRA 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 column with the heading SDTMIG Target. 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,MedDRA Lowest Level Term code.,N/A,N/A,Num,R/C,N/A,AELLTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA code for the Preferred Term.,N/A,N/A,Num,R/C,N/A,AEPTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA text description of the High Level Term from the primary path.,N/A,N/A,Char,R/C,N/A,AEHLT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA High Level Term code from the primary path.,N/A,N/A,Num,R/C,N/A,AEHLTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA text description of the High Level Group Term from the primary path.,N/A,N/A,Char,R/C,N/A,AEHLGT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA High Level Group Term code from the primary path.,N/A,N/A,Num,R/C,N/A,AEHLGTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA Primary System Organ Class text description associated with the event.,N/A,N/A,Char,R/C,N/A,AESOC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.,53
Events,AE,N/A,N/A,54,AESOCCD,AE Primary System Organ Class Code,MedDRA code for the primary System Organ Class.,N/A,N/A,Num,R/C,N/A,AESOCCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.,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 adverse event. If yes, briefly describe these actions.",N/A,Does not map to an SDTMIG variable. The SDTM aCRF is annotated to indicate 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 column with the heading SDTMIG Target.,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,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 preprinted on the CRF.",CECAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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
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 preprinted on the CRF.",CESCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 whether or not 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 aCRF is annotated to indicate 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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 prespecified 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 column with the heading SDTMIG Target.,N/A,N/A,"Can be represented either as an open-entry field to capture verbatim terms reported by subjects or could be preprinted in the situation where solicited CEs of interest are captured. May be used as Specify Other field to collect more details on a prespecified 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 such as MedDRA or 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 whether a prespecified clinical event or a group of clinical events occurred when information about the occurrence of a specific event is solicited.,Did the subject have [prespecified 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 column with the heading SDTMIG Target.,(NY),N/A,The CDASH variable CEOCCUR is used to report the occurrence of a prespecified 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 response was not asked or answered.,9
Events,CE,N/A,N/A,10,CEPRESP,Clinical Event prespecified,"An indication that a specific event, or group of events, are prespecified on a CRF.",N/A,N/A,Char,O,N/A,CEPRESP,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 prespecified. Null for spontaneously reported events. If a study collects both prespecified clinical events as well as free-text events, the value of CEPRESP should be ""Y"" for all prespecified 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,O,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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 anatomical location of the clinical event.,CEPORTOT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 such as CEENRF or CEENRTPT. When populating CEENRF, if the value of CEONGO is ""Y"", the value 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,O,"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 column with the heading SDTMIG Target. 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,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 column with the heading SDTMIG Target. 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 column with the heading SDTMIG Target. 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,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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target. 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,MedDRA 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 column with the heading SDTMIG Target. 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,MedDRA Lowest Level Term code.,N/A,N/A,Num,O,N/A,CELLTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA code for the Preferred Term.,N/A,N/A,Num,O,N/A,CEPTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA text description of the High Level Term from the primary path.,N/A,N/A,Char,O,N/A,CEHLT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA High Level Term code from the primary path.,N/A,N/A,Num,O,N/A,CEHLTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA text description of the High Level Group Term from the primary path.,N/A,N/A,Char,O,N/A,CEHLGT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA High Level Group Term code from the primary path.,N/A,N/A,Num,O,N/A,CEHLGTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA Primary System Organ Class description associated with the event.,N/A,N/A,Char,O,N/A,CESOC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.,32
Events,CE,N/A,N/A,33,CESOCCD,CE Primary System Organ Class Code,MedDRA code for the primary System Organ Class.,N/A,N/A,Num,O,N/A,CESOCCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.,33
Events,DS,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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,DS,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",2
Events,DS,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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",3
Events,DS,N/A,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 column with the heading SDTMIG Target.,(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.",4
Events,DS,N/A,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 column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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. DSSCAT can only be used if there is an DSCAT with a and it must be a subcategorization of the Disposition event.,5
Events,DS,N/A,N/A,6,EPOCH,Epoch,"Trial epoch (e.g., DOUBLE BLIND, SINGLE BLIND, 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 column with the heading SDTMIG Target.,(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 preprinted on the CRF as the title of the page; however, some companies have a standard CRF module that includes a pick-list of epochs. See SDTMIG for further information regarding EPOCH. EPOCH would only be populated for disposition event and not for protocol milestones.",6
Events,DS,N/A,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 column with the heading SDTMIG Target. 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 preprinted 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 hence 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. \n",7
Events,DS,N/A,N/A,8,DSTERM,Reported Term for the Disposition Event,The verbatim or prespecified name of the event. The reported or prespecified 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 column with the heading SDTMIG Target. 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 an 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.",8
Events,DS,N/A,N/A,9,DSSTDAT,Disposition Event Start Date,"The date of the specified protocol milestone (e.g., informed consent, randomization) or disposition event (e.g., study completion or discontinuation), represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the [protocol milestone/disposition event/other event name] date?,[Protocol Milestone/Disposition Event/Other Event Name] Date,Char,R/C,Record the date of [protocol milestone/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,"Define in the protocol and/or CRF completion instructions the criteria for completion of each protocol milestone or disposition event for which a disposition CRF will be provided. Only collect the date of each protocol milestone or 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 form, then this field would not be collected on the Disposition CRF module. If not collected elsewhere, this field should be collected on the Disposition CRF module.",9
Events,DS,N/A,N/A,10,DSSTTIM,Disposition Event Start Time,"The time of the specified protocol milestone (e.g., informed consent, randomization) or disposition event (e.g., study completion or discontinuation), represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [protocol milestone/disposition event/other event name] time?,[Protocol Milestone/Disposition Event/Other Event Name] 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,"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 form, then this field would not be collected on the Disposition CRF module.",10
Events,DS,N/A,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 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
Events,DS,N/A,N/A,12,DSUNBLND,Unblinded,An indication 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 AE, or unintentionally for other reasons (e.g., an administrative action) during the subject's blinded/masked treatment. Record the primary reason for discontinuation if the unblinding resulted in the subject discontinuing the trial prematurely.",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,"There may be multiple rows in the SDTM DS dataset to represent this information, each with the appropriate DSCAT values. One row could indicate the treatment was unblinded using DSCAT=""OTHER EVENT"" and another row could indicate the status of the subject at the end of participation in the trial using DSCAT= ""DISPOSITION"". 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 sponsor-defined standardized text (e.g., TREATMENT UNBLINDED). If DSUNBLND is ""Yes"", and the unblinding also resulted in the subject discontinuing the trial prematurely, populate DSCAT with ""DISPOSTION"" and use the SDTM IG variables DSTERM and DSDECOD to capture the applicable discontinuation details. If the unblinding occurred due to an Adverse Event, DSTERM contains the text of the AE, and in the AE domain the SDTMIG variable AEACNOTH ""Were any other actions taken in response to this adverse event?"" may include text of ""Treatment Unblinded"". DSUNBLND may also be used to document intentional unblinding at a protocol defined point in the trial.",12
Events,DS,N/A,N/A,13,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 question to aid in monitoring and data cleaning, and usually not submitted in a SUPPDS dataset.",13
Events,DS,N/A,N/A,14,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 since the mapping depends on the situation (next epoch or 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.",14
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted for the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 preprinted on the CRF.",DVCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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
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 preprinted on the CRF.",DVSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 whether or not 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 aCRF is annotated to indicate 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. \n,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 column with the heading "SDTMIG Targe".,N/A,N/A,"DVTERM and DVDECOD may have the same value. If the CRF is collecting protocol deviations using a code list of responses, then DVDECOD should be used to store the code list 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 code list 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 prespecified 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 column with the heading SDTMIG Target.,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 and 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 and 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 and 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 and 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 preprinted 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 column with the heading SDTMIG Target. 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"While 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,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",3
Events,HO,N/A,N/A,4,HOYN,Any Healthcare Encounters,An indication whether or not 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 is annotated to indicate 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.,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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. 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 column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 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 column with the heading SDTMIG Target.,(NY),N/A,The CDASH variable HOOCCUR is used is used to report the occurrence of a prespecified healthcare encounter. HOOCCUR is not used if the healthcare encounters are collected on the CRF in a manner that requires a free-flow 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,prespecified Healthcare Encounter,"An indication that a specific event, or group of events, are prespecified on a CRF.",N/A,N/A,Char,O,N/A,HOPRESP,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 prespecified. Null for spontaneously reported events. If a study collects both prespecified 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 of why the data are not available.,What was the reason the data was 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 column with the heading SDTMIG Target.,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 preprinted 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 column with the heading SDTMIG Target. 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.",10
Events,HO,N/A,N/A,11,HOTERM,Reported Term for Healthcare Encounter,The reported or prespecified 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,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, (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, (date 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 preprinted on the (e)CRF. If only one 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 such as HOENRF or HOENRTPT. When populating HOENRF, if the value of HOONGO is ""Y"", the value 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 the 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 v3.2 Section 4.1.4.7 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 preprinted 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,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 such as HOMHNO can be created as needed. See SDTMIG v3.2 Section 8.2 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",3
Events,MH,N/A,N/A,4,MHYN,Any Medical History Event,An indication whether or not 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 is annotated to indicate 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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology (e.g., CARDIAC, GENERAL). This would most commonly be either a heading or a preprinted 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. 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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 the 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 pre-print these values on the CRF or use them as defaulted or hidden text.,SUPPMH.QVAL,This field does not map directly to an SDTM variable. This information could be submitted in a SUPPMH dataset as the value of SUPPMH.QVAL when SUPPMH.QNAM = "MHEVDTYP" and SUPPMH.QLABEL= "Medical History Event Date Type". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,N/A,N/A,"The type of start/ and or end date (e.g., DIAGNOSIS, EPISODE, EXACERBATION, SYMPTOM ONSET). It is not related to the trial's condition. This date type cannot be a PRIMARY DIAGNOSIS, SECONDARY DIAGNOSIS since 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 prespecified 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 column with the heading SDTMIG Target.,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 prespecified surgeries, or procedures should be collected in the PR domain.",10
Events,MH,N/A,N/A,11,MHOCCUR,Medical History Occurrence,An indication whether a prespecified 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 column with the heading SDTMIG Target.,(NY),N/A,MHOCCUR is used to report the occurrence of a prespecified 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 response 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 prespecified on a CRF.",N/A,N/A,Char,O,N/A,MHPRESP,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 prespecified medical history as well as free-text events, the value of MHPRESP should be ""Y"" for all prespecified 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 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 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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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, which means 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target. 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 fieldthat 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,MedDRA Dictionary 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 column with the heading SDTMIG Target. 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,MedDRA Lowest Level Term code.,N/A,N/A,Num,O,N/A,MHLLTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA code for the Preferred Term.,N/A,N/A,Num,O,N/A,MHPTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA text description of the High Level Term from the primary path.,N/A,N/A,Char,O,N/A,MHHLT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA High Level Term code from the primary path.,N/A,N/A,Num,O,N/A,MHHLTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA text description of the High Level Group Term from the primary path.,N/A,N/A,Char,O,N/A,MHHLGT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA High Level Group Term code from the primary path.,N/A,N/A,Num,O,N/A,MHHLGTCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MedDRA Primary System Organ Class description associated with the event.,N/A,N/A,Char,O,N/A,MHSOC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MH,N/A,N/A,32,MHSOCCD,MH Event Primary System Organ Class Code,MedDRA code for the primary System Organ Class.,N/A,N/A,Num,O,N/A,MHSOCCD,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 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 column with the heading SDTMIG Target.,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 whether or not 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 v3.2 Section 4.1.5.1.2.",(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 CDASH variable name is an example of what ""variable name"" 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 column with the heading SDTMIG Target.,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 preprinted on the CRF. If DACAT is not collected (e.g., it is self-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 v3.2 Section 6.3.8.2 for examples on populating DACAT and DASCAT. This CDASH variable name is an example of what ""variable name"" 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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. If it is known at the time of data collection, the treatment name may be collected in DASCAT (with appropriate, but different than, DACAT grouping values). 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 Section 6.3 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 column with the heading SDTMIG Target. May be used to create RELREC to link this record with a record in EX domain.,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. In this situation, sponsors may need to use additional variables. This CDASH variable name is an example of what ""variable name"" 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 for all the observations when they are performed on the same date. The date of each observation can also be collected using a 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 CDASH variable name is an example of what "variable name" 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 column with the heading SDTMIG Target. 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 the 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 CDASH variable name is an example of what ""variable name"" 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 preprinted on CRF.",DAORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),(DAORRESU),The unit should be preprinted on the CRF or a field provided on the CRF to capture it. This CDASH variable name is an example of what "variable name" 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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, see SDTM Table 2.2.4.",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 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 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 whether or not 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 Section 4.1.5.1.2.",(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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 preprinted 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 for examples on 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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be preprinted 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. If it is known at the time of data collection, the treatment name may be collected in DASCAT (with appropriate, but different, than DACAT grouping values). See SDTMIG DA domain 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.",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 column with the heading SDTMIG Target.,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. 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. 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 preprinted 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 column with the heading SDTMIG Target. 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 be preprinted 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 header. 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 column with the heading SDTMIG Target.,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 preprinted on CRF.",DAORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),(DAORRESU),"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text.",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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. 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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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.,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 preprinted on the CRF.",DDCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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.,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 preprinted on the CRF.",DDSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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 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 question regarding whether or not any death details were 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 is annotated to indicate 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.,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 preprinted 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 column with the heading SDTMIG Target. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Since 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.",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, as deemed appropriate by the sponsor (e.g., DS).",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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a preprinted, 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted for the CRFs that are shipped to each site. 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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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 Study Data Tabulation Model, Table 2.2.4.",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 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 question regarding whether or not any death details were 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 is annotated to indicate 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 preprinted on the CRF.",DDCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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.",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 preprinted on the CRF.",DDSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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 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, as deemed appropriate by the sponsor (e.g., DS).",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 column with the heading SDTMIG Target. 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 CDASH variable name is an example of what ""variable name"" 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 column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a preprinted, 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 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 preprinted on the CRF.",EGCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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
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 preprinted on the CRF.",EGSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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.",7
Findings,EG,Central Reading,N/A,8,EGPERF,ECG Performed,"An indication whether or not 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 v3.2 Section 4.1.5.1.2.",(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,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 column with the heading SDTMIG Target. 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).",9
Findings,EG,Central 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 column with the heading SDTMIG Target.,(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 one 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.",10
Findings,EG,Central Reading,N/A,11,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 column with the heading SDTMIG Target.,(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 one 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.",11
Findings,EG,Central Reading,N/A,12,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.",12
Findings,EG,Central Reading,N/A,13,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 preprinted on the CRF.",EGTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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 preprinted 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 header.",13
Findings,EG,Central Reading,N/A,14,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.,14
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",15
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",16
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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",17
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 column with the heading SDTMIG Target.,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.",18
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 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 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.",19
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 preprinted on the CRF.",EGCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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.",20
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 preprinted on the CRF.",EGSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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.",21
Findings,EG,Local Reading,N/A,8,EGPERF,ECG Performed,"An indication of whether or not 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 v3.2 Section 4.1.5.1.2.",(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.",22
Findings,EG,Local Reading,N/A,9,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 column with the heading SDTMIG Target.,(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 one 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.",23
Findings,EG,Local Reading,N/A,10,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 column with the heading SDTMIG Target.,(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 one 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.",24
Findings,EG,Local Reading,N/A,11,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.",25
Findings,EG,Local Reading,N/A,12,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 preprinted on the CRF.",EGTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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 point are needed to differentiate multiple sequential assessments. It is recommended that time points should be preprinted 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 header.",26
Findings,EG,Local Reading,N/A,13,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.,27
Findings,EG,Local Reading,N/A,14,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 preprinted 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 preprinted 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 header.",28
Findings,EG,Local Reading,N/A,15,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 column with the heading SDTMIG Target.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,29
Findings,EG,Local Reading,N/A,16,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 preprinted on CRF.",EGORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),(EGORRESU),"May be included if quantitative results are recorded. Because units for quantitative ECG results are typically limited, units should be preprinted on the CRF with the associated test when possible, rather than having the sites record the units. This item is not necessary for qualitative results.",30
Findings,EG,Local Reading,N/A,17,EGCLSIG,ECG Clinical Significance,An indication 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.,31
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",32
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",33
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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",34
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 column with the heading SDTMIG Target.,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.",35
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 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 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.",36
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 preprinted on the CRF.",EGCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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.",37
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 preprinted on the CRF.",EGSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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.",38
Findings,EG,Central Reading with Investigator Assessment,N/A,8,EGPERF,ECG Performed,"An indication of whether or not 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 v3.2 Section 4.1.5.1.2.",(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.",39
Findings,EG,Central Reading with Investigator Assessment,N/A,9,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 column with the heading SDTMIG Target. 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. (e.g., Universally Unique Identifier (UUID) for external waveform file, session number automatically generated by electronic equipment). This can also be used to link.",40
Findings,EG,Central Reading with Investigator Assessment,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 column with the heading SDTMIG Target.,(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 one 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.",41
Findings,EG,Central Reading with Investigator Assessment,N/A,11,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 column with the heading SDTMIG Target.,(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 one 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.",42
Findings,EG,Central Reading with Investigator Assessment,N/A,12,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.",43
Findings,EG,Central Reading with Investigator Assessment,N/A,13,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 preprinted on the CRF.",EGTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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 preprinted 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 header.",44
Findings,EG,Central Reading with Investigator Assessment,N/A,14,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.,45
Findings,EG,Central Reading with Investigator Assessment,N/A,15,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 column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be preprinted or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",46
Findings,EG,Central Reading with Investigator Assessment,N/A,16,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.,47
Findings,EG,Central Reading with Investigator Assessment,N/A,17,EGCLSIG,ECG Clinical Significance \n,An indication 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 non-standard variables 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.",48
Findings,EG,Central Reading with Investigator Assessment,N/A,18,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,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 Medical History 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 SDTMIG v3.2 Section 8.2 for information on RELREC.,49
Findings,EG,Central Reading with Investigator Assessment,N/A,19,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,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 Adverse Events 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 SDTMIG v3.2 Section 8.2 for information on RELREC.,50
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 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 aCRF is annotated to indicate 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,Record whether the criterion exception was Inclusion or Exclusion. Checkbox: Check Inclusion or Exclusion.,IECAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 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 column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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 This can be used to distinguish criteria for a sub-study or to categorize the criteria 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 column with the heading SDTMIG Target.,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 v3.2 Section 7.5.2 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 preprinted 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 column with the heading SDTMIG Target. 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 column with the heading SDTMIG Target.,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 Criteria is not met, IEORRES is mapped to ""N"" and when an Exclusion Criteria 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 tests 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.",5
Findings,LB,Central Processing,N/A,6,LBPERF,Lab Performed,"An indication of whether or not 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 v3.2 Section 4.1.5.1.2.",(NY),N/A,"This may be implemented for an Lab entire panel, or on a specific lab test basis. 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 date of the lab specimen collection?,Collection Date,Char,R/C,Record the 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 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?,[Start] Collection Time,Char,R/C,Record 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 preprinted on the CRF.",LBCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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. 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 preprinted on the CRF.",LBSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology (e.g. Electrolytes, Liver Function). This would most commonly be preprinted 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. 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 preprinted on the CRF.",LBTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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 preprinted 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 header.",11
Findings,LB,Central Processing,N/A,12,LBCOND,Lab Test Condition Met,"Indication whether the testing condition 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 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 preprinted 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 column with the heading SDTMIG Target.,(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 such as 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 column with the heading SDTMIG Target. 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 tests 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 or not 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 v3.2 Section 4.1.5.1.2.",(NY),N/A,"This may be implemented for an entire lab panel, or on a specific lab test basis. 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 date of the lab specimen collection,Collection Date,Char,R/C,Record the 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 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?,[Start] Collection Time,Char,R/C,Record 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 one 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 preprinted on the CRF.",LBCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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. 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 preprinted on the CRF.",LBSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology (e.g. Electrolytes, Liver Function). This would most commonly be preprinted 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. 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 preprinted on the CRF.",LBTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. See 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 preprinted 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 header.",25
Findings,LB,Central Processing with CS,N/A,12,LBCOND,Lab Test Condition Met,"Indication whether the testing condition 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 non-standard variables 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 preprinted 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 column with the heading SDTMIG Target.,(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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 header.",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 laboratory test result.,LBORRES,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,(UNIT),N/A,Optional if already provided from central lab or a sponsor stored 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 non-standard variables 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 column with the heading SDTMIG Target. 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 LBDTC in ISO 8601 format.",N/A,N/A,"The date of the laboratory tests 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 or not 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 v3.2 Section 4.1.5.1.2.",(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 date of the lab specimen collection?,Collection Date,Char,R/C,Record the 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?,[Start] Collection Time,Char,R/C,Record 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 one 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 preprinted on the CRF.",LBCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. 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 preprinted on the CRF.",LBSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. 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 preprinted on the CRF.",LBTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. See 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 preprinted 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 header.",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 column with the heading SDTMIG Target.,(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 whether the testing condition 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 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 preprinted 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 condition of specimen.,LBSPCCND,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 header.",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 laboratory test result.,LBORRES,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,(METHOD),N/A,"This information may be collected when more than one 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 preprinted on CRF.",LBORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text. 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 preprinted 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 column with the heading SDTMIG Target. 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 codes lists (TOXGRV3) and (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 column with the heading SDTMIG Target. 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,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 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,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 column with the heading SDTMIG Target.,(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 non-standard variables 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 column with the heading SDTMIG Target.,N/A,N/A,Recommended to collect on the CRF if lab names 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted for the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 MBDTC in ISO 8601 format.",N/A,N/A,"The date that the Microbiology Findings 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 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 or not a planned measurement, 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 microbiology specimen was collected,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 v3.2 Section 4.1.5.1.2.",(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 column with the heading SDTMIG Target. 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,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?,Collection Date,Char,R/C,Record the 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 collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",8
Findings,MB,Central Processing,N/A,9,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?,Collection Time,Char,R/C,Record 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.,9
Findings,MB,Central Processing,N/A,10,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 preprinted on the CRF.",MBCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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,MB,Central Processing,N/A,11,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 preprinted on the CRF.",MBSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. MBSCAT can only be used if there is an MBCAT and it must be a subcategorization of MBCAT.",11
Findings,MB,Central Processing,N/A,12,MBSPEC,MB 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.,MBSPEC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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,MB,Central Processing,N/A,13,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 column with the heading SDTMIG Target.,(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,MB,Central Processing,N/A,14,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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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.",14
Findings,MB,Central Processing,N/A,15,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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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,MB,Central Processing,N/A,16,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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",17
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",18
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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",19
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 column with the heading SDTMIG Target.,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.",20
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 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 MBDTC in ISO 8601 format.",N/A,N/A,"The date that the Microbiology Specimen was 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 collection date can be included on the Microbiology Findings CRF using the date (MBDAT) field.",21
Findings,MB,Local Processing,N/A,6,MBPERF,Microbiology Sampling Performed,"An indication of whether or not a planned measurement, series of measurements, test, or observation was performed or specimen was collected.",Was the microbiology examination performed?,Microbiology Examination Performed,Char,O,Indicate whether or not microbiology examination 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 SDTMIG v3.2 Section 4.1.5.1.2.",(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.,22
Findings,MB,Local 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 column with the heading SDTMIG Target. 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,MB,Local Processing,N/A,8,MBSPID,MB Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, This is typically used for preprinted 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.",MBSPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,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, sponsor may insert instructions to ensure each microbiology specimen or result record has a unique identifier that will link records across domains.",MBGRPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"SDTMIG v3.2 uses --GRPID as the variable that links the Microbiology Specimen/Result domain (MB) with the Microbiology Susceptibility domain (MS). In RELREC, this one-to-many relationship may be represented with a simple 2-record dataset-to-dataset RELREC.",25
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, 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 SDTM variable listed in the column with the heading "SDTM Target". 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).",26
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?,Collection Date,Char,R/C,Record the 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 collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",27
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?,Collection Time,Char,R/C,Record 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.,28
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 microscopic finding category, if not preprinted on the CRF.",MBCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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.",29
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 microscopic finding subcategory, if not preprinted on the CRF.",MBSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. MBSCAT can only be used if there is an MBCAT and it must be a subcategorization of MBCAT.",30
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 microscopic examination, if not preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 header.",31
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 preprinted on the CRF.",MBTSTDTL,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Provides additional details for the microbiology examination. It is recommended that the test detail be preprinted 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.",32
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 column with the heading SDTMIG Target.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,33
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 preprinted on CRF.",MBORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text. 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"").",34
Findings,MB,Local Processing,N/A,19,MBCLSIG,MB 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.,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,35
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 column with the heading SDTMIG Target.,N/A,N/A,"Used to categorize the results of a finding (e.g., INFECTING, COLONIZER).",36
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 column with the heading SDTMIG Target.,N/A,N/A,Recommended to collect on the CRF if lab names was not collected at the site/study level or if multiple labs are used by a site.,37
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 column with the heading SDTMIG Target.,(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.",38
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 condition of specimen.,MBSPCCND,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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.,39
Findings,MB,Local Processing,N/A,24,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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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.",40
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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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,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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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.,42
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 column with the heading SDTMIG Target.,(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.",43
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 column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a preprinted, or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",44
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 MIDTC in ISO 8601 format.",N/A,N/A,"The date the Microscopic Findings 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 Microscopic Findings CRF using the date (MIDAT) field.",5
Findings,MS,Central Processing,N/A,6,MSPERF,MS Test Performed,"An indication of whether or not 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 v3.2 Section 4.1.5.1.2.",(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 column with the heading SDTMIG Target. 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?,Test Date,Char,R/C,Record the 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 collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required.",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?,Susceptibility Test Time,Char,R/C,Record 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 one 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,"Record the microbiology susceptibility category, if not preprinted on the CRF.",MSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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,"Record the microbiology susceptibility subcategory, if not preprinted on the CRF.",MSSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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 column with the heading SDTMIG Target.,(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 condition of specimen.,MSSPCCND,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",19
Findings,MS,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 column with the heading SDTMIG Target.,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.",20
Findings,MS,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 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 MIDTC in ISO 8601 format.",N/A,N/A,"The date of Microscopic Findings 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 Microscopic Findings CRF using the date (MSDAT) field.",21
Findings,MS,Local Processing,N/A,6,MSPERF,MS Susceptibility Test Performed,"An indication of whether or not 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 Section 4.1.5.1.2.",(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.,22
Findings,MS,Local 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 column with the heading SDTMIG Target. 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,MS,Local Processing,N/A,8,MSSPID,MS Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, This is typically used for preprinted 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.",MSSPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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,MS,Local Processing,N/A,9,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, sponsor may insert instructions to ensure each microbiology susceptibility result has an identifier that will link records across domains.",MSLNKID,Maps directly to the SDTM variable listed in the column with the heading "SDTM Target". 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).",25
Findings,MS,Local Processing,N/A,10,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?,Collection Date,Char,R/C,Record the 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 collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required.",26
Findings,MS,Local Processing,N/A,11,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?,Collection Time,Char,R/C,Record 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 one day or when the timing in relationship to study treatment is required for analysis.,27
Findings,MS,Local Processing,N/A,12,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,"Record the microscopic finding category, if not preprinted on the CRF.",MBCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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.",28
Findings,MS,Local Processing,N/A,13,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,"Record the microscopic finding subcategory, if not preprinted on the CRF.",MSSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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.",29
Findings,MS,Local Processing,N/A,14,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 microscopic examination, if not preprinted 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 column with the heading SDTMIG Target. 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.,(MBTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be preprinted 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 header.",30
Findings,MS,Local Processing,N/A,15,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 preprinted on the CRF.",MSTSTDTL,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 preprinted 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.",31
Findings,MS,Local Processing,N/A,16,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 column with the heading SDTMIG Target.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,32
Findings,MS,Local Processing,N/A,17,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,"Record or select the original unit in which these data were collected, if not preprinted on CRF.",MSORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text. 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).",33
Findings,MS,Local Processing,N/A,18,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,34
Findings,MS,Local Processing,N/A,19,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 column with the heading SDTMIG Target.,N/A,N/A,"Used to categorize the results of a finding (e.g., ""SUSCEPTIBLE"", ""RESISTANT"").",35
Findings,MS,Local Processing,N/A,20,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 column with the heading SDTMIG Target.,N/A,N/A,Recommended to collect on the CRF if lab names was not collected at the site/study level or if multiple labs are used by a site.,36
Findings,MS,Local Processing,N/A,21,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 column with the heading SDTMIG Target.,(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.",37
Findings,MS,Local Processing,N/A,22,MSSPCCND,MS Specimen Condition,Describes the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,O,Record condition of specimen.,MSSPCCND,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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.,38
Findings,MS,Local Processing,N/A,23,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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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.",39
Findings,MS,Local Processing,N/A,24,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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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.,40
Findings,MS,Local Processing,N/A,25,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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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.,41
Findings,MS,Local Processing,N/A,26,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 column with the heading SDTMIG Target.,(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.",42
Findings,MS,Local Processing,N/A,27,MSEVAL,MS 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).",MSEVAL,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be preprinted or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",43
Findings,MS,Local Processing,N/A,28,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 a non-host organism that is the subject of the test.,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="NHOID" and SUPPMS.QLABEL="Non-host Organism ID". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,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. These variables were added as core SDTM variables in SDTMIG v3.3.,44
Findings,MS,Local Processing,N/A,29,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.,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="MSAGENT" and SUPPMS.QLABEL= "Microbiology Susceptibility Agent". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,N/A,N/A,These variables were added as core SDTM variables in SDTMIG v3.3.,45
Findings,MS,Local Processing,N/A,30,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.,SUPPMS.QVAL,This does not map directly to an SDTMIG variable. This information could be submitted in a SUPPMS.QVAL where SUPPMS.QNAM="MSCONC" and SUPPMS.QLABEL="MS Agent Concentration". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,N/A,N/A,These variables were added as core SDTM variables in SDTMIG v3.3.,46
Findings,MS,Local Processing,N/A,31,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.,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="MSCONCU" and SUPPMS.QLABEL="MS Agent Concentration Unit". Refer to the current SDTM and SDTMIG for instructions on placement of non-standard variables in SDTM domains.,N/A,N/A,These variables were added as core SDTM variables in SDTMIG v3.3.,47
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 MIDTC in ISO 8601 format.",N/A,N/A,"The date the Microscopic Findings 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 Microscopic Findings CRF using the date (MIDAT) field.",5
Findings,MI,Central Processing,N/A,6,MIPERF,Microscopic Examination Performed,"An indication of whether or not 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 v3.2 Section 4.1.5.1.2.",(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 column with the heading SDTMIG Target. 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 date of the specimen collection?,Collection Date,Char,R/C,Record the 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 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?,Collection Time,Char,R/C,Record 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 preprinted on the CRF.",MICAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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 preprinted on the CRF.",MISCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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 column with the heading SDTMIG Target.,(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 condition of specimen.,MISPCCND,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 MIDTC in ISO 8601 format.",N/A,N/A,"The date the Microscopic Findings 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 Microscopic Findings CRF using the date (MIDAT) field.",21
Findings,MI,Local Processing,N/A,6,MIPERF,Microscopic Examination Performed,"An indication of whether or not 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 v3.2 Section 4.1.5.1.2.",(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 column with the heading SDTMIG Target. 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 preprinted 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.",MISPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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 date of the specimen collection?,Collection Date,Char,R/C,Record the 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 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?,Collection Time,Char,R/C,Record 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 preprinted on the CRF.",MICAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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 preprinted on the CRF.",MISCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 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 preprinted on the CRF.",MITSTDTL,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(MIFTSDTL),N/A,"Provides additional details for the microscopic examination. It is recommended that the test detail be preprinted 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 test result, interpretation or finding.",MIORRES,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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,"Record or select the original unit in which these data were collected, if not preprinted on CRF.",MIORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text. 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 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,N/A,N/A,Recommended to collect on the CRF if lab names 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 column with the heading SDTMIG Target.,(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 condition of specimen.,MISPCCND,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(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.",41
Findings,MI,Local Processing,N/A,26,MIEVAL,MI 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).",MIEVAL,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a preprinted or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",42
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 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 whether or not 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 v3.2 Section 4.1.5.1.2.",(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,The variable used to indicate that data are not available by having the site recording the value as "Not Done".,Record Not Done ifthe 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 column with the heading SDTMIG Target.,(ND),N/A,"A Not Done check box, which indicates the test was ""NOT DONE"". Typically, there would be one check box 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 of 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 column with the heading SDTMIG Target.,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) and 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 aCRF is annotated to indicate that this field is NOT SUBMITTED.,N/A,N/A,"When a series of specimen are taken 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 check box.",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 point 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 preprinted 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 column with the heading SDTMIG Target. See 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 preprinted 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 header.",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 column with the heading SDTMIG Target.,(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 while the subject was fasted.,13
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,14,PCCOND,PK Sampling 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.,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 preprinted 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, or 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 column with the heading SDTMIG Target. 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 preprinted on the CRF.",PCSPEC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 preprinted 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 column with the heading SDTMIG Target. 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 the analyte test results are collected on the CRF, the test would be the analyte name. It is recommended that the test names be preprinted 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 header.",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 column with the heading SDTMIG Target.,N/A,N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text.",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,"Record or select the original unit in which these data were collected, if not preprinted on CRF.",PCORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text.",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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 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 whether or not PK samples were collected.,Were PK samples collected?,Collected,Char,O,Indicate that 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 v3.2 Section 4.1.5.1.2.",(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 of 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 column with the heading SDTMIG Target.,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 point 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 preprinted 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 column with the heading SDTMIG Target. See 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 preprinted 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 header.",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 column with the heading SDTMIG Target.,(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 while the subject was fasted.,32
Findings,PC,PK Sample Collection over a Time Interval,N/A,14,PCCOND,PK Sampling 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.,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 preprinted 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, or Exercise.",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 column with the heading SDTMIG Target. 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 preprinted on the CRF.",PCSPEC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 preprinted 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 column with the heading SDTMIG Target. 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 the analyte test results are collected on the CRF, the test would be the analyte name. It is recommended that the test names be preprinted 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 header.",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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 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 whether or not a planned physical examination was performed.,Was the physical examination performed?,Physical Exam Performed,Char,O,"If physical examination was performed as planned then 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 then 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 category of the physical examination?,[PE Category]; NULL,Char,O,"Record the physical examination category, if not preprinted on the CRF.",PECAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. The CRF can capture the different types of Physical Exams using PECAT (e.g., GENERAL, OPHTHAMOLOGIC, NEUROLOGICAL). This may be preprinted on the CRF. If PECAT is not collected (e.g., it is self-evident from the protocol design), it could be populated during the SDTM-based dataset creation process.",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,"Record the physical examination subcategory, if not preprinted on the CRF.",PESCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. The CRF can capture the different subtypes of PE categories using PESCAT. This may be preprinted on the CRF. If PESCAT is not collected (e.g. it is self-evident from the protocol design), it could be populated during the SDTM-based dataset creation process. 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) and 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 preprinted 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.",PESPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.",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 column with the heading SDTMIG Target. The SDTMIG variable PETESTCD may be determined from the value collected in PETEST.,N/A,N/A,"Sponsor should pre-print all body systems to be examined on the CRF. The use of a complete list of body systems eliminates the need for another, specify category as any abnormalities identified should fall under 1 of the prespecified categories. If the form is laid out as a grid, then words such as ""Body System"" can be included as the column header.",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 the SDTM-based datasets are created, 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 or 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 \n,An indication 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? If Yes select Yes, otherwise, select 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 column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be preprinted 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 was 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,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 prespecified 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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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, which means 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 RPDTC in ISO 8601 format.",N/A,N/A,"The date the reproductive system findings were collected can be determined from the Visit Data 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 preprinted on the CRF.",RPCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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
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 preprinted on the CRF.",RPSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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. 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 whether or not 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 v3.2 Section 4.1.5.1.2.",(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 of 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 column with the heading SDTMIG Target.,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 or not there are any reproductive system findings 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 aCRF is annotated to indicate 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 preprinted 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.",RPSPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.",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,"Record the name of the reproductive system finding if not preprinted 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 column with the heading SDTMIG Target. 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 the test names be preprinted 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 header.",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 reproductive system finding.,RPORRES,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 or select the original unit in which these data were collected, if not preprinted on CRF.",RPORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text.",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 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,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 DD-MON-YYYY format.,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 column with the heading SDTMIG Target.,N/A,(CCCAT);(ONCRSCAT),"This is most commonly either a heading or a preprinted category value on the CRF, and 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 as the column header. There are separate codelists used for categorizations of 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 sub -category 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 column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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. 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 whether or not 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 v3.2 Section 4.1.5.1.2.",(NY),N/A,"A Not Done check box, which indicates the test was ""NOT DONE"". Typically, there would be one 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 column with the heading SDTMIG Target.,N/A,N/A,"The reason the 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,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 classifiaction] assessment?,Evaluator,Char,R/C,Indicate who performed the assessment.,RSEVAL,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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 of more evaluator are used in a study.,10
Findings,RS,N/A,N/A,11,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 column with the heading SDTMIG Target.,(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.",11
Findings,RS,N/A,N/A,12,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 Identifier.",RSLNKID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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.",12
Findings,RS,N/A,N/A,13,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 Identifier.",RSLNKGRP,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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.",13
Findings,RS,N/A,N/A,14,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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 header.",14
Findings,RS,N/A,N/A,15,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 column with the heading SDTMIG Target.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,15
Findings,RS,N/A,N/A,16,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 preprinted on CRF",RSORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text. Should be included if applicable and not available elsewhere.",16
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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 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 preprinted on the CRF.",SCCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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
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 preprinted on the CRF.",SCSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. 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 whether or not 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 v3.2 Section 4.1.5.1.2.",(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 preprinted 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.",SCSPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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.",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 characteristic(s) was collected?,Date,Char,R/C,Record date the subject characteristic(s) was 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) and 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 preprinted 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 column with the heading SDTMIG Target. 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 preprinted 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 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's characteristic?,(Result),Char,HR,Record the subject characteristic.,SCORRES,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 prepopulated 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 column with the heading SDTMIG Target.,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 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 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 preprinted on the CRF.",SCCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. This CDASH variable name is an example of what ""variable name"" 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 preprinted on the CRF.",SCSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. SCSCAT can only be used if there is an SCCAT and it must be a subcategorization of SCCAT. This CDASH variable name is an example of what ""variable name"" can be used in a denormalized data structure.",19
Findings,SC,N/A,Horizontal-Generic,8,[SCTESTCD]_SCPERF,SC Assessment Performed,An indication whether or not 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 v3.2 Section 4.1.5.1.2.",(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 CDASH variable name is an example of what ""variable name"" 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. Sponsor may insert additional instructions to ensure each record has a unique group identifier.,SCGRPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 DD-MON-YYYY format.,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 preprinted on the CRF.",TUCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This is most commonly either a heading or a preprinted 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
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 sub -category for the [tumor/lesion] identification?,[Tumor/Lesion] Identification Subcategory; or NULL,Char,O,"Record the Tumor Identification subcategory, if not preprinted on the CRF.",N/A,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This is most commonly preprinted 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. TUSCAT can only be used if there is an TUCAT and it must be a subcategorization of TUCAT.,7
Findings,TU,N/A,N/A,8,TUYN,Any Tumors/ Lesions Identification,An indication whether or not 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 if the there are [tumors/lesions] 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?; or 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 column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a preprinted, or collected. Sponsors may collect the data using a subset list of CT 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,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?,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 v3.2 Section 8.2 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 SDTM variable listed in the column with the heading "SDTM Target".,(METHOD),N/A,"The method used to identify the tumor/lesions. Sponsors may collect the method using a codelist which includes the most commonly known/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 column with the heading SDTMIG Target.,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. A sponsor may also decide to use the CDASH variable TUPRNO as an identifier for the 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 or Lesion Identification Test Name],Char,HR,"Record the name of the TU test, if not preprinted 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 column with the heading SDTMIG Target. The SDTMIG variable TUTESTCD may be determined from the value collected in TUTEST. The SDTMIG variables TUTESTCD and TUTEST are required in the 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 the test names be preprinted 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 header.",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 Tumor Identification classification. This may be preprinted 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 column with the heading SDTMIG Target.,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 CDASH variable name is an example of what ""variable name"" 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 column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 detail description of the location of the identified tumor/lesion.,What [were/are] additional details on the exact location of the tumor so that it can be distinguished from other tumors 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 column with the heading SDTMIG Target.,N/A,N/A,Recommended to collect on the CRF if vendor names 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 DD-MON-YYYY format.,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, sponsor may insert instructions to ensure each record has the appropriate identifier.",TRLNKGRP,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 preprinted on the CRF.",TRCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading or a preprinted 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.",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 preprinted on the CRF.",TRSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,Sponsor-defined controlled terminology. This would most commonly be preprinted 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 an TRCAT and it must be a subcategorization of TRCAT.,8
Findings,TR,N/A,N/A,9,TRSTAT,Tumor/Lesion Result Completion Status,The variable 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 column with the heading SDTMIG Target.,(ND),N/A,"A Not Done check box, which indicates the test was NOT DONE. Typically, there would be one 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 column with the heading SDTMIG Target.,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? OR 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 column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a preprinted 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 column with the heading SDTMIG Target.,(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?,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 column with the heading SDTMIG Target.,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 /lesion. \n Note: This variable may be collected using one CDASH variable name (e.g., TULNKID) and populated into TRLNKID when the submisson datasets are created.",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 preprinted 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 column with the heading SDTMIG Target. The SDTMIG variable TRTESTCD may be determined from the value collected in TRTEST. The SDTMIG variables TRTESTCD and TRTEST are required in the 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 preprinted 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 header.",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 column with the heading SDTMIG Target. 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 qualitatve 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 preprinted on CRF.",TRORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,Usually the unit of the test is preprinted 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 column with the heading SDTMIG Target.,N/A,N/A,Recommended to collect on the CRF if vendor names 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",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 column with the heading SDTMIG Target.,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.",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 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 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.",5
Findings,VS,N/A,Horizontal-Generic,6,[VSTESTCD]_VSPERF,Vital Signs Performed,"An indication whether or not 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 v3.2 Section 4.1.5.1.2.",(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 and 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 preprinted on the CRF.",VSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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.",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 preprinted on the CRF.",VSSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. 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. Sponsor may insert additional instructions to ensure each record has a unique group identifier.,VSGRPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,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 point 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 preprinted on the CRF.",VSTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. See SDTMIG for additional 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 preprinted 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 header. The planned time point of each measurement can also be collected using a CDASH variable [VSTESTCD]_VSTPT.",12
Findings,VS,N/A,Horizontal-Generic,13,[VSTESTCD]_VSSTAT,Vital Signs Completion Status,The variable 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 column with the heading SDTMIG Target.,(ND),N/A,"A single ""Not Done"" can be collected once for all the 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 column with the heading SDTMIG Target. 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 CDASH variable name is an example of what ""variable name"" 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 preprinted on CRF.",VSORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(VSRESU),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]_VSSTAT. Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text.",15
Findings,VS,N/A,Horizontal-Generic,16,[VSTESTCD]_VSCLSIG,Vital Signs Clinical Significance,An indication whether the vital signs results were clinically significant.,Was the [VSTEST] result clinically significant?,[VSTEST] Clinically Significant,Char,O,Record whether 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 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 column with the heading SDTMIG Target.,(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 measurement.,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 preprinted on CRF.",VSLOC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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 column with the heading SDTMIG Target.,N/A,N/A,"While 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.",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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",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 column with the heading SDTMIG Target.,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 prepopulated 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 column with the heading SDTMIG Target.,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.",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 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 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 whether or not 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 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 v3.2 Section 4.1.5.1.2.",(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) and 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 preprinted 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.",VSSPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.",28
Findings,VS,N/A,N/A,10,VSTPT,Vital Signs Planned Time Point Name,A text description of planned time point 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 preprinted on the CRF.",VSTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. See SDTMIG for additional 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 preprinted 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 header.",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 preprinted on the CRF.",VSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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,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 preprinted on the CRF.",VSSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. 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 non-standard variables in SDTM domains.,N/A,N/A,"The repetition number of the test/measurement within the time point may be preprinted 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 preprinted 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 column with the heading SDTMIG Target. 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 the test names be preprinted 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 header.",33
Findings,VS,N/A,N/A,15,VSSTAT,Vital Signs Completion Status,The variable 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 column with the heading SDTMIG Target.,(ND),N/A,"A Not Done check box, which indicates the test was NOT DONE. Typically, there would be one check box for each measurement. This field can be useful on individual vital signs 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 column with the heading SDTMIG Target.,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 preprinted on CRF.",VSORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(VSRESU),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter 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 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 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 measurement.,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 preprinted on CRF.",VSLOC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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 column with the heading SDTMIG Target.,(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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
Findings,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",2
Findings,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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",3
Findings,FA,N/A,N/A,4,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 column with the heading SDTMIG Target.,N/A,N/A,"The FAOBJ will usually be preprinted or hidden, and not solicited as an actual question. These FA domains are usually created by the sponsor.",4
Findings,FA,N/A,N/A,5,FAYN,Findings About Collected,An indication whether or not any 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 aCRF is annotated to indicate that this field is NOT SUBMITTED.,(NY),N/A,"This is a field that can be used in any CRF to indicate whether or not there is data to record. Used primarily as a data cleaning field. This 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, observations were done.",5
Findings,FA,N/A,N/A,6,FAPERF,Findings About Performed,"An indication of whether or not 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 v3.2 Section 4.1.5.1.2.",(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 FASTAT variable in SDTM as ""NOT DONE"".",6
Findings,FA,N/A,N/A,7,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 preprinted 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 SDTM variable listed in the column with the heading SDTMIG Target. 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 preprinted 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 header.",7
Findings,FA,N/A,N/A,8,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 preprinted on the CRF.",FATSTDTL,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"It is recommended that the test detail name be preprinted on the CRF. If the form is laid out as a grid, then words such as ""Test,"" ""Test Name"" can be included as the column header.",8
Findings,FA,N/A,N/A,9,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 preprinted on the CRF.",FACAT,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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.",9
Findings,FA,N/A,N/A,10,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 preprinted on the CRF.",FASCAT,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. FASCAT can only be used if there is a FACAT and it must be a subcategorization of FACAT.",10
Findings,FA,N/A,N/A,11,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 Findings About Test,FAPOS,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,(POSITION),N/A,N/A,11
Findings,FA,N/A,N/A,12,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 SDTM variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"In most cases, the Question Text and Item Prompt for the FAORRES are specific to the FATEST. The value of FATEST is most useful as the PROMPT on the field in which the RESULT for that test is collected. If the form is laid out as a grid, then words such as ""Result"" can be included as the column header.",12
Findings,FA,N/A,N/A,13,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,"Record or select the unit of measure associated with the test, if not preprinted on the CRF.",FAORRESU,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"The Question Text and Item Prompt for the FAORRESU may be specific to the FATEST. Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text (e.g., IN, LB, kg/L).",13
Findings,FA,N/A,N/A,14,FAORNRLO,FA Normal Range Lower Limit- Orig Unit,The lower end of normal range or reference range for continuous results stored in --ORRES.,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 Findings About test.,FAORNRLO,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,N/A,N/A,--ORNRLO should be populated only for continuous findings. The SDTM variable --STNRC should be populated only for non-continuous 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.,14
Findings,FA,N/A,N/A,15,FAORNRHI,FA Normal Range Upper Limit- Orig Unit,The upper end of normal range or reference range for continuous results stored in --ORRES.,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 Findings About test.,FAORNRHI,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,N/A,N/A,--ORNRHI should be populated only for continuous findings. The SDTM variable --STNRC should be populated only for non-continuous 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.,15
Findings,FA,N/A,N/A,16,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 SDTM variable listed in the column with the heading SDTMIG Target.,(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.",16
Findings,FA,N/A,N/A,17,FASTAT,Findings About Completion Status,The variable 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 SDTM variable listed in the column with the heading SDTMIG Target. 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 check box 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.,17
Findings,FA,N/A,N/A,18,FAREASND,Findings About Reason Not Performed,An explanation of why the 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 a Finding About test was not collected.,FAREASND,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,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.",18
Findings,FA,N/A,N/A,19,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 SDTM variable listed in the column with the heading SDTMIG Target.,(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.",19
Findings,FA,N/A,N/A,20,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 condition of specimen.,FASPCCND,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,(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.",20
Findings,FA,N/A,N/A,21,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 measurement was performed, if not preprinted on CRF.",FALOC,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted when the sponsor needs to identify the specific anatomical location. Example: 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.",21
Findings,FA,N/A,N/A,22,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 SDTM variable listed in the column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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.,22
Findings,FA,N/A,N/A,23,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 SDTM variable listed in the column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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.,23
Findings,FA,N/A,N/A,24,FAPORTOT,FA Location Portion or Totality,"Qualifier for anatomical location further detailing the distribution, which means 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 of the Findings About.,FAPORTOT,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,(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.,24
Findings,FA,N/A,N/A,25,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 to measure Findings About test.,FAMETHOD,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,(METHOD),N/A,N/A,25
Findings,FA,N/A,N/A,26,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 to measure Findings About test.,FALEAD,Maps directly to the SDTM variable listed in the column with the heading SDTMIG Target.,N/A,N/A,N/A,26
Findings,FA,N/A,N/A,27,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 SDTM variable listed in the column with the heading SDTMIG Target.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,27
Findings,FA,N/A,N/A,28,FAEVAL,Findings About Evaluator,The role of the person who provided 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 SDTM variable listed in the column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a preprinted, or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",28
Findings,FA,N/A,N/A,29,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 SDTM variable listed in the column with the heading SDTMIG Target.,(MEDEVAL),N/A,This variable is used in conjunction with FAEVAL to provide an additional level of detail.,29
Findings,FA,N/A,N/A,30,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 [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,30
Findings,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 column with the heading SDTMIG Target.,N/A,N/A,"While 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
Findings,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 column with the heading SDTMIG Target.,N/A,N/A,"Paper: This is typically preprinted 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 preprinted on the CRFs that are shipped to each site. EDC: This should be prepopulated.",2
Findings,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 column with the heading SDTMIG Target.,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 SDTM Implementation Guide.",3
Findings,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 column with the heading SDTMIG Target.,N/A,N/A,"The name of the visit is typically preprinted 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 these cases, the appropriate visit numbers and visit names, may need to be populated when the SDTM submission datasets are created.",4
Findings,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 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 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,SR,N/A,N/A,6,SRPERF,Skin Response Test Performed,"An indication whether or not 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 as 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 v3.2 Section 4.1.5.1.2.",(NY),N/A,General prompt question to be used as a data management tool to verify that missing results are confirmed missing.,6
Findings,SR,N/A,N/A,7,SRREASND,Skin Response Reason Not Done,An explanation of why the 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 column with the heading SDTMIG Target.,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,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 preprinted on the CRF.",SRCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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.",8
Findings,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 preprinted on the CRF.",SRSCAT,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,N/A,N/A,"Sponsor-defined controlled terminology. This would most commonly be either a heading, or a preprinted 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. SRSCAT can only be used if there is an SRCAT and it must be a subcategorization of SRCAT.",9
Findings,SR,N/A,N/A,10,SRSPID,Skin Response Sponsor-Defined Identifier,"A sponsor-defined identifier. In CDASH, This is typically used for preprinted 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.",SRSPID,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. 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.",10
Findings,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 column with the heading SDTMIG Target.,N/A,N/A,N/A,11
Findings,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 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,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 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,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 measurement was performed, if not preprinted on CRF.",SRLOC,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(LOC),N/A,"Collected or preprinted 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,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 column with the heading SDTMIG Target.,(LAT),N/A,May be preprinted 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,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 preprinted 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 column with the heading SDTMIG Target. SRTESTCD may be determined from the value collected in SRTEST. The SDTMIG variables SRTESTCD and SRTEST are required in the 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 preprinted 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 header.",16
Findings,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 preprinted on the CRF.",SRTPT,"Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target. See 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 point are needed to differentiate multiple sequential assessments. It is recommended that time points should be preprinted 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 header.",17
Findings,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 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) and in such cases a separate measurement date field is not required.,18
Findings,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 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) and in such cases a separate measurement date field is not required.,19
Findings,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 column with the heading SDTMIG Target.,(DIR),N/A,May be preprinted 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,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 column with the heading SDTMIG Target.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a preprinted or collected. Sponsors may collect the data using a subset list of controlled terminology on the CRF.",21
Findings,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 column with the heading SDTMIG Target.,(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,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 column with the heading SDTMIG Target.,N/A,N/A,N/A,23
Findings,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 measure associated with the test, if not preprinted on the CRF.",SRORRESU,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(UNIT),N/A,"Should be preprinted on the CRF with the associated test when possible, rather than collected in a field that requires the site to enter text.",24
Findings,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 where the test results were categorized within the respective reference range (e.g. HIGH, LOW, ABNORMAL).",SRNRIND,Maps directly to the SDTMIG variable listed in the column with the heading SDTMIG Target.,(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,SR,N/A,N/A,26,SRCLSIG,Skin Response Clinical Significance,An indication 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