TIG v1.0 CDASH Metadata Staging

	Product Type	Name	Description	Label	Registration Status	Effective Date	Source	Version	SDTMIG Version	Prior Version	Parent Model
	cdashig	CDASH for TIG v1.0	Implementation of the CDASH Model for the TIG v1.0 Product Impact on Individual Health use case.	TIG CDASH	Draft	Oct 17, 2023	CDISC Tobacco Implementation Guide Team	tig-1-0	tig-1-0		1-2
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Ordinal	Name	Label	Description
1	Interventions	Interventions	This SDTM class captures investigational, therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine). (Source: CDISC Controlled Terminology, GNRLOBSC, C103374, 2024-03-29)
2	Events	Events	This SDTM class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). (Source: CDISC Controlled Terminology, GNRLOBSC, C103372, 2024-03-29)
3	Findings	Findings	This SDTM class captures the observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, ECG testing, and questions listed on questionnaires. (Source: CDISC Controlled Terminology, GNRLOBSC, C103373, 2024-03-29)
4	Findings About	Findings About	This SDTM class is a specialization of the findings general observation class. It is intended, as its name implies, to be used when collected data represent findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. (Source: CDISC Controlled Terminology, GNRLOBSC, C135396, 2024-03-29)
5	Special-Purpose	Special-Purpose	This SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE and SV. (Source: CDISC Controlled Terminology, GNRLOBSC, C103377, 2024-03-29)
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Ordinal	Name	Label	Class
1	AE	An events domain used for data describing unintended signs, symptoms, or diseases temporally associated with the defined study period.	Events
2	DS	An events domain that contains information encompassing and representing data related to subject disposition.	Events
3	DV	An events domain that contains protocol violations and deviations during the course of the study.	Events
4	EM	An events domain for representing tobacco product device events, issues, and malfunctions that may occur during its use or testing. Since events may or may not be associated with a subject, USUBJID is a permissible variable.	Events
5	MH	An events domain that contains data that includes the subject's prior medical history at the start of the trial.	Events
6	DA	A findings domain that contains the accountability of study product, such as information on the receipt, dispensing, return, and packaging.	Findings
7	EG	A findings domain that contains ECG data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected or derived.	Findings
8	IE	A findings domain that contains those criteria that cause the subject to be in violation of the inclusion/exclusion criteria.	Findings
9	LB	A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains.	Findings
10	PC	A findings domain that contains concentrations of drugs or metabolites in fluids or tissues as a function of time.	Findings
11	RE	A findings domain that contains physiological and morphological findings related to the respiratory system, including the organs that are involved in breathing such as the nose, throat, larynx, trachea, bronchi and lungs.	Findings
12	SC	A findings domain that contains subject-related data not collected in other domains.	Findings
13	VS	A findings domain that contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight.	Findings
14	FA	A findings domain that contains the findings about an event or intervention that cannot be represented within an events or interventions domain record or as a supplemental qualifier.	Findings About Events or Interventions
15	CM	An interventions domain that contains concomitant and prior medications used by the subject, such as those given on an as needed basis or condition-appropriate medications.	Interventions
16	EC	An interventions domain that contains information about protocol-specified study product administrations, as collected.	Interventions
17	EX	An interventions domain that contains the details of a subject's exposure to protocol-specified study products. A study product may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject.	Interventions
18	SU	An interventions domain that contains information on the use of recreational products such as caffeine, alcohol, tobacco/nicotine, and other recreational drugs that may be of interest to the study.	Interventions
19	DM	A special-purpose domain that includes a set of essential standard variables that describe each subject in study. One record will exist for each subject.	Special-Purpose
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Ordinal	Name	Label	Class	Is Implementation Option?	Domain
1	Horizontal-Generic	Horizontal-Generic	Findings	no	DA
2	Birth date collection using a single date field	Birth date collection using a single date field	Special-Purpose	no	DM
3	Birth date collection using three date fields	Birth date collection using three date fields	Special-Purpose	no	DM
4	PROTOCOL MILESTONE/OTHER EVENT	PROTOCOL MILESTONE/OTHER EVENT	Events	no	DS
5	STUDY PARTICIPATION DISPOSITION EVENT	STUDY PARTICIPATION DISPOSITION EVENT	Events	no	DS
6	Central Reading	Central Reading	Findings	no	EG
7	Central Reading with Investigator Assessment	Central Reading with Investigator Assessment	Findings	no	EG
8	Local Reading	Local Reading	Findings	no	EG
9	Central Processing	Central Processing	Findings	no	LB
10	Central Processing with CS	Central Processing with CS	Findings	no	LB
11	Local Processing	Local Processing	Findings	no	LB
12	PK Sample Collection at Fixed Time Points	PK Sample Collection at Fixed Time Points	Findings	no	PC
13	PK Sample Collection over a Time Interval	PK Sample Collection over a Time Interval	Findings	no	PC
14	Horizontal-Generic	Horizontal-Generic	Findings	no	SC
15	Horizontal-Generic	Horizontal-Generic	Findings	no	VS
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Source Page	TATOBA:CDASH specifications
Valid Tables	19
Destination	Library
Options	Page diving Table walking Sequencing Exclude symbolic columns Exclude symbolic values Show line breaks
Output Format	CSV
Observation Class,Domain,Data Collection Scenario,Implementation Options,Order Number,Collection Variable,Collection Variable Label,DRAFT Collection Definition,Question Text,Prompt,Data Type,Collection Core,Case Report Form Completion Instructions,Tabulation Target,Mapping Instructions,Controlled Terminology Codelist Name,Subset Controlled Terminology/CDASH Codelist Name,Implementation Notes,Seq. for Order
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included into the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed for the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,AE,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected for all domains. However, this collection variable is populated only in the tabulation DM dataset.",3
Events,AE,N/A,N/A,4,AEYN,Any Adverse Experience,An indication of whether any AEs were experienced during the study.,Were any adverse events experienced?,Any Adverse Experiences,Char,O,"Indicate if the subject had any adverse experiences. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an tabulation variable.,(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 Experience,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the adverse experience?,[Adverse Experience Category]; NULL,Char,O,"Record the adverse experience category, if not pre-printed on the CRF.",AECAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading.",5
Events,AE,N/A,N/A,6,AESCAT,Subcategory for Adverse Experience,A sub-division of the AECAT values based on user-defined characteristics.,What is the subcategory of the adverse experience?,[Adverse Experience Subcategory]; NULL,Char,O,"Record the adverse experience subcategory, if not pre-printed on the CRF.",AESCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. AESCAT can only be used if there is an AECAT and it must be a subcategorization of AECAT.,6
Events,AE,N/A,N/A,7,AESPID,AE Applicant-Defined Identifier,"A applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field.",[Applicant-defined question],[Applicant defined],Char,O,"If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.",AESPID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is an applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medications, procedures and/or medical history records with AEs. If CMAENO or PRAENO is used, this is the identifier to which CMAENO or PRAENO refers. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the applicant's data collection system.",7
Events,AE,N/A,N/A,8,AETERM,Reported Term for the Adverse Experience,The reported or pre-specified name of the adverse experience.,What is the adverse experience term?,Adverse Experience,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Can be represented either as an open-entry field to capture verbatim terms reported by subjects or pre-printed, in the situation where solicited AEs of interest are captured. In most cases, the verbatim term (i.e., investigator-reported term) will be coded to a standard medical dictionary (e.g., MedDRA, WHO ART) after the data have been collected on the CRF.",8
Events,AE,N/A,N/A,9,AEOCCUR,Adverse Experience Occurrence,An indication of whether a pre-specified adverse experience or a group of adverse experiences occurred when information about the occurrence of a specific experience is solicited.,Did the subject have [pre-specified adverse experience/group of adverse experiences]?,[Specific Adverse Experience ],Char,O,"Indicate if [specific adverse experience] has occurred/is occurring, by checking Yes or No.",FA.FAORRES,"This does not map directly to an tabulation variable. Because the tabaulation AE domain is intended to hold only adverse experiences that actually happen, all values collected in AEOCCUR for pre-specified AEs should be represented in a Findings About Adverse Experiences 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 collection variable AEOCCUR is used to indicate the occurrence of pre-specified adverse experiences (e.g., ""Did the subject have high blood pressure?""). AEOCCUR should not be used for spontaneously reported adverse experiences. The site should be able to indicate that the response was not asked or answered.",9
Events,AE,N/A,N/A,10,AEPRESP,Pre-specified Adverse Experience,An indication that a specific experience or group of experiences are pre-specified on a CRF.,N/A,N/A,Char,O,N/A,AEPRESP,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"A hidden field on a CRF defaulted to ""Y"", or added during tabulation dataset creation, when the AE is pre-specified. Null for spontaneously reported experiences. If a study collects both pre-specified and free-text adverse experiences, the value of AEPRESP should be ""Y"" for all pre-specified experiences and null for experiences reported as free-text. AEPRESP is a permissible field and may be omitted from the tabulation dataset if all experiences were collected as free text.",10
Events,AE,N/A,N/A,11,AESTDAT,Adverse Experience Start Date,"The start date of the adverse experience, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What is the adverse experience start date?,Start Date,Char,HR,Record the start date of the adverse experience using this format (DD-MON-YYYY).,AESTDTC,"This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation 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 Experience,"The start time of the adverse experience, represented in an unambiguous time format (e.g., hh:mm:ss).",What is the adverse experience start time?,Start Time,Char,R/C,Record the start time (as complete as possible) of the adverse experience.,AESTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation 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.,12
Events,AE,N/A,N/A,13,AELOC,AE Location of Experience,A description of the anatomical location relevant for the adverse experience.,What is the anatomical location of the adverse experience?,Anatomical Location,Char,O,Indicate the anatomical location of the adverse experience.,AELOC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LOC),N/A,"Collected or pre-printed when the applicant needs to identify the specific anatomical location. applicants 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 Experience Laterality,"Qualifier for anatomical location, further detailing the side of the body relevant for the experience.",What is the side of the anatomical location of the adverse experience?,Side,Char,O,Record the side of the anatomical location of the adverse experience.,AELAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LAT),N/A,May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. applicants may collect the data using a subset list of controlled terminology on the CRF.,14
Events,AE,N/A,N/A,15,AEDIR,Adverse Experience 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 experience?,Directionality,Char,O,Record the directionality of the anatomical location of the adverse experience.,AEDIR,Maps directly to the tabulation variable listed in the Tabulation Target column.,(DIR),N/A,May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. applicants 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 experience?,Portion or Totality,Char,O,Indicate the portion or totality anatomical location of the adverse experience.,AEPORTOT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(PORTOT),N/A,Collected when the applicant needs to identify the specific portionality for the anatomical locations. applicants 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 Experience,Indication that an adverse experience is ongoing when no end date is provided.,Is the adverse experience 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 experience has not resolved at the time of data collection; leave the End Date blank.,AEENRTPT; AEENRF,"This does not map directly to an tabulation variable. May be used to populate a value into a tabulation 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 Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the tabulation variable AEENRF should be populated. When AEONGO is compared to another time point, the tabulation variables AEENRTPT and AEENTPT should be used. Note: AEENRTPT must refer to a time-point anchor described in AEENTPT.",(NY),N/A,"Completed to indicate that the AE has not resolved at the time of data collection, when no end date is collected. In some cases the ongoing status may be determined from AE Outcome. The purpose of collecting this field is to help with data cleaning and monitoring; this field provides further confirmation that End Date was deliberately left blank. Often used as a tick/checkbox.",17
Events,AE,N/A,N/A,18,AEENDAT,Adverse Experience End Date,"The date when the adverse experience resolved/ended, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the adverse experience end date?,End Date,Char,R/C,"Record the date that the adverse experience. resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.",AEENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable AEENDTC in ISO 8601 format.",N/A,N/A,"The definition of resolved is applicant-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 Experience,"The time when the adverse experience ended/resolved, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the adverse experience end time?,End Time,Char,R/C,Record the time (as complete as possible) that the adverse experience resolved.,AEENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation 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.,19
Events,AE,N/A,N/A,20,AESEV,AE Severity/Intensity,The severity or intensity of the experience.,What is the severity of the adverse experience?,Severity,Char,R/C,The reporting physician/healthcare professional will assess the severity of the experience using the applicant-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported adverse experience to similar type experiences observed in clinical practice. Severity is not equivalent to seriousness.,AESEV,Maps directly to the tabulation variable listed in the Tabulation Target column.,(AESEV),N/A,Either AESEV or AETOXGR must appear on the CRF. Some studies may mandate the collection of both.,20
Events,AE,N/A,N/A,21,AETOXGR,AE Standard Toxicity Grade,"The grade of the severity of the experience using a standard ""toxicity"" scale (e.g., NCI CTCAE).",What is the [NCI CTCAE/Name of scale (toxicity) grade] of the adverse experience?,[NCI CTCAE/ Name of the scale] (Toxicity) Grade,Char,R/C,The reporting physician/healthcare professional will assess the severity of the adverse experience using the specified grades scale.,AETOXGR,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external codelist attributes.,N/A,N/A,Either AESEV or AETOXGR must appear on the CRF. Some studies may mandate the collection of both. Published toxicity-like scales can be used.,21
Events,AE,N/A,N/A,22,AESER,AE Serious Experience,"An indication of whether the adverse experience is determined to be ""serious,"" based on what is defined in the protocol.",Was the adverse experience serious?,Serious,Char,R/C,"Assess if the adverse experience should be classified as ""serious,"" based on the criteria defined in the protocol.",AESER,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"This field is related to the individual SAE-type fields, which may or may not be collected on the CRF. Either AESER or all the SAE-type fields must be present on the CRF. Applicants should consult with regulatory agencies regarding the collection of this data.",22
Events,AE,N/A,N/A,23,AESDTH,Results in Death,An indication the serious adverse experience resulted in death.,Did the adverse experience result in death?,Death,Char,R/C,Record whether the serious adverse experience resulted in death.,AESDTH,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. applicants may only collect the AESER field when collecting individual SAE types in a separate database. Applicants should consult with regulatory agencies regarding the collection of this data.",23
Events,AE,N/A,N/A,24,DTHDAT,Death Date,Date of death for any subject who died.,What [is/was] the subject's date of death?,Death Date,Char,O,Record the date of death.,DM.DTHDTC,"This field does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DTHDTC in ISO 8601 format.",N/A,N/A,"In the CDASH model, Death Date is a timing variable; it is not included as a timing variable in the SDTM. It may be collected on any CRF deemed appropriate by the applicant, but should only be collected once. The tabulation variable DTHDTC is mapped to the DM domain during the tabulation dataset creation process. The tabulation variable DM.DTHFLG is not a collection variable, but it is typically populated during the tabulation dataset creation process. Death Date may be mapped to other tabulation domains, as deemed appropriate by the applicant (e.g., DS).",24
Events,AE,N/A,N/A,25,AESLIFE,Is Life Threatening,An indication the serious adverse experience was life threatening.,Was the adverse experience life threatening?,Life Threatening,Char,R/C,Record whether the serious adverse experience is life threatening.,AESLIFE,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. applicants should consult with regulatory agencies regarding the collection of this data.",25
Events,AE,N/A,N/A,26,AESHOSP,Requires or Prolongs Hospitalization,An indication the serious adverse experience resulted in an initial or prolonged hospitalization.,Did the adverse experience result in initial or prolonged hospitalization for the subject?,Hospitalization (initial or prolonged),Char,R/C,Record whether the serious adverse experience resulted in an initial or prolonged hospitalization.,AESHOSP,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. applicants should consult with regulatory agencies regarding the collection of this data.",26
Events,AE,N/A,N/A,27,AESDISAB,Persist or Signif Disability/Incapacity,An indication the serious adverse experience was associated with a persistent or significant disability or incapacity.,Did the adverse experience result in disability or permanent damage?,Disability or Permanent Damage,Char,R/C,Record whether the serious adverse experience resulted in a persistent or significant disability or incapacity.,AESDISAB,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. applicants should consult with regulatory agencies regarding the collection of this data.",27
Events,AE,N/A,N/A,28,AESCONG,Congenital Anomaly or Birth Defect,An indication the serious adverse experience was associated with a congenital anomaly or birth defect.,Was the adverse experience associated with a congenital anomaly or birth defect?,Congenital Anomaly or Birth Defect,Char,R/C,Record whether the serious adverse experience was associated with congenital anomaly or birth defect.,AESCONG,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. applicants should consult with regulatory agencies regarding the collection of this data.",28
Events,AE,N/A,N/A,29,AESINTV,Needs Intervention to Prevent Impairment,"An indication an adverse experience 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 experience require intervention to prexperience permanent impairment or damage resulting from the use of a medical product?,Needs Intervention to Prevent Impairment,Char,O,Record whether the serious adverse experience 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 tabulation variable. applicants should see requirements for the reporting of adverse experiences involving medical devices.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate database. Applicants should consult with regulatory agencies regarding the collection of this data.",29
Events,AE,N/A,N/A,30,AESMIE,Other Medically Important Serious Experience,An indication additional categories for seriousness apply.,Was the adverse experience a medically important event not covered by other serious criteria?,Other Serious (Important Medical experiences),Char,R/C,"Record whether the serious adverse experience is an ""important medical exvent,"" which may be defined in the protocol or in the investigator brochure.",AESMIE,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate database. Applicants should consult with regulatory agencies regarding the collection of this data.",30
Events,AE,N/A,N/A,31,AESCAN,Involves Cancer,An indication the serious experience was associated with the development of cancer.,Was the adverse experience associated with the development of cancer?,Cancer,Char,O,Record whether the serious adverse experience was associated with development of cancer.,AESCAN,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate database. Applicants should consult with regulatory agencies regarding the collection of this data.",31
Events,AE,N/A,N/A,32,AESOD,Occurred with Overdose,An indication the serious experience occurred with an overdose.,Did the adverse experience occur with an overdose?,Overdose,Char,O,Record whether the serious adverse experience occurred with an overdose.,AESOD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Applicants should consult with regulatory agencies regarding the collection of this data.",32
Events,AE,N/A,N/A,33,AEREL,AE Causality,"An indication the study product had a causal effect on the adverse experience, as determined by the clinician/investigator.",Was this adverse experience related to study product?,Relationship to Study Product,Char,HR,"Indicate if the cause of the adverse experience is related to the study product and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions).",AEREL,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology is used to indicate the relationship between the AE and the study product. It is recommended that applicants check with the regulatory authority for population of this variable to ensure it meets expectations for submission. There is no industry-wide controlled terminology for relationship to product exposure. It is recommended that applicants establish terminology and apply it consistently.,33
Events,AE,N/A,N/A,34,AEACN,Action Taken with Study Product,A description of the action taken with study product as a result of the experience.,What action was taken with study product?,Action Taken with Study Product,Char,R/C,Record changes made to the study product resulting from the adverse experience.,AEACN,Maps directly to the tabulation variable listed in the Tabulation Target column.,(TPACN),N/A,"CDISC Controlled Terminology is used to indicate the action taken with the product in response to the AE. How to handle multiple actions taken is up to the applicant. 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.",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 experience.",What action was taken with a device used in the study?,Action Taken with Device,Char,O,Record actions taken resulting from the adverse experience that are related to a study or non-study device.,SUPPAE.QVAL,This does not map directly an tabulation variable. The applicant may represent this data in a SUPPAE dataset where SUPPAE.QNAM = "AEACNDEV" and SUPPAE.QLABEL = "Actions Taken with Device".,N/A,N/A,Applicant-defined controlled terminology for actions that are related to the device.,35
Events,AE,N/A,N/A,36,AEACNOTH,Other Action Taken,A description of other action taken as a result of the experience that is unrelated to dose adjustments of the study product.,What other action was taken?,Other Action Taken,Char,O,Record all other action(s) taken resulting from the adverse experience that are unrelated to study products given because of this AE.,AEACNOTH,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This is usually collected as a free-text field. If possible/desired, the applicant can create controlled terminology.",36
Events,AE,N/A,N/A,37,AEOUT,Outcome of Adverse Experience,A description of the outcome of an experience.,What is the outcome of this adverse experience?,Outcome,Char,R/C,Record the appropriate outcome of the experience in relation to the subject's status.,AEOUT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(OUT),N/A,"CDISC Controlled Terminology is used to indicate the outcome of the experience as it relates to the subject's status. The use of this field is the recommended way to describe whether and how the AE resolved. Because the outcome of an AE may be death, if this field is NOT used, be sure to provide another form, such as Disposition, with clear instructions to record deaths there.",37
Events,AE,N/A,N/A,38,AEDIS,AE Caused Study Discontinuation,An indication of whether the experience caused the subject to discontinue from the study.,Did the adverse experience cause the subject to be discontinued from the study?,Caused Study Discontinuation,Char,O,Record if the adverse experience caused the subject to discontinue from the study.,SUPPAE.QVAL,"This does not map directly an tabulation variable. May be used to create a RELREC tabulation dataset to link the AE to the DS dataset record. The applicant may also represent this data in a SUPPAE dataset where SUPPAE.QNAM = ""AEDIS"" and SUPPAE.QLABEL = ""Caused Study Discontinuation"", if appropriate.",(NY),N/A,"Because the Action Taken field was defined to only collect changes made in relation to the study product due to the AE, an additional field was created to identify the AE(s) that caused the subject to discontinue from the study. Some applicants 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 tabulation records, then RELREC can be used to identify that relationship.",38
Events,AE,N/A,N/A,39,AERLNSYN,AE Relationship to Non-Study Trtmnt or Prod,"An indication whether, in the investigator's opinion, the experience may have been due to a product other than study product.",Was this adverse experience due to product other than study product?,Related to Non-Study Product,Char,O,"Indicate if this adverse experience was due to product other than study product. If Yes, briefly describe this non-study product relationship.",N/A,Does not map to a tabulation variable.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the AERELNST collection field on the CRF was deliberately left blank.,39
Events,AE,N/A,N/A,40,AERELNST,AE Relationship to Non-Study Trtmnt or Prod,Description of the investigator's opinion as to whether the adverse experience may have been due to a product other than study product.,What is the relationship to non-study product?,Relationship to Non-Study Product,Char,O,Record the investigator's opinion as to whether the experience may have been due to a product other than study product.,AERELNST,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"May be reported as free text (e.g., ""MORE LIKELY RELATED TO ASPIRIN USE""). If possible/desired, applicants can create controlled terminology.",40
Events,AE,N/A,N/A,41,AESI,Adverse Experience of Special Interest,"An adverse experience of special interest (serious or non-serious) is one of scientific and medical concern specific to the applicant's product or program, for which ongoing monitoring and rapid communication by the investigator to the applicant can be appropriate. Such an experience might warrant further investigation in order to characterize and understand it. Depending on the nature of the experience, rapid communication by the study applicant to other parties (e.g., regulators) might also be warranted.",Is this experience of special interest?,Adverse Experience of Special Interest,Char,O,Record the investigator's opinion as to whether the experience is an adverse experience of special interest by the applicant.,N/A,Does not map to a tabulation variable.,(NY),N/A,"This collection field may be used just to trigger other CRF pages, or populate a value in AECAT or AESCAT. This information could be represented in a SUPPAE dataset where SUPPAE.QNAM = ""AESI"" and SUPPAE.QLABEL = ""Adverse experience of Special Interest.",41
Events,AE,N/A,N/A,42,AEPATT,Pattern of Adverse Experience,Used to indicate the pattern of the experience over time.,What is the adverse experience pattern?,Pattern,Char,O,"For each adverse experience, check the pattern of the AE. If a single experience, choose Single.",AEPATT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Used to report the pattern of the AE (e.g., ""INTERMITTENT"", ""CONTINUOUS"", ""SINGLE EVENT""). For crossover studies, 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 Product Given,An indication whether a concomitant or additional product given because of the occurrence of the experience.,Was a concomitant or additional product given due to this adverse experience?,Concomitant or Additional Product Given Due to This AE,Char,O,"Indicate if any non-study treatments or products were received because of this adverse experience. If Yes, medications should be recorded on the ConMed CRF and procedures recorded on the Procedures CRF.",AECONTRT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"If medication data are reported, the CMAENO variable (on the CM CRF) may be used to collect the associated AE Identifier in order to populate RELREC. If procedures are reported, the PRAENO variable (on the PR CRF) may be used to collect the associated AE Identifier in order to populate RELREC.",43
Events,AE,N/A,N/A,44,AEMODIFY,AE Modified Reported Term,"If the value for AETERM is modified to facilitate coding, then AEMODIFY will contain the modified text.",N/A,N/A,Char,R/C,N/A,AEMODIFY,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This is not a data collection field that would appear on the CRF. applicants 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 tabulation variable listed in the Tabulation Target column. The applicant 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. applicants will populate this through the coding process. Equivalent to the Preferred Term (PT) in MedDRA.,45
Events,AE,N/A,N/A,46,AELLT,AE Lowest Level Term,The dictionary-derived text description of the lowest level term.,N/A,N/A,Char,R/C,N/A,AELLT,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants 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. applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,46
Events,AE,N/A,N/A,47,AELLTCD,AE Lowest Level Term Code,The dictionary-derived code for the lowest level term.,N/A,N/A,Num,R/C,N/A,AELLTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants 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. applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,47
Events,AE,N/A,N/A,48,AEPTCD,AE Preferred Term Code,The dictionary-derived code for the preferred term.,N/A,N/A,Num,R/C,N/A,AEPTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants 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. applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,48
Events,AE,N/A,N/A,49,AEHLT,AE High Level Term,The dictionary-derived text description of the high level term for the primary system organ class (SOC).,N/A,N/A,Char,R/C,N/A,AEHLT,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants 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. applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,49
Events,AE,N/A,N/A,50,AEHLTCD,AE High Level Term Code,The dictionary-derived code for the high level term for the primary system organ class (SOC).,N/A,N/A,Num,R/C,N/A,AEHLTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants 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. applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,50
Events,AE,N/A,N/A,51,AEHLGT,AE High Level Group Term,The dictionary-derived text description of the high level group term for the primary system organ class (SOC).,N/A,N/A,Char,R/C,N/A,AEHLGT,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants 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. applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,51
Events,AE,N/A,N/A,52,AEHLGTCD,AE High Level Group Term Code,The dictionary-derived code for the high level group term for the primary system organ class (SOC).,N/A,N/A,Num,R/C,N/A,AEHLGTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants 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. applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,52
Events,AE,N/A,N/A,53,AESOC,AE Primary System Organ Class,The dictionary-derived text description of the primary system organ class (SOC).,N/A,N/A,Char,R/C,N/A,AESOC,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants 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. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as the AEBODSYS if the primary SOC was used for analysis.,53
Events,AE,N/A,N/A,54,AESOCCD,AE Primary System Organ Class Code,The dictionary-derived code for the primary system organ class (SOC).,N/A,N/A,Num,R/C,N/A,AESOCCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Applicants 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. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as AEBDSYCD if the primary SOC was used for analysis.,54
Events,AE,N/A,N/A,55,AEACNOYN,Any Other Actions Taken,An indication whether any other actions were taken in response to the adverse experience that were unrelated to study product changes or other treatments/products given because of this adverse experience.,Were any other actions taken in response to this adverse experience?,Any Other Action(s) Taken,Char,O,"Indicate whether any other action(s) were taken in response to the adverse experience that are unrelated to study product changes or other treatments/products given because of this experience. If Yes, briefly describe these actions.",N/A,Does not map to a tabulation variable.,(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,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,MH,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",3
Events,MH,N/A,N/A,4,MHYN,Any Medical History Event,An indication of whether there was any medical history to report.,Were any medical conditions or events reported?; Has the subject had any medical conditions or events?,Any Medical History,Char,O,"Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to a tabulation variable.,(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 applicant provides instructions to ensure the data is entered as intended.",MHCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology (e.g., CARDIAC, GENERAL). This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-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 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 applicant provides instructions to ensure the data is entered as intended.",MHSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Typically would be used when specific medical history (e.g., disease diagnosis) is captured, in addition to the general medical history. MHSCAT can only be used if there is an MHCAT, and it must be a subcategorization of MHCAT.",6
Events,MH,N/A,N/A,7,MHDAT,Medical History Collection Date,"The date on which the medical history was collected, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the medical history was collected?,Collection Date,Char,O,Record the date on which the medical history was collected using this format (DD-MON-YYYY).,MHDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 Applicant-Defined Identifier,"A applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field.",[Applicant-defined question],[Applicant defined],Char,O,"If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.",MHSPID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is a applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medications and/or procedure records with MH. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the applicant's data collection system. If CMMHNO or PRMHNO is used, this is the identifier to which CMMHNO or PRMHNO refers.",8
Events,MH,N/A,N/A,9,MHEVDTYP,Medical History Event Date Type,Specifies the aspect of the medical condition or event by which MHSTDTC and/or MHENDTC is defined.,What was the medical history event date type?,Medical History Event Date Type,Char,O,The instructions depend upon the format of the CRF. Applicants may print these values on the CRF or use them as defaulted or hidden text.,MHEVDTYP,Maps directly to the tabulation variable listed in the Tabulation Target column.,(MHEDTTYP),N/A,"The type of start/ and or end date (e.g.,, DIAGNOSIS, SYMPTOMS, RELAPSE, INFECTION). It is not related to the trial's condition. This date type cannot be a PRIMARY DIAGNOSIS, SECONDARY DIAGNOSIS because these terms do not define the date type.",9
Events,MH,N/A,N/A,10,MHTERM,Reported Term for the Medical History,The reported or pre-specified name of the medical condition or event.,What is the medical condition or event term?,Medical History Term,Char,HR,"Record all relevant medical conditions or events, as defined in the protocol. Record only 1 medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.",MHTERM,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicants should collect all relevant medical conditions or events, as defined in the protocol. It is a best practice for Applicants 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 tabulation PR domain. Applicants should provide instructions on how surgeries and procedures will be handled based on the protocol requirements. Information on specified surgeries or procedures should be collected in the PR domain.",10
Events,MH,N/A,N/A,11,MHOCCUR,Medical History Occurrence,An indication of whether a pre-specified medical condition/event or a group of medical conditions/events occurred when information about the occurrence of a specific event is solicited.,Did the subject have [prespecified medical condition/event/group of medical conditions]; Is the [prespecified medical occurring]?,[Medical condition/Event],Char,O,Indicate if [specific medical condition/event] has occurred/is occurring by checking Yes or No.,MHOCCUR,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,MHOCCUR is used to report the occurrence of specified medical conditions or events. MHOCCUR is not used if the medical conditions or events are collected on the CRF in a manner that requires spontaneously free-text response. The site should be able to indicate that the question was not asked or answered.,11
Events,MH,N/A,N/A,12,MHPRESP,Medical History Event Prespecified,"An indication that a specific event, or group of events, are pre-specified on a CRF.",N/A,N/A,Char,O,N/A,MHPRESP,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"A hidden field on a CRF defaulted to ""Y"", or added during the tabulation dataset creation when the medical condition or event is prespecified. Null for spontaneously reported events. If a study collects both pre-specified medical history and free-text events, the value of MHPRESP should be ""Y"" for all pre-specified events and null for medical conditions or events reported as free text. MHPRESP is a permissible and may be omitted from the tabulation dataset if all events were collected as free text.",12
Events,MH,N/A,N/A,13,MHPRIOR,Prior Medical History Event,An indication of whether the event occurred prior to study start.,Did the medical condition or event start prior to [MHSTTPT]?; Did the medical condition or event start prior to study start?,Prior to [MHSTTPT]; Prior to Study,Char,O,Check if the medical condition or event started [before the study].,MHSTRTPT; MHSTRF,"This does not map directly to a tabulation variable. May be used to populate a value into a tabulation relative timing variable such as MHSTRF or MHSTRTPT. When populating MHSTRF, or MHSTRTPT, if the value of the collection 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 tabulation variable MHSTRF should be populated. When MHPRIOR is compared to another time point, the tabulation variables MHSTRTPT and MHSTTPT should be used. Note: MHSTRTPT must refer to the time-point anchor described in MHSTTPT.",(NY),N/A,Applicants may collect this information rather than start dates.,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 a tabulation variable. May be used to populate a value into a tabulation 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 tabulation variable MHENRF should be populated. When MHONGO is compared to another time point, the tabulation 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.",14
Events,MH,N/A,N/A,15,MHCTRL,MH Disease or Symptom Under Control,Indication of whether the medical condition or event is under control at the time of data collection.,Is the medical condition or event under control?,Medical Condition Under Control,Char,O,Select the most appropriate response.,SUPPMH.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPMH dataset as the value of SUPPMH.QVAL where SUPPMH.QNAM ="MHCTRL" and SUPPMH.LABEL="Medical Condition Under Control".,(NY),N/A,"MHCTRL is not defined in the tabulation MH domain. If collected, it should be represented in the SUPPMH dataset. If MHCTRL is collected, the applicant 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 a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable MHSTDTC in ISO 8601 format.",N/A,N/A,"The applicant 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 a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable MHENDTC in ISO 8601 format.",N/A,N/A,"The applicant 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 tabulation variable listed in the Tabulation Target column.,(LOC),N/A,"Collected or pre-printed when the applicant 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]. Applicants 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 tabulation variable listed in the Tabulation Target column.,(LAT),N/A,May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants 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 tabulation variable listed in the Tabulation Target column.,(DIR),N/A,May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.,20
Events,MH,N/A,N/A,21,MHPORTOT,MH Event Location Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of).",What was the portion or totality of the anatomical location of the of the medical condition or event?,Portion or Totality,Char,O,Indicate the portion or totality anatomical location of the medical event.,MHPORTOT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(PORTOT),N/A,Collected when the applicant needs to identify the specific portionality for the anatomical locations. Applicants 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,This is not a data collection field that would appear on the CRF. Applicants 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,This is typically not a data collection field that will appear on the CRF. Applicants will populate this through the coding process. Equivalent to the Preferred Term (PT in MedDRA).,23
Events,MH,N/A,N/A,24,MHLLT,Medical History Event Lowest Level Term,The dictionary-derived text description of the lowest level term.,N/A,N/A,Char,O,N/A,MHLLT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,24
Events,MH,N/A,N/A,25,MHLLTCD,MH Event Lowest Level Term Code,The dictionary-derived code for the lowest level term.,N/A,N/A,Num,O,N/A,MHLLTCD,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,25
Events,MH,N/A,N/A,26,MHPTCD,MH Event Preferred Term Code,The dictionary-derived code for the preferred term.,N/A,N/A,Num,O,N/A,MHPTCD,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,26
Events,MH,N/A,N/A,27,MHHLT,Medical History Event High Level Term,The dictionary-derived text description of the high level term for the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,MHHLT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,27
Events,MH,N/A,N/A,28,MHHLTCD,MH Event High Level Term Code,The dictionary-derived code for the high level term for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,MHHLTCD,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,28
Events,MH,N/A,N/A,29,MHHLGT,MH Event High Level Group Term,The dictionary-derived text description of the high level group term for the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,MHHLGT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,29
Events,MH,N/A,N/A,30,MHHLGTCD,MH Event High Level Group Term Code,The dictionary-derived code for the high level group term for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,MHHLGTCD,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.,30
Events,MH,N/A,N/A,31,MHSOC,MH Event Primary System Organ Class,The dictionary-derived text description of the primary system organ class (SOC).,N/A,N/A,Char,O,N/A,MHSOC,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as MH BODSYS if the primary SOC was used for analysis.,31
Events,MH,N/A,N/A,32,MHSOCCD,MH Event Primary System Organ Class Code,The dictionary-derived code for the primary system organ class (SOC).,N/A,N/A,Num,O,N/A,MHSOCCD,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as MHBDSYCD if the primary SOC was used for analysis.,32
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,DV,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",3
Events,DV,N/A,N/A,4,DVCAT,Category for Protocol Deviation,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the protocol deviation?,[Protocol Deviation Category]; NULL,Char,O,"Record the deviation category, if not pre-printed on the CRF.",DVCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column header.",4
Events,DV,N/A,N/A,5,DVSCAT,Subcategory for Protocol Deviation,A sub-division of the DVCAT values based on user-defined characteristics.,What is the subcategory of the protocol deviation?,[Protocol Deviation Subcategory]; NULL,Char,O,"Record the deviation event subcategory, if not pre-printed on the CRF.",DVSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. DVSCAT can only be used if there is an DVCAT, and it must be a subcategorization of DVCAT.",5
Events,DV,N/A,N/A,6,DVYN,Any Protocol Deviation,An indication of whether there were any protocol deviations.,Were there any protocol deviations?,Any Deviations,Char,O,"Enter Yes if a protocol deviation occurred and No if none occurred. Ensure that any adverse event which triggers a protocol deviation (e.g., concomitant medication use, newly discovered medical history) is noted in the respective CRF.",N/A,Does not map to a tabulation variable.,(NY),N/A,The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.,6
Events,DV,N/A,N/A,7,DVDECOD,Protocol Deviation Coded Term,The applicant-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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"DVTERM and DVDECOD may have the same value. If the CRF is collecting protocol deviations using a codelist of responses, then DVDECOD should be used to store the codelist response. Appicants must use either DVDECOD or DVTERM on the CRF and, in some cases, both may be used. For example, if the CRF collects ""Specify, Other"" or similar additional free-text descriptions of codelist items, then DVTERM should be used to store the detailed descriptive text.",7
Events,DV,N/A,N/A,8,DVTERM,Protocol Deviation Term,The reported or pre-specified name of the protocol deviation.,What was the protocol deviation term?,(Specify) Protocol Deviation,Char,R/C,Record the appropriate code from the list of protocol deviation terms.,DVTERM,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"DVTERM and DVDECOD may have the same value. If the CRF is collecting protocol deviations using a free-text field, then DVTERM should be used to store the free-text response. Applicants may use either DVDECOD or DVTERM on the CRF, but a value in DVTERM is required in the tabulation datasets.",8
Events,DV,N/A,N/A,9,DVSTDAT,Deviation Start Date,"The start date of deviation, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the protocol deviation start date?,Start Date,Char,O,"Record the start date that the protocol deviation using this format (DD-MON-YYYY). This should be the start or occurrence of the protocol deviation, not the date it was discovered or reported.",DVSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DVSTDTC in ISO 8601 format.",N/A,N/A,This may be derived if not collected on a CRF.,9
Events,DV,N/A,N/A,10,DVSTTIM,Deviation Start Time,"The start time of the deviation, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the protocol deviation start time?,Start Time,Char,O,"If appropriate, record the start time (as complete as possible) of the protocol deviation in an unambiguous time format (e.g., hh:mm:ss). This should be the start or occurrence of the protocol deviation, not the time it was discovered or reported.",DVSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DVSTDTC in ISO 8601 format.",N/A,N/A,N/A,10
Events,DV,N/A,N/A,11,DVENDAT,Deviation End Date,"The end date of the deviation, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the protocol deviation end date?,End Date,Char,O,"Record the end date of the protocol deviation using this format (DD-MON-YYYY). This should be the date the protocol deviation stopped, not the date it was discovered or reported.",DVENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable DVENDTC in ISO 8601 format.",N/A,N/A,N/A,11
Events,DV,N/A,N/A,12,DVENTIM,Deviation End Time,"The end time of the deviation, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the protocol deviation end time?,End Time,Char,O,"If appropriate, record the end time (as complete as possible) of the protocol deviation in an unambiguous time format (e.g., hh:mm:ss). This should be the time the protocol deviation stopped, not the time it was discovered or reported.",DVENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable DVENDTC in ISO 8601 format.",N/A,N/A,N/A,12
Events,DV,N/A,N/A,13,DVSPID,DV Applicant-Defined Identifier,"An applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field.",[Applicant-defined question],[Applicant defined],Char,O,"If collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier.",DVSPID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is an applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the applicant's data collection system.",13
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",1
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be prepopulated.",2
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",3
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,4,DSCAT,Category for Disposition Event,"A categorization of the disposition events, which is used to distinguish between disposition events, protocol milestones, and other events.",What was the category of the disposition?,[Disposition Category],Char,HR,"If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.",DSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(DSCAT),N/A,"This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. In this implementation scenario, DSCAT=""PROTOCOL MILESTONE"" or ""OTHER EVENT"".",4
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,5,DSSCAT,Subcategory for Disposition Event,A sub-division of the DSCAT values based on user-defined characteristics.,What was the subcategory of the disposition?,[Disposition Subcategory]; NULL,Char,O,"If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.",DSSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. DSSCAT can only be used if there is an DSCAT and it must be a subcategorization of the Protocol Milestone or Other Event.,5
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,6,EPOCH,Epoch,"Trial Epoch (e.g., 'SCREENING', 'RUN-IN') for which subject disposition is being collected.",What is the trial period for this disposition event?,Trial Period,Char,R/C,"Check the [epoch, or insert more appropriate wording] for which disposition event is being recorded.",EPOCH,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EPOCH),N/A,"If protocol milestones or other events are collected more than once in the study, EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as part of the title of the page; however, some companies have a standard CRF module that includes a pick-list of epochs.",6
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,7,DSDECOD,Standardized Disposition Term,The standardized terminology of the disposition term.,[Applicant-defined],[Applicant-defined],Char,R/C,"If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.",DSDECOD,Maps directly to the tabulation variable listed in the Tabulation Target column. Both DSDECOD and DSTERM must be populated in the tabulation dataset.,(PROTMLST) \n (OTHEVENT),N/A,"Where DSCAT = ""PROTOCOL MILESTONE"", DSTERM contains the verbatim (as collected) and/or standardized text; DSDECOD uses the extensible controlled terminology codelist (PROTMLST). Where DSCAT=""OTHER EVENT"", DSDECOD uses the extensible controlled terminology codelist (OTHEVENT).",7
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,8,DSTERM,Reported Term for the Disposition Event,The verbatim or pre-specified name of the disposition term.,[Applicant-defined],[Applicant-defined],Char,R/C,"If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. \n \n \n \n \n",DSTERM,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variables DSDECOD and DSTERM must be populated in the tabulation dataset.,N/A,N/A,"When defining protocol milestones or other events, applicants may populate DSTERM and DSDECOD with the same value (e.g., INFORMED CONSENT OBTAINED). DSTERM may also be populated with a verbatim term, which is then standardized in DSDECOD.",8
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,9,DSSTDAT,Disposition Event Start Date,"The date of the specified protocol milestone (e.g., informed consent) represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the [protocol milestone/other event name] (start) date?,[Protocol Milestone/Other Event Name] (start) Date,Char,R/C,"Record the date of the protocol milestone/other event as defined in the protocol and/or CRF completion instructions, using this format (DD-MON-YYYY).",DSSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DSSTDTC in ISO 8601 format.",N/A,N/A,Applicants should define in the protocol and/or CRF completion instructions the criteria for completion of each protocol milestone/other event and its associated (start) date.,9
Events,DS,PROTOCOL MILESTONE/OTHER EVENT,N/A,10,DSSTTIM,Disposition Event Start Time,"The time of the specified protocol milestone (e.g., informed consent) or other event, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [protocol milestone/other event name] (start) time?,[Protocol Milestone/Other Event Name] (start) Time,Char,O,Record the time (as complete as possible) as defined in the protocol and/or CRF completion instructions.,DSSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DSSTDTC in ISO 8601 format.",N/A,N/A,Applicants should define in the protocol and/or CRF completion instructions the criteria for completion of each protocol milestone/other event (start) time. Collecting the time of the event is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail.,10
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.",11
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be prepopulated.",12
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",13
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,4,DSCAT,Category for Disposition Event,"A categorization of the disposition events which is used to distinguish between disposition events, protocol milestones, and other events.",What was the category of the disposition?,[Disposition Category],Char,HR,"If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.",DSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(DSCAT),N/A,"This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. This is used to distinguish a DISPOSITION EVENT, a PROTOCOL MILESTONE, or an OTHER EVENT. In this implementation scenario, DSCAT=""DISPOSITION EVENT""",14
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,5,DSSCAT,Subcategory for Disposition Event,A sub-division of the DSCAT values based on user-defined characteristics.,What was the subcategory of the disposition?,[Disposition Subcategory]; NULL,Char,O,"If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.",DSSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. DSSCAT can only be used if there is an DSCAT, and it must be a subcategorization of the Disposition event.",15
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,6,EPOCH,Epoch,"Trial epoch (e.g., '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 tabulation variable listed in the Tabulation Target column.,(EPOCH),N/A,"If disposition events are collected more than once in the study, EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as part of the title of the page; however, some companies have a standard CRF module that includes a pick-list of epochs.",16
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,7,DSDECOD,Standardized Disposition Term,"The standardized terminology of the disposition term that describes whether a subject completed the study or a portion of a study (epoch), or the reason they did not complete.",What was the subject's status (at the EPOCH/study specific time frame)?,Status (at the EPOCH/study specific time frame),Char,R/C,"Document the subject's status at [insert text corresponding to the selected trial epoch/study specific time frame]. If the subject discontinued prematurely, record the primary reason for discontinuation.",DSDECOD,"Maps directly to the tabulation variable listed in the Tabulation Target column. Both DSDECOD and DSTERM must be populated in the tabulation datasets. If DSTERM was collected as an ""Other, Specify"" free text, populate DSTERM with the free text and populate DSDECOD with the applicant-defined standardized text. If DSDECOD was collected with no free text, populate DSTERM and DSDECOD in the tabulation dataset with the DSDECOD value that was collected.",(TNCOMPLT),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 applicant- and/or study-specific reasons for discontinuation, it is recommended that these reasons be pre-printed on the CRF, as subcategories of the appropriate standardized DSDECOD item. However, it is recommended to limit the use of applicant and study-specific reasons in order to promote consistent use of terminology and permit the combination of data across multiple applicants. Either DSTERM or DSDECOD must be on the CRF. Both may be used if DSTERM is used as a Specify, Other field.",17
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,8,DSTERM,Reported Term for the Disposition Event,"The verbatim or pre-specified name of the event. The reported or pre-specified name for how a subject completed the study or a portion of a study (epoch), or the reason they did not complete.","What was the subject's status?; If [DSDECOD], specify",[Status]; [Specify],Char,R/C,"Document the subject's status at [insert text corresponding to the selected trial epoch]. If the subject discontinued prematurely, record the primary reason for discontinuation. (Or, if used with a DECOD list) If Other is selected from the Status list, provide the verbatim reason.",DSTERM,"Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variables DSDECOD and DSTERM must be populated in the tabulation dataset. If DSTERM was collected as an ""Other, Specify"" free text, populate the tabulation variable DSTERM with the free text and populate DSDECOD with the applicant-defined standardized text. If DSDECOD was collected with no free text, populate DSTERM and DSDECOD in the tabulation dataset with the DSDECOD value that was collected.",N/A,N/A,"If used with a DECOD list, free-text description of the subject's ""Other"" status. DSTERM is the verbatim term for subject status when Other is selected from the DSDECOD code list. This field would only be used with the prompt and completion instructions provided as a Specify, Other field in conjunction with DSDECOD. DSTERM may be used by itself when no code list is provided for DSDECOD on the CRF. Either DSTERM or DSDECOD must be on the CRF. DSTERM is required in the tabulation dataset.",18
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,9,DSSTDAT,Disposition Event Start Date,"The date of the specified disposition event (e.g., study completion or discontinuation), represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the disposition event date?,Disposition Event Date,Char,R/C,Record the date of disposition event as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY),DSSTDTC,"This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DSSTDTC in ISO 8601 format.",N/A,N/A,Applicants should define in the protocol and/or CRF completion instructions the criteria for completion of each epoch for which a Disposition CRF will be provided. Define also the date of completion or discontinuation. Only collect the date of the disposition event once.,19
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,10,DSSTTIM,Disposition Event Start Time,"The time of the specified disposition event (e.g., study completion or discontinuation), represented in an unambiguous time format (e.g., hh:mm:ss).",What was the disposition event time?,Disposition Event Time,Char,O,"Record the time (as complete as possible) that the subject completed the study or portion of the study as defined in the protocol and/or CRF completion instructions. If the subject did not complete the study or portion of the study, record the time (as complete as possible) as defined in the protocol and/or CRF completion instructions.",DSSTDTC,"This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DSSTDTC in ISO 8601 format.",N/A,N/A,"Applicants should define in the protocol and/or CRF completion instructions the criteria for completion of each epoch for which a Disposition CRF will be provided. Define also the date of completion or discontinuation. Collecting the time of completion or discontinuation is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. Typically, it is not recommended that a time be collected unless the subject is under the direct care of the site at the time of the event. Only collect the time of completion or discontinuation on the Disposition CRF module if the same information is not being collected on another CRF module.",20
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,11,DTHDAT,Death Date,Date of death for any subject who died.,What [is/was] the subject's date of death?,Death Date,Char,O,Record the date of death,DM.DTHDTC,"This field does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 SDTM. It may be collected on any CRF deemed appropriate by the applicant, but should only be collected once. The tabulation variable DTHDTC is mapped to the DM domain during the tabulation dataset creation process. The tabulation variable DM.DTHFLG is not a collection variable, but is populated during the tabulation dataset creation process. Death Date may also be mapped to other tabulation domains (e.g., DS) as deemed appropriate by the applicant.",21
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,12,DSCONT,Subject Continue,The plan for subject continuation to the next phase of the study or another study at the time of completion of the CRF.,Will the subject continue?,Subject Continue,Char,O,Record if the subject will be continuing to [the next phase of this study/related study] (applicant to specify as appropriate).,SUPPDS.QVAL,This information could be represented in a SUPPDS dataset as the value of SUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue".,(NY),N/A,"Applicants should specify the next phase of the study or the related study on the CRF. Typically this is a prompt to aid in monitoring and data cleaning, and usually not represented in a SUPPDS dataset.",22
Events,DS,STUDY PARTICIPATION DISPOSITION EVENT,N/A,13,DSNEXT,Next EPOCH,Identifies the study epoch or new study in which the subject will participate.,What is the next [epoch/period/study/trial] the subject will [continue to/enter/enroll]?,Next [Epoch/Period/Study/Trial],Char,O,Record the planned subsequent [study epoch/study] in which the subject intends to participate.,N/A,Applicant-defined tabulation mapping.,N/A,N/A,"Applicants 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 tabulation dataset mapping rules are provided because the mapping depends on the situation (e.g., next epoch, next trial). Per applicant decision, plans to enter the next epoch within a study may be included in the tabulation datasets (e.g., SE). Actual subject entry into the next study is represented as part of Trial Design datasets of that study.",23
Events,EM,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included into the database or populated during tabulation dataset creation.",1
Events,EM,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed for the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Events,EM,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,R/C,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected for all domains. However, this collection variable is populated only in the tabulation DM dataset. R/C rather than HR because events may happen to or with a device that do not involved subjects, and may even be before the device was in contact with a subject.",3
Events,EM,N/A,N/A,4,SPTOBID,Applicant-Defined Tobacco Product ID,Applicant-Defined Tobacco Product ID,[Applicant-defined question],[Applicant-Defined Tobacco Product ID],Char,HR,Record the identifier for the study device.,SPTOBID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product.,4
Events,EM,N/A,N/A,5,EMYN,Any Tobacco Device Event,An indication of whether any tobacco device events were experienced during the study.,Were any tobacco device events experienced?,Any Tobacco Device Events,Char,O,"Indicate if the subject experienced any tobacco device events. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to an tabulation variable.,(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.,5
Events,EM,N/A,N/A,6,EMCAT,Category for Device Event,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the device Event?,[Device Event Category]; NULL,Char,O,"Record the device event category, if not pre-printed on the CRF.",EMCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading.",6
Events,EM,N/A,N/A,7,EMSCAT,Subcategory for Device Event,A sub-division of the EMCAT values based on user-defined characteristics.,What is the subcategory of the device event?,[Device Event Subcategory]; NULL,Char,O,"Record the device event subcategory, if not pre-printed on the CRF.",EMSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. EMSCAT can only be used if there is an EMCAT and it must be a subcategorization of EMCAT.,7
Events,EM,N/A,N/A,8,EMSPID,EM Applicant Defined Identifier,"An applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field.",[Applicant-defined question],[Applicant defined],Char,O,"If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.",EMSPID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is an applicant-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 or device events. If CMAENO or PRAENO is used, this is the identifier to which CMAENO or PRAENO refers. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the applicant's data collection system.",8
Events,EM,N/A,N/A,9,EMTERM,Reported Term for the Device Event,The reported or pre-specified name of the device event.,What is the device event term?,Device Event,Char,HR,Record only 1 device event. Use accepted terminology.,EMTERM,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Can be represented either as an open-entry field to capture verbatim terms reported by subjects or pre-printed, in the situation where solicited device events of interest are captured. In most cases, the verbatim term (i.e. investigator-reported term) will be coded to a a standard dictionary.",9
Events,EM,N/A,N/A,10,EMOCCUR,Device Event Occurrence,An indication of whether a pre-specified device event or a group of device events occurred when information about the occurrence of a specific event is solicited.,Did the subject have [pre-specified device event/group of device events]?,[Specific Device Event],Char,O,"Indicate if [specific Device Event] has occurred/is occurring, by checking Yes or No.",EMOCCUR,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,The collection variable EMOCCUR is used to indicate the occurrence of pre-specified device events (e.g. "Did the the device batteries malfunction? \n EMOCCUR should not be used for spontaneously reported device events. The site should be able to indicate that the response was not asked or answered.,10
Events,EM,N/A,N/A,11,EMPRESP,Pre-specified Device Event,An indication that a specific event or group of events are pre-specified on a CRF.,N/A,N/A,Char,O,N/A,EMPRESP,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"A hidden field on a CRF defaulted to ""Y"", or added during tabulation dataset creation, when the EMis pre-specified. Null for spontaneously reported events. If a study collects both pre-specified and free-text device events, the value of EMPRESP should be ""Y"" for all pre-specified events and null for events reported as free-text. EMPRESP is a permissible field. and may be omitted from the tabulation dataset if all events were collected as free text.",11
Events,EM,N/A,N/A,12,EMSTDAT,Device Event Start Date,"The start date of the device event, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What is the device event start date?,Start Date,Char,HR,Record the start date of the device event using this format (DD-MON-YYYY).,EMSTDTC,"This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable EMSTDTC in ISO 8601 format.",N/A,N/A,N/A,12
Events,EM,N/A,N/A,13,EMSTTIM,Start Time of Device Event,"The start time of the device event, represented in an unambiguous time format (e.g., hh:mm:ss).",What is the device event start time?,Start Time,Char,R/C,Record the start time (as complete as possible) of the device event.,EMSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable EMSTDTC in ISO 8601 format.",N/A,N/A,Collecting the time an event 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.,13
Events,EM,N/A,N/A,14,EMONGO,Ongoing Device Event,Indication that an device event is ongoing when no end date is provided.,Is the device 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 device event has not resolved at the time of data collection; leave the End Date blank.,EMENRTPT; EMENRF,"This does not map directly to an tabulation variable. May be used to populate a value into a tabulation relative timing variable such as EMENRF or EMENRTPT. When populating EMENRF, if the value of EMONGO is ""Y"", the value of ""DURING"", ""AFTER"" or ""DURING/AFTER"" may be used. When populating EMENRTPT, if the value of EMONGO is ""Y"", the value of ""ONGOING"" may be used. When EMONGO refers to the Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the tabulation variable EMENRF should be populated. When EMONGO is compared to another time point, the tabulation variables EMENRTPT and EMENTPT should be used. Note: EMENRTPT must refer to a time-point anchor described in EMENTPT.",(NY),N/A,"Completed to indicate that the event 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 Outcome. The purpose of collecting this field is to help with data cleaning and monitoring; this field provides further confirmation that End Date was deliberately left blank. Often used as a tick/checkbox.",14
Events,EM,N/A,N/A,15,EMENDAT,Device Event End Date,"The date when the device event resolved/ended, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the device event end date?,End Date,Char,R/C,"Record the date that the device event. resolved using this format (DD-MON-YYYY). If the EMis ongoing, leave the field blank.",EMENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable EMENDTC in ISO 8601 format.",N/A,N/A,"The definition of resolved is applicant-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.",15
Events,EM,N/A,N/A,16,EMENTIM,End Time of Device Event,"The time when the Device Event ended/resolved, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the Device Event end time?,End Time,Char,R/C,Record the time (as complete as possible) that the Device Event resolved.,EMENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable EMENDTC in ISO 8601 format.",N/A,N/A,Collecting the time an event 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.,16
Events,EM,N/A,N/A,17,EMSEV,EM Severity/Intensity,The severity or intensity of the event.,What is the severity of the device event?,Severity,Char,R/C,The reporting physician/healthcare professional will assess the severity of the event using the applicant-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use judgment to compare the reported device event to similar type events observed. Severity is not equivalent to seriousness.,EMSEV,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,N/A,17
Events,EM,N/A,N/A,18,EMACNDEV,Actions Taken with Device,"A description of the action taken, with respect to a device used in a study (which may or may not be the device under study), as a result of the event.",What action was taken with a device used in the study?,Action Taken with Device,Char,O,Record actions taken resulting from the device event that are related to a study or non-study device.,EMACNDEV,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology for actions that are related to the device. Action Taken may include device replacement, battery replacement, etc.",18
Events,EM,N/A,N/A,19,EMSI,Device Event of Special Interest,"An device event of special interest (serious or non-serious) is one of scientific and medical concern specific to the applicant's product or program, for which ongoing monitoring and rapid communication by the investigator to the applicant 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 study applicant to other parties (e.g., regulators) might also be warranted.",Is this event of special interest?,Device Event of Special Interest,Char,O,Record the investigator's opinion as to whether the event is an device event of special interest by the applicant.,N/A,Does not map to a tabulation variable.,(NY),N/A,"This collection field may be used just to trigger other CRF pages, or populate a value in EMCAT or EMSCAT. This information could be represented in a SUPPEM dataset where SUPPEM.QNAM = ""EMSI"" and SUPPEM.QLABEL = ""Device Event of Special Interest.",19
Events,EM,N/A,N/A,20,EMPATT,Pattern of Device Event,Used to indicate the pattern of the event over time.,What is the device event pattern?,Pattern,Char,O,"For each device event, check the pattern of the device event, If a single event, choose Single.",EMPATT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Used to report the pattern of the EM (e.g.,""INTERMITTENT"", ""CONTINUOUS"", ""SINGLE EVENT""). For crossover studies, it is NOT recommended to capture this field for intermittent events. Instead, the corresponding start and stop dates should be captured.",20
Events,EM,N/A,N/A,21,EMMODIFY,EM Modified Reported Term,"If the value for EMTERM is modified to facilitate coding, then EMMODIFY will contain the modified text.",N/A,N/A,Char,R/C,N/A,EMMODIFY,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This is not a data collection field that would appear on the CRF. applicants will populate this through the coding process.,21
Events,EM,N/A,N/A,22,EMDECOD,EM Dictionary-Derived Term,"The dictionary or standardized text description of EMTERM or the modified topic variable (EMMODIFY), if applicable.",N/A,N/A,Char,O,N/A,EMDECOD,Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant 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. applicants will populate this through the coding process.,22
Findings About Events or Interventions,FA,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",1
Findings About Events or Interventions,FA,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings About Events or Interventions,FA,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings About Events or Interventions,FA,N/A,N/A,4,VISIT,Visit Name,"The name of an 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings About Events or Interventions,FA,N/A,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an tabulation variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the collection VISDAT/VISTIM components and populating the tabulation variable FADTC in ISO 8601 format.",N/A,N/A,"The date the finding about measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the FA CRF using the Findings About Date (FADAT) field.",5
Findings About Events or Interventions,FA,N/A,N/A,6,FAOBJ,Findings About Object of the Observation,A description of the object or focal point of the findings observation that is represented by FATEST.,"[Applicantsdt,-defined phrase]",[Applicant-defined phrase],Char,HR,[Protocol-specific],FAOBJ,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The FAOBJ will usually be pre-printed or hidden, not solicited as an actual question. These FA domains are usually created by the applicant.",6
Findings About Events or Interventions,FA,N/A,N/A,7,FAYN,Findings About Collected,An indication of whether data was collected for the finding topic.,Has the subject had any [Findings topic(s)] (after/before [study specific time frame])?; [Was/Were] (there) any [Findings topic(s)] (reported) (after/before [study specific time frame])?; Were all eligibility criteria met?,Any [Finding Topic],Char,O,"Indicate if the there are findings. If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to a tabulation variable.,(NY),N/A,"This is a field that can be used in any CRF to indicate whether there is data to record. Used primarily as a data cleaning field, it provides verification that all other fields on the CRF were deliberately left blank. FAPERF should be used to capture a response about whether planned measurements, tests, or observations were done.",7
Findings About Events or Interventions,FA,N/A,N/A,8,FAPERF,Findings About Performed,"An indication of whether a planned measurement, series of measurements, test, observation or specimen was performed or collected.",[Were any/Was the] [FATEST/topic] ([measurement(s)/test(s)/examination(s)/specimen(s)/sample(s))] [performed/collected]?,([FATEST/ topic] ([Measurement (s)/Test(s)/Examination(s)/Specimen(s)/Sample(s)]) [Performed/Collected]?,Char,O,"Indicate if the [FATESTs] was/were collected. If Yes, include the appropriate details where indicated on the CRF.",FASTAT,"This field does not map directly to an tabulation variable. May be used to populate a value into the tabulation variable FASTAT. If the collection variable FAPERF=""N"", the value of the tabulation variable FASTAT is ""OT DONE"". If FAPERF=""Y"", FASTAT is null. A combination of tabulation variables (e.g., FACAT and FASCAT, FATPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable FATESTCD would be populated with FAALL and an appropriate test name (FATEST) provided.",(NY),N/A,"This field is used to capture a response to whether a planned measurement, test or observation was performed. A negative response can be collected as ""N"" and mapped to the tabulation FASTAT variable as ""NOT DONE"".",8
Findings About Events or Interventions,FA,N/A,N/A,9,FADAT,Findings About Assessment Date,"The date when the findings about assessment was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the findings about assessment was performed?,Date,Char,R/C,Record date of measurements using this format (DD-MON-YYYY).,FADTC,"This field does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable FADTC in ISO 8601 format.",N/A,N/A,"The date the FA measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the FA CRF using the Date of Collection (FADAT) field.",9
Findings About Events or Interventions,FA,N/A,N/A,10,FATIM,Findings About Assessment Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the findings about assessment?,Time,Char,R/C,Record time of measurement (as complete as possible).,FADTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable VSDTC in ISO 8601 format.",N/A,N/A,Collect time if it is relevant for the analysis.,10
Findings About Events or Interventions,FA,N/A,N/A,11,FATEST,Findings About Test Name,Descriptive name for the test being performed.,What [is/was] the name (of the [measurement/test/examination])?,[Measurement/Test/Examination/] (Name),Char,HR,"Record the name of the FATEST if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",FATEST; FATESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable FATESTCD may be determined from the value collected in FATEST.,N/A,N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",11
Findings About Events or Interventions,FA,N/A,N/A,12,FATSTDTL,Findings About Test Detail,A further description of FATESTCD and FATEST.,What [is/was] the [measurement/test/examination] detail name?,[Measurement/Test/Examination] Detail (Name),Char,O,"Record the detail of the [FATEST], if not pre-printed on the CRF.",FATSTDTL,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"It is recommended that the test detail name be pre-printed on the CRF. If the form is laid out as a grid, then words such as ""Test,"" ""Test Name"" can be included in the column heading.",12
Findings About Events or Interventions,FA,N/A,N/A,13,FACAT,Category for Findings About,A grouping of topic-variable values based on user-defined characteristics.,What [is/was] the [type/category/name] (of the [measurement/test/examination/specimen/sample])?,[Category/Category Value]; NULL,Char,O,"Record the FA category, if not pre-printed on the CRF.",FACAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",13
Findings About Events or Interventions,FA,N/A,N/A,14,FASCAT,Subcategory for Findings About,A sub-division of the FACAT values based on user-defined characteristics.,What [is/was] the [type/subcategory/name] (of the [measurement/test/examination/specimen/sample])?,[FA Subcategory/FA Subcategory Value]; NULL,Char,O,"Record the FA subcategory, if not pre-printed on the CRF.",FASCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. FASCAT can only be used if there is an FACAT, and it must be a subcategorization of FACAT.",14
Findings About Events or Interventions,FA,N/A,N/A,15,FAPOS,Findings About Position of Subject,The position of the subject during a measurement or examination.,In what position was the subject during the [measurement/ test/examination/specimen collection/sample collection]?; What was the position of the subject (during the [measurement/test/examination/specimen collection/sample collection])?,Position,Char,O,Record the position of the subject during the FA test.,FAPOS,Maps directly to the tabulation variable listed in the Tabulation Target column.,(POSITION),N/A,N/A,15
Findings About Events or Interventions,FA,N/A,N/A,16,FAORRES,FA Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What [is/was] the [result/amount/(subject's) characteristic] (of the [measurement/test/examination/question/assessment])?,([Result/Amount] of) [value from FATEST],Char,HR,Record the FATEST result.,FAORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,16
Findings About Events or Interventions,FA,N/A,N/A,17,FAORRESU,FA Original Units,The unit of the result as originally received or collected.,What [is/was] the unit (of the [measurement/test/examination])?,Unit,Char,R/C,"Select the unit of measure associated with the test, or record if not pre-printed on the CRF.",FAORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere.",17
Findings About Events or Interventions,FA,N/A,N/A,18,FAORNRLO,FA Normal Range Lower Limit- Orig Unit,The lower end of normal range or reference range for continuous results stored in FAORRES.,What [is/was] the lower limit of the reference range (for the [measurement/test/examination])?,Normal Range Lower Limit,Char,O,Record the lower limit of the reference range of the FA test.,FAORNRLO,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"--ORNRLO should be populated only for continuous findings. The tabulation variable --STNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment, or could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.",18
Findings About Events or Interventions,FA,N/A,N/A,19,FAORNRHI,FA Normal Range Upper Limit- Orig Unit,The upper end of normal range or reference range for continuous results stored in FAORRES.,What [is/was] the upper limit of the reference range (for the [measurement/test/examination])?,Normal Range Upper Limit,Char,O,Record the upper limit of the reference range of the FA test.,FAORNRHI,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"--ORNRHI should be populated only for continuous findings. The tabulation variable --STNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment, or could be derived from a site- or lab-specific set of normal ranges stored in a look-up table.",19
Findings About Events or Interventions,FA,N/A,N/A,20,FANRIND,Findings About Reference Range Indicator,An indication or description about how the value compares to the normal range or reference range.,How [did/do] the reported values compare within the [reference/normal/expected] range?,Comparison to [Reference/Expected/Normal] Range,Char,O,"Record where the test results were categorized within the respective reference range (e.g. HIGH, LOW, ABNORMAL).",FANRIND,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NRIND),N/A,"Reference ranges may be defined by FAORNRLO, FAORNRHI, FASTNRC or other objective criteria. Reference Range Indicator may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance.",20
Findings About Events or Interventions,FA,N/A,N/A,21,FASTAT,Findings About Completion Status,"This variable is used to indicate that data are not available, by having the site recording the value as ""Not Done"".",Was the [--TEST ] not [completed/answered/done/assessed/evaluated ]?; Indicate if the([--TEST] was) not [answered/assessed/done/evaluated/performed].,Not Done,Char,O,Indicate if the [FATEST] measurement was not done.,FASTAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ND),N/A,Used only when the response value is collected as NOT DONE or NULL in lieu of or in addition to the collection FAPERF field. Typically a checkbox which indicates the test was NOT DONE. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank.,21
Findings About Events or Interventions,FA,N/A,N/A,22,FAREASND,Findings About Reason Not Performed,An explanation of why data are not available.,Was the [is/was] the reason that the [Findings topic/data/information/applicant-defined phrase] was not [collected/answered/done/assessed/evaluated]?,Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available],Char,O,Provide the reason why an FA test was not collected.,FAREASND,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology may be used. The reason the data are not available may be chosen from applicant 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 tabulation dataset.",22
Findings About Events or Interventions,FA,N/A,N/A,23,FASPEC,Findings About Specimen Type,The type of specimen used for a measurement.,What [is/was] the specimen type?,Specimen Type,Char,O,Record the specimen material type.,FASPEC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",23
Findings About Events or Interventions,FA,N/A,N/A,24,FASPCCND,Findings About Specimen Condition,Description of the condition of the specimen.,What [is/was] the condition of the specimen?,Specimen Condition,Char,O,Record the condition of the specimen.,FASPCCND,Maps directly to the tabulation variable listed in the Tabulation Target column.,(SPECCOND),N/A,"May be collected using free or standardized text. Results may be affected by whether conditions for specimen were properly met. When local processing is used, applicants may not routinely collect specimen condition.",24
Findings About Events or Interventions,FA,N/A,N/A,25,FALOC,Location of the Finding About,"The anatomical location of the subject, relevant to the collection of the measurement.",What [is/was] the anatomical location (of the [measurement/test/examination]) or What [is/was] the anatomical location where the [measurement/specimen] was taken/collected)?,Anatomical Location,Char,O,"Record or select location on body where the measurement was performed, if not pre-printed on CRF.",FALOC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LOC),N/A,"Collected or pre-printed when the applicant needs to identify the specific anatomical location (e.g., ARM for blood pressure). Applicants may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, and PORTOT are used to further describe the anatomical location.",25
Findings About Events or Interventions,FA,N/A,N/A,26,FALAT,Laterality of Location of Finding About,"Qualifier for anatomical location, further detailing the side of the body.",What [is/was] the side (of the anatomical location of the [measurement/test/examination])?,Side,Char,O,Record the side of the anatomical location of the [FATEST] measurement.,FALAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LAT),N/A,May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.,26
Findings About Events or Interventions,FA,N/A,N/A,27,FADIR,Findings About Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What [is/was] the directionality (of the anatomical location of the [measurement/test/examination])?,Directionality,Char,O,Record the directionality.,FADIR,Maps directly to the tabulation variable listed in the Tabulation Target column.,(DIR),N/A,May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.,27
Findings About Events or Interventions,FA,N/A,N/A,28,FAPORTOT,FA Location Portion or Totality,"Qualifier for anatomical location, further detailing the distribution (i.e.,arrangement of, apportioning of).",What [is/was] the portion or totality (of the anatomical location of the [measurement/test/examination])?,Portion or Totality,Char,O,Indicate the portion or totality anatomical location.,FAPORTOT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(PORTOT),N/A,Collected when the applicant needs to identify the specific portionality for the anatomical locations of the location of the FATEST. Applicants may collect the data using a subset list of controlled terminology on the CRF.,28
Findings About Events or Interventions,FA,N/A,N/A,29,FAMETHOD,Findings About Method,Method of the test or examination.,What was the method (used for the [measurement/test/examination])?,Method,Char,O,"Record the method used for the measurement, test, or examination.",FAMETHOD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(METHOD),N/A,N/A,29
Findings About Events or Interventions,FA,N/A,N/A,30,FALEAD,Findings About Lead,The lead or leads identified to capture the measurement for a test from an instrument.,What [is/was] the lead (used to measure [measurement/test/examination])?,Lead,Char,O,Record the lead used for measurement.,FALEAD,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,N/A,30
Findings About Events or Interventions,FA,N/A,N/A,31,FAFAST,Findings About Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,[Is/Was] the subject fasting (prior to the [test being performed/sample being collected])?,Fasting,Char,O,Record whether the subject was fasting prior to the test being performed.,FAFAST,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,31
Findings About Events or Interventions,FA,N/A,N/A,32,FAEVAL,Findings About Evaluator,The role of the person providing the evaluation.,Who provided the (applicant-defined phrase) information?; Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, VENDOR).",FAEVAL,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed, or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.",32
Findings About Events or Interventions,FA,N/A,N/A,33,FAEVALID,Findings About Evaluator Identifier,An identifier used to distinguish multiple evaluators with the same role recorded in FAEVAL.,What [is/was] the identifier of the [evaluator name/reporter name] (providing the-applicant-defined phrase-information)?,[Evaluator/Reporter] Identifier,Char,O,Record the unique identifier assigned to the person making the evaluation.,FAEVALID,Maps directly to the tabulation variable listed in the Tabulation Target column.,(MEDEVAL),N/A,This variable is used in conjunction with FAEVAL to provide an additional level of detail.,33
Findings About Events or Interventions,FA,N/A,N/A,34,FACLSIG,Findings About Clinical Significance,An indication whether the test results were clinically significant.,[Is/Was] the ([measurement/test/examination]) result clinically significant?,([Measurement/Test/Examination/])/Clinically Significant,Char,O,Record whether the [FATEST] result was clinically significant.,SUPPFA.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPFA dataset as the value of SUPPFA.QVAL when SUPPFA.QNAM = "CLSIG" and SUPPFA.QLABEL = "Clinical Significance".,(NY),N/A,N/A,34
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,DA,N/A,Horizontal-Generic,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated.This variable collection is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings,DA,N/A,Horizontal-Generic,4,VISIT,Visit Name,"The name of a clinical encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column..,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,DA,N/A,Horizontal-Generic,5,VISDAT,Visit Date,Date the clinical encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable DADTC in ISO 8601 format.",N/A,N/A,"The date the 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,Product Accountability Group ID,An applicant-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. Applicant may insert additional instructions to ensure each record has a unique group identifier.,DAGRPID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,It can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This group identifier ties together all the tests collected on this horizontal record. This field may be populated by the applicant's data collection system.,6
Findings,DA,N/A,Horizontal-Generic,7,[DATESTCD]_DAPERF,Product Accountability Performed,An indication of whether a planned product accountability assessment was performed.,Was [DATEST] collected?,[DATEST] Collected,Char,O,Indicate whether or not product accountability was performed.,DASTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable DASTAT. If DAPERF=""N"", the value of DASTAT will be ""NOT DONE"". If DAPERF=""Y"", DASTAT should be null. A combination of tabulation variables ( e.g., DACAT and DASCAT, DATPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable DATESTCD would be populated as DAALL and an appropriate test name (DATEST) provided.",(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 the tabulation dataset, the value of DAPERF would apply to all tests on the same record. Use the collection variable [DATESTCD]_DAPERF when implemented on a specific test basis. This is an example of the type of collection variable names that can be used in a denormalized data structure.",7
Findings,DA,N/A,Horizontal-Generic,8,[DATESTCD]_DACAT,DA Category of Assessment,A grouping of topic-variable values based on user-defined characteristics.,What was the type of product for which accountability was assessed?,Product Type,Char,O,Record the type of study product for which accountability is assessed.,DACAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. If the protocol allows dispensing different types of study product the CRF can capture the type of product using DACAT. This may be pre-printed on the CRF. If DACAT is not collected (e.g., it is evident from the protocol design), it could be populated during the tabulation dataset creation process. The value of DACAT would apply to all measurements on that record when mapped to the tabulation dataset. If needed, the collection variable [DATESTCD]_DACAT may be used to collect a category for each DATEST.",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 product for which accountability was assessed?,[DATEST] Product Name,Char,O,Record the name of the study product dispensed.,DASCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a category value pre-printed on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column header. If known at the time of data collection, the product name may be collected in DASCAT (with appropriate grouping values, but different from those for DACAT). The value of DASCAT would apply to all measurements on that record when mapped to the tabulation dataset. If needed, the collection variable [DATESTCD]_DASCAT may be used to collect a category for each DATEST.",9
Findings,DA,N/A,Horizontal-Generic,10,[DATESTCD]_DAREFID,Product Accountability Reference ID,An internal or external identifier such as product label identifier.,What is the [DATEST] product label identifier?,[DSTEST] Product Label Identifier,Char,O,Record dispensed product label identifier.,DAREFID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in EX domain.,N/A,N/A,"The packaging identifier may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some cases, greater granularity for product identifiers may be needed. In this situation, applicants may need to use additional variables. This is an example of the type of collection variable names that can be used in a denormalized data structure.",10
Findings,DA,N/A,Horizontal-Generic,11,[DATESTCD]_DADAT,Product Accountability Date of Assessment,"The date the study product was dispensed or returned, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date [DATEST] product accountability was assessed?,[DATEST] Date,Char,R/C,"Record the date product accountability was performed, using this format (DD-MON-YYYY).",DADTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DADTC in ISO 8601 format.",N/A,N/A,The date study product dispensed/returned should be recorded for each dispensation for a study with multiple periods or multiple products dispensed. A single date may be collected when all observations are performed on the same date. The date of each observation can also be collected using the collection variable [DATESTCD]_DADAT. The date of the observation may be determined from a collected date of visit and in such cases a separate measurement date field is not required. This is an example the type of collection variable names that can be used in a denormalized data structure.,11
Findings,DA,N/A,Horizontal-Generic,12,[DATESTCD]_DAORRES,DA Assessment Result in Original Units,"Result of the product accountability assessment (e.g., actual amount).",What is the amount of the [DATEST] product accountability assessment?,[DATEST] Amount,Char,HR,Record the result of the product accountability assessment.,DAORRES; DATEST; DATESTCD,"Maps directly to the tabulation variable listed in the Tabulation Target column. In addition to the tabulation variable DAORRES, create DATESTCD from the collection variable name and derive the value of DATEST from DATESTCD. The prompt may also contain DATEST. Use appropriate CDISC Controlled Terminology for the test and test code.",N/A,N/A,"Each test may be collected using the collection 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, accountability amounts should be assessed for each dispensation and return. For the tabulation dataset, DAREFID should be used to link related records. This is an example of the types of collection variable names that can be used in a denormalized data structure.",12
Findings,DA,N/A,Horizontal-Generic,13,[DATESTCD]_DAORRESU,DA Original Units,The unit of the result as originally received or collected.,What was the unit of the [DATEST] result?,[DATEST] Unit,Char,HR,"Record or select the original units in which these data were collected, if not pre-printed on CRF.",DAORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),(DAORRESU),The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. This is an example of the types of collection variable names that can be used in a denormalized data structure.,13
Findings,DA,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",15
Findings,DA,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What is the subject identifier?,Subject,Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation domain.",16
Findings,DA,N/A,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",17
Findings,DA,N/A,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable DADTC in ISO 8601 format.",N/A,N/A,"The date the 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,Product Accountability Performed,An indication of whether a planned product accountability assessment was performed.,Was product accountability performed?,Product Accountability Performed,Char,O,Indicate whether or not product accountability was performed.,DASTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable DASTAT. If DAPERF=""N"", the value of DASTAT will be ""NOT DONE"". If DAPERF=""Y"", DASTAT should be null. A combination of tabulation variables ( e.g., DACAT and DASCAT, DATPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable DATESTCD would be populated as DAALL and an appropriate test name (DATEST) provided.",(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 product for which accountability was assessed?,[Product Type]; NULL,Char,O,Record the type of product dispensed/returned.,DACAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer.,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 product for which product accountability was assessed?,[Product Name]; NULL,Char,O,Record the name of the study product dispensed/returned.,DASCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. If known at the time of data collection, the product name may be collected in DASCAT (with appropriate grouping values, but different from those for DACAT). See tabulation DA domain examples for populating DACAT and DASCAT. DASCAT can only be used if there is an DACAT, and it must be a subcategorization of DACAT.",21
Findings,DA,N/A,N/A,9,DADAT,Product Accountability Date,"The date the study product was dispensed or returned, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the product accountability assessment was performed?,Date,Char,R/C,"Record the exact date the study product was (dispensed or returned), using this format (DD-MON-YYYY).",DADTC,"This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DADTC in ISO 8601 format.",N/A,N/A,The date investigational product 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,Product Accountability Reference ID,An internal or external identifier such as product label identifier.,What was the product label identifier?,Product Label Identifier,Char,O,Record product label identifier.,DAREFID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"For the tabulation dataset, DAREFID should be used to tie together a block of related records and to link dispensed product to returned product. The packaging identifier may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some cases, greater granularity for product identifiers may be needed. In this situation, applicants 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 product accountability being assessed?,[Product Accountability Test Name],Char,HR,"Record the name of the product accountability assessment if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",DATEST; DATESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable DATESTCD may be determined from the value collected in the collection field DATEST. The tabulation variables DATESTCD and DATEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(DATEST),N/A,"Required to identify which test the result is for. It is recommended that the test names pre-printed on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as ""Test"" can be included as the column heading. For a study with multiple periods or multiple products dispensed, product 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 product accountability assessment as originally dispensed or returned (e.g., actual amount).",What is the result of the product accountability assessment?,Amount,Char,HR,Record the actual amount of product dispensed or returned.,DAORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"For a study with multiple periods or multiple products dispensed, product accountability amounts should be assessed for each dispensation.",25
Findings,DA,N/A,N/A,13,DAORRESU,DA Original Units,The unit of the result as originally received or collected.,What was the unit?,Unit,Char,HR,"Record or select the original units in which these data were collected, if not pre-printed on CRF.",DAORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),(DAORRESU),"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.",26
Findings,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,EG,Central Reading,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This variable collection is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings,EG,Central Reading,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,EG,Central Reading,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable EGDTC in ISO 8601 format.",N/A,N/A,"The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field.",5
Findings,EG,Central Reading,N/A,6,EGCAT,Category for ECG,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the ECG finding?,[ECG Category]; NULL,Char,O,"Record the ECG finding category, if not pre-printed on the CRF.",EGCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as &quot;Category&quot; can be included as the column header.",6
Findings,EG,Central Reading,N/A,7,EGSCAT,Subcategory for ECG,A sub-division of the EGCAT values based on user-defined characteristics.,What was the subcategory of the ECG finding?,[ECG Subcategory]; NULL,Char,O,"Record the ECG finding subcategory, if not pre-printed on the CRF.",EGSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as &quot;Subcategory&quot; can be included as the column header EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT.",7
Findings,EG,Central Reading,N/A,8,EGPERF,ECG Performed,"An indication of whether a planned ECG measurement, series of ECG measurements, tests, or observations was performed.",Was the ECG performed?,ECG Performed,Char,HR,Indicate whether or not an ECG or specific ECG test was done.,EGSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable EGSTAT. If the collection field EGPERF= &quot;N&quot;, the value of EGSTAT will be &quot;NOT DONE&quot;. If EGPERF = &quot;Y&quot;, EGSTAT should be null. A combination of tabulation variables (e.g., EGCAT and EGSCAT, EGTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided.",(NY),N/A,"This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",8
Findings,EG,Central Reading,N/A,9,EGREPNUM,ECG Repetition Number,"The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample).",Which repetition of the ECG is this?,Repetition number,Char,O,Record which repetition of the ECG this is.,EGREPNUM,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"If there are multiple ECGs, this is used to record in which order this ECG occurred.",9
Findings,EG,Central Reading,N/A,10,EGREFID,ECG Reference ID,"An internal or external identifier of the ECG (e.g., waveform number).",What was the (ECG) [reference identifier/accession number]?,(ECG) [Reference Identifier/Accession Number],Char,O,Record the identifier number assigned.,EGREFID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer if this reference ID happens to be available to the site at the time of collection. It can also be used to link the clinical significance assessment to the proper record in the electronic data. (e.g., UUID for external waveform file, session number automatically generated by electronic equipment).",10
Findings,EG,Central Reading,N/A,11,EGMETHOD,Method of ECG Test,Method of the test or examination.,What was the method used for the ECG?,Method,Char,O,Record the method used for the ECG.,EGMETHOD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EGMETHOD),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One possible condition is the method used to collect or calculate the ECG data. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF: \n * Method of ECG is provided as part of the electronic data. \n * Method of ECG is not pertinent to the protocol. \n * The protocol specifies only 1 possible method for collecting ECG measurements and the applicant does not feel there is significant risk of the sites performing the ECG using the incorrect method.",11
Findings,EG,Central Reading,N/A,12,EGLEAD,ECG Lead Location Used for Measurement,"The lead used for the measurement (e.g., &quot;LEAD I&quot;, &quot;LEAD II&quot;, &quot;LEAD III&quot;, &quot;LEAD rV2&quot;, &quot;LEAD V1&quot;)",Which lead location was used for this measurement?,Lead Location,Char,O,Record which lead was used for this measurement.,EGLEAD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EGLEAD),N/A,This is used when more specificity for the location is desired for the ECG data.,12
Findings,EG,Central Reading,N/A,13,EGPOS,ECG Position of Subject,The position of the subject during the ECG measurement.,What was the position of the subject during the ECG measurement?,Position,Char,O,Record the position of the subject during the ECG.,EGPOS,Maps directly to the tabulation variable listed in the Tabulation Target column.,(POSITION),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One common condition is the subject's position. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Position of the subject is provided as part of the electronic data.Position of the subject is not pertinent to the protocol.The protocol specifies only 1 possible position and the applicant does not feel there is significant risk of the sites performing the ECG with the subject in the wrong position.",13
Findings,EG,Central Reading,N/A,14,EGDAT,ECG Date,"The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the ECG?,ECG Date,Char,R/C,Record the date the ECG was done using this format (DD-MON-YYYY).,EGDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",14
Findings,EG,Central Reading,N/A,15,EGTPT,ECG Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol.,What was the planned time point of the ECG measurement?,[Planned Time Point Name],Char,R/C,"Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF.",EGTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as tabulation variables EGTPTNUM, EGELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as &quot;Planned Time Point&quot; can be included as the column header.",15
Findings,EG,Central Reading,N/A,16,EGTIM,ECG Time,"Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time the ECG was collected?,ECG Time,Char,R/C,Record the time the ECG was done (as complete as possible).,EGDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 product is required for analysis.,16
Findings,EG,Local Reading,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",17
Findings,EG,Local Reading,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",18
Findings,EG,Local Reading,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",19
Findings,EG,Local Reading,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",20
Findings,EG,Local Reading,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable EGDTC in ISO 8601 format.",N/A,N/A,"The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field.",21
Findings,EG,Local Reading,N/A,6,EGCAT,Category for ECG,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the ECG finding?,[ECG Category]; NULL,Char,O,"Record the ECG finding category, if not pre-printed on the CRF.",EGCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as &quot;Category&quot; can be included as the column header.",22
Findings,EG,Local Reading,N/A,7,EGSCAT,Subcategory for ECG,A sub-division of the EGCAT values based on user-defined characteristics.,What was the subcategory of the ECG finding?,[ECG Subcategory]; NULL,Char,O,"Record the ECG finding subcategory, if not pre-printed on the CRF.",EGSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as &quot;Subcategory&quot; can be included as the column header EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT.",23
Findings,EG,Local Reading,N/A,8,EGPERF,ECG Performed,"An indication of whether a planned measurement, series of measurements, test, or observation was performed.",Was the ECG performed?,ECG Performed,Char,HR,Indicate whether or not ECG or specific ECG test was done.,EGSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable EGSTAT. If the collection field EGPERF=&quot;N&quot;, the value of EGSTAT will be &quot;NOT DONE&quot;. If EGPERF=&quot;Y&quot;, EGSTAT should be null. A combination of tabulation variables ( e.g., EGCAT and EGSCAT, EGTPT ) is used to indicate that multiple tests were not done. In this situation, the tabulation variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided. nal information.",(NY),N/A,"This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",24
Findings,EG,Local Reading,N/A,9,EGREPNUM,ECG Repetition Number,"The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample).",What repetition of the ECG is this?,Repetition Number,Char,O,Record which repetition of the ECG this is.,EGREPNUM,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"If there are multiple ECGs, this is used to record in which order this ECG occurred.",25
Findings,EG,Local Reading,N/A,10,EGMETHOD,Method of ECG Test,Method of the test or examination.,What was the method used for the ECG?,Method,Char,O,Record the method used for the ECG.,EGMETHOD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EGMETHOD),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. One possible condition is the method used to collect or calculate the ECG data. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Method of ECG is provided as part of the electronic data.Method of ECG is not pertinent to the protocol.The protocol specifies only 1 possible method for collecting ECG measurements and the applicant does not feel there is significant risk of the sites performing the ECG using the incorrect method.",26
Findings,EG,Local Reading,N/A,11,EGLEAD,ECG Lead Location Used for Measurement,"The lead used for the measurement (e.g., &quot;LEAD I&quot;, &quot;LEAD II&quot;, &quot;LEAD III&quot;, &quot;LEAD rV2&quot;, &quot;LEAD V1&quot;).",Which lead location was used for this measurement?,Lead Location,Char,O,Record which lead was used for this measurement.,EGLEAD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EGLEAD),N/A,This is used when more specificity for the location is desired for the ECG data.,27
Findings,EG,Local Reading,N/A,12,EGPOS,ECG Position of Subject,The position of the subject during the ECG measurement.,What was the position of the subject during the ECG measurement?,Position,Char,O,Record the position of the subject during the ECG.,EGPOS,Maps directly to the tabulation variable listed in the Tabulation Target column.,(POSITION),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Position of the subject is provided as part of the electronic data.Position of the subject is not pertinent to the protocol.The protocol specifies only 1 possible position and the applicant does not feel there is significant risk of the sites performing the ECG with the subject in the wrong position.",28
Findings,EG,Local Reading,N/A,13,EGDAT,Date of ECG,"The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date of the ECG?,ECG Date,Char,R/C,Record the date ECG was done using this format (DD-MON-YYYY).,EGDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required.",29
Findings,EG,Local Reading,N/A,14,EGTPT,ECG Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol.,What was the planned time point of the ECG measurement?,[Planned Time Point Name],Char,R/C,"Record the time point labels for when the ECG test should be taken, if not pre-printed on the CRF.",EGTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as tabulation variables EGTPTNUM, EGELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as &quot;Planned Time Point&quot; can be included as the column heading.",30
Findings,EG,Local Reading,N/A,15,EGTIM,Time of ECG,"Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time the ECG was collected?,ECG Time,Char,R/C,Record the time the ECG was done (as complete as possible).,EGDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 product is required for analysis.,31
Findings,EG,Local Reading,N/A,16,EGTEST,ECG Test or Examination Name,Descriptive name of the measurement or finding.,What was the ECG test name?,[ECG Test Name],Char,HR,"Record the name of the ECG measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",EGTEST; EGTESTCD,Maps directly to the tabulation variable listed in the column with the heading Tabulation Target. The tabulation variable EGTESTCD may be determined from the value collected in EGTEST. The tabulation variables EGTESTCD and EGTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(EGTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as &quot;Test&quot; can be included as the column heading.",32
Findings,EG,Local Reading,N/A,17,EGORRES,ECG Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the ECG?,(Result),Char,HR,"Record test results, interpretations or findings.",EGORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,33
Findings,EG,Local Reading,N/A,18,EGORRESU,ECG Original Units,The unit of the result as originally received or collected.,What was the unit of the ECG results?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",EGORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),(EGORRESU),"May be included if quantitative results are recorded. Because units for quantitative ECG results are typically limited, units should be pre-printed on the CRF with the associated test when possible, rather than having sites record the units. This item is not necessary for qualitative results.",34
Findings,EG,Local Reading,N/A,19,EGCLSIG,ECG Clinical Significance,An indication of whether the ECG results were clinically significant.,Was the ECG clinically significant?,Clinically Significant,Char,O,Record whether ECG results were clinically significant.,SUPPEG.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPEG dataset as the value of SUPPEG.QVAL where SUPPEG.QNAM =&quot;EGCLSIG&quot; and SUPPEG.QLABEL=&quot;Clinically Significant&quot;.,(NY),N/A,Could apply to specific measurements or to overall interpretation.,35
Findings,EG,Central Reading with Investigator Assessment,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",36
Findings,EG,Central Reading with Investigator Assessment,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",37
Findings,EG,Central Reading with Investigator Assessment,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",38
Findings,EG,Central Reading with Investigator Assessment,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",39
Findings,EG,Central Reading with Investigator Assessment,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started),What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable EGDTC in ISO 8601 format.",N/A,N/A,"The date the ECG measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the ECG measurements at that visit, or the collection date can be included on the ECG CRF using the date (EGDAT) field.",40
Findings,EG,Central Reading with Investigator Assessment,N/A,6,EGCAT,Category for ECG,A grouping of topic-variable values based on user-defined characteristics,What was the category of the ECG finding?,[ECG Category]; NULL,Char,O,"Record the ECG finding category, if not on the CRF.",EGCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as &quot;Category&quot; can be included as the column heading.",41
Findings,EG,Central Reading with Investigator Assessment,N/A,7,EGSCAT,Subcategory for ECG,A sub-division of the EGCAT values based on user-defined characteristics,What was the subcategory of the ECG finding?,[ECG Subcategory]; NULL,Char,O,"Record the ECG finding subcategory, if not on the CRF.",EGSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as &quot;Subcategory&quot; can be included as the column heading. EGSCAT can only be used if there is an EGCAT, and it must be a subcategorization of EGCAT.",42
Findings,EG,Central Reading with Investigator Assessment,N/A,8,EGPERF,ECG Performed,"An indication of whether a planned measurement, series of measurements, test, or observation was performed",Was the ECG performed?,ECG Performed,Char,HR,Indicate whether or not an ECG or specific ECG test was done.,EGSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable EGSTAT. If the collection field EGPERF=&quot;N&quot;, the value of EGSTAT will be &quot;NOT DONE&quot;. If EGPERF=&quot;Y&quot;, EGSTAT should be null. A combination of tabulation variables (e.g., EGCAT and EGSCAT, EGTPT ) is used to indicate that multiple tests were not done. In this situation, the tabulation variable EGTESTCD would be populated as EGALL and an appropriate test name (EGTEST) provided.",(NY),N/A,"This may be implemented for an entire ECG, or a specific ECG test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",43
Findings,EG,Central Reading with Investigator Assessment,N/A,9,EGREPNUM,ECG Repetition Number,"The incidence number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a timepoint, within a visit; multiple measurements of blood pressure, multiple analyses of a sample).",Which repetition of the ECG is this?,Repetition Number,Char,O,Record which repetition of the ECG this is.,EGREPNUM,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"If there are multiple ECGs, this is used to record in which order this ECG occurred.",44
Findings,EG,Central Reading with Investigator Assessment,N/A,10,EGREFID,ECG Reference ID,"An internal or external identifier of the ECG (e.g., waveform number)",What was the (ECG) [reference identifier/accession number]?,(ECG) [Reference Identifier/Accession Number],Char,O,Record the identifier number assigned.,EGREFID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer if this reference ID happens to be available to the site at the time of collection. Examples: Universally Unique Identifier (UUID) for external waveform file, session number automatically generated by electronic equipment. This can also be used to link.",45
Findings,EG,Central Reading with Investigator Assessment,N/A,11,EGMETHOD,Method of ECG Test,Method of the test or examination,What was the method used for the ECG?,Method,Char,O,Record the method used for the ECG.,EGMETHOD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EGMETHOD),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the method used matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Method of ECG is provided as part of the electronic data.Method of ECG is not pertinent to the protocol.The protocol specifies only 1 possible method for collecting ECG measurements and the applicant does not feel there is significant risk of the sites performing the ECG using the incorrect method.",46
Findings,EG,Central Reading with Investigator Assessment,N/A,12,EGLEAD,ECG Lead Location Used for Measurement,"The lead used for the measurement (e.g., &quot;LEAD I&quot;, &quot;LEAD II&quot;, &quot;LEAD III&quot;, &quot;LEAD rV2&quot;, &quot;LEAD V1&quot;)",Which lead location was used for this measurement?,Lead Location,Char,O,Record which lead was used for this measurement.,EGLEAD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EGLEAD),N/A,This is used when more specificity for the location is desired for the ECG data.,47
Findings,EG,Central Reading with Investigator Assessment,N/A,13,EGPOS,ECG Position of Subject,The position of the subject during the ECG measurement,What was the position of the subject during the ECG measurement?,Position,Char,O,Record the position of the subject during the ECG.,EGPOS,Maps directly to the tabulation variable listed in the Tabulation Target column.,(POSITION),N/A,"Results may be affected by whether conditions for ECG as specified in the protocol were properly met. If the protocol requires this type of information, then this question may be included to confirm that the subject's position matches the protocol. The following are examples of when it is not necessary to collect these data on the CRF:Position of the subject is provided as part of the electronic data.Position of the subject is not pertinent to the protocol.The protocol specifies only 1 possible position and the applicant does not feel there is significant risk of the sites performing the ECG with the subject in the wrong position.",48
Findings,EG,Central Reading with Investigator Assessment,N/A,14,EGDAT,Date of ECG,"The date the ECG was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY)",What was the date of the ECG?,ECG Date,Char,R/C,Record the date ECG was done using this format (DD-MON-YYYY).,EGDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable EGDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and if so, a separate assessment date field is not required.",49
Findings,EG,Central Reading with Investigator Assessment,N/A,15,EGTPT,ECG Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol,What was the planned time point of the ECG measurement?,[Planned Time Point Name],Char,R/C,"Record the time point labels for when the ECG test should be taken, if not on the CRF.",EGTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time point anchors EGTPTREF (text description) and EGRFTDTC (date/time) may be needed, as well as tabulation variables EGTPTNUM, EGELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as &quot;Planned Time Point&quot; can be included as the column heading.",50
Findings,EG,Central Reading with Investigator Assessment,N/A,16,EGTIM,Time of ECG,"Time of ECG, represented in an unambiguous time format (e.g., hh:mm:ss)",What was the time the ECG was collected?,ECG Time,Char,R/C,Record the time the ECG was done (as complete as possible).,EGDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 product is required for analysis.,51
Findings,EG,Central Reading with Investigator Assessment,N/A,17,EGEVAL,ECG Evaluator,The role of the person who provided the evaluation,Who provided the information?; Who was the evaluator?,[Evaluator/Reporter],Char,O,"Select the role of the person who provided the evaluation (e.g., INVESTIGATOR, ADJUDICATION COMMITTEE, VENDOR).",EGEVAL,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be pre-printed or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.",52
Findings,EG,Central Reading with Investigator Assessment,N/A,18,INTP_EGORRES,ECG Interpretation,Overall interpretation of the result of the measurement or finding,What was the interpretation of the ECG?,Interpretation,Char,O,Record overall interpretations of the ECG.,EGORRES,"This does not map directly to a tabulation variable. For the tabulation dataset, the recorded interpretation is populated into the tabulation variable EGORRES where EGTEST= &quot;Interpretation&quot;, and EGTESTCD=&quot;INTP&quot;.",N/A,N/A,The overall interpretation of an ECG is mapped into the appropriate tabaulation test and result variables.,53
Findings,EG,Central Reading with Investigator Assessment,N/A,19,EGCLSIG,ECG Clinical Significance \n,An indication of whether the ECG results were clinically significant,Was the ECG clinically significant?,Clinically Significant,Char,HR,Record whether ECG results were clinically significant.,SUPPEG.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPEG dataset as the value of SUPPEG.QVAL where SUPPEG.QNAM = &quot;EGCLSIG&quot; and SUPPEG.QLABEL=&quot;Clinically Significant&quot;.,(NY),N/A,"Could apply to specific measurements or to overall interpretation. In this scenario, clinical significance could be provided by the investigator.",54
Findings,EG,Central Reading with Investigator Assessment,N/A,20,EGMHNO,Related Medical History Event ID,Identifier for the medical history event that was reported as a clinically significant ECG finding,What was the identifier for the medical history event that was reported as a clinically significant ECG finding?,Medical History Event Identifier,Char,O,Record the identifier for the medical history event that was reported as a clinically significant ECG finding.,N/A,"This does not map directly to a tabulation variable. For the tabulation datasets, may be used to create RELREC to link this record with a record in the MH domain.",N/A,N/A,Intent is to establish a link between the clinically significant ECG finding and the medical history event that was reported. EGMHNO can be used in RELREC to identify a relationship between records in EG dataset and records in the MH dataset.,55
Findings,EG,Central Reading with Investigator Assessment,N/A,21,EGAENO,Related Adverse Event ID,Identifier for the adverse event that was reported as a clinically significant ECG finding,What was the identifier for the adverse event(s) that was reported as a clinically significant ECG finding?,Adverse Event Identifier,Char,O,Record the identifier for the adverse event that was the reported as a clinically significant ECG finding.,N/A,"This does not map directly to a tabulation variable. For the tabulation datasets, may be used to create RELREC to link this record with a record in the AE domain.",N/A,N/A,Intent is to establish a link between the clinically significant ECG finding and the AE that was reported. EGAENO can be used to identify a relationship between records in EG dataset and records in the AE dataset.,56
Findings,IE,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,IE,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings,IE,N/A,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,IE,N/A,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using theis format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation 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 tabulation variable.,(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 tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable IEDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.",7
Findings,IE,N/A,N/A,8,IECAT,Inclusion/Exclusion Category,A grouping category to denote whether the protocol entry criterion being assessed is inclusion criteria or exclusion criteria.,What was the category of the criterion?,Criterion Type,Char,R/C,Check the appropriate box to indicate whether the criterion exception was related to the subject's inclusion or exclusion.,IECAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(IECAT),N/A,These categories have been defined in controlled terminology that must be used. Only records for criteria that are not met appear in the IE tabulation domain. IECAT must be populated. This criterion category may be collected on the CRF in a tick/checkbox format or it may be included as part of the criterion identification and mapped when the tabulation 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 applicant provides instructions to ensure the data is entered as intended.",IESCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column heading. This can be used to distinguish criteria for a sub-study or to categorize the criterion as a major or minor exception.",9
Findings,IE,N/A,N/A,10,IETESTCD,Inclusion/Exclusion Criterion Short Name,The unique identifier associated with the criterion that was the exception.,What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?,Exception Criterion Identifier,Char,HR,"If the subject was not eligible, record the identifying code for each criterion that was an exception.",IETESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This field is required to appear on the CRF, but may be null if there are no exceptions to the inclusion/exclusion criteria. The CRF should allow multiple exceptions to be recorded. Applicants 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. Applicants should use applicant-developed controlled terminology for IETESTCD.",10
Findings,IE,N/A,N/A,11,IETEST,Inclusion/Exclusion Criterion,Descriptive name of the inclusion or exclusion criterion that was the exception.,What was the description of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?,Exception Criterion Description,Char,O,"Record the description of the criterion, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",IETEST,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable IETESTCD may be determined from the value collected in IETEST. The tabulation variables IETESTCD and IETEST are required in the tabulation datasets.,N/A,N/A,Applicants 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 applicant provides instructions to ensure the data is entered as intended.",IEORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,(NY),"This is only a data collection field when a complete list of inclusion and exclusion criteria are included on the CRF with Yes/No response options. If the applicant collects only the criteria that are not fulfilled, then, when an inclusion criterion is not met, IEORRES is mapped to ""N"" and when an exclusion criterion is met, IEORRES is mapped to ""Y"".",12
Findings,LB,Central Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,LB,Central Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings,LB,Central Processing,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,LB,Central Processing,N/A,5,VISDAT,Visit Date,Date the 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 a tabulation variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable LBDTC in ISO 8601 format.",N/A,N/A,"The date the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the specimen collection date can be collected on the Laboratory CRF using the date (LBDAT) field.",5
Findings,LB,Central Processing,N/A,6,LBPERF,Lab Performed,"An indication of whether a planned lab measurement, series of lab measurements, tests, observations or was performed or specimens collected.",Was the sample collected?; Was the lab performed?,Lab Performed; Sample Collected,Char,HR,Indicate whether or not lab specimen was collected or measurement performed.,LBSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable LBSTAT. If the collection variable LBPERF = ""N"", the value of LBSTAT will be ""NOT DONE"". If LBPERF = ""Y"", LBSTAT should be null. A combination of tabulation variables ( e.g., LBCAT and LBSCAT, LBTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided.",(NY),N/A,"This may be implemented for an entire lab panel, or a specific lab test. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",6
Findings,LB,Central Processing,N/A,7,LBDAT,Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the lab specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date when specimen collection was done using this format (DD-MON-YYYY).,LBDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable LBDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. The tabulation LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",7
Findings,LB,Central Processing,N/A,8,LBTIM,Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the lab specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,LBDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 product is required for analysis or a specimen is collected over an extended time period.,8
Findings,LB,Central Processing,N/A,9,LBCAT,Category for Lab Test,A grouping of topic-variable values based on user-defined characteristics.,What was the name of the lab panel?,[Lab Panel Name]; NULL,Char,R/C,"Record the lab test category, if not pre-printed on the CRF.",LBCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category/subcategory (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).",9
Findings,LB,Central Processing,N/A,10,LBSCAT,Subcategory for Lab Test,A sub-division of the LBCAT values based on user-defined characteristics.,What was the name of the lab sub-panel?,[Lab Sub-Panel Name]; NULL,Char,R/C,"Record the lab test subcategory, if not pre-printed on the CRF.",LBSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology (e.g. electrolytes, liver function). This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.",10
Findings,LB,Central Processing,N/A,11,LBTPT,Lab Planned Time Point Name,"A text description of planned time point when measurements should be taken, as defined in the protocol.",What was the planned time point of the lab?,[Planned Time Point Name],Char,R/C,"Record the planned time point labels for the lab test, if not pre-printed on the CRF.",LBTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as tabulation variables LBTPTNUM, LBELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",11
Findings,LB,Central Processing,N/A,12,LBCOND,Lab Test Condition Met,"Indication whether the testing conditions defined in the protocol were met (e.g., low-fat diet).",Were the protocol-defined testing conditions met?,Test Condition Met,Char,R/C,Record whether protocol defined testing conditions were met.,SUPPLB.QVAL,This does not map directly to a tabulation 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".,(NY),N/A,This information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF. This may not be relevant for all tests.,12
Findings,LB,Central Processing,N/A,13,LBFAST,Lab Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,R/C,Record whether the subject was fasting prior to the test being performed.,LBFAST,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,13
Findings,LB,Central Processing,N/A,14,LBREFID,Lab Specimen ID,"An internal or external identifier (e.g., specimen identifier).",What was the (laboratory test) [reference identifier/accession number]?,(Laboratory) [Reference identifier/Accession Number],Char,R/C,Record the specimen or accession number assigned.,LBREFID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).",14
Findings,LB,Central Processing with CS,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",16
Findings,LB,Central Processing with CS,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",17
Findings,LB,Central Processing with CS,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",18
Findings,LB,Central Processing with CS,N/A,5,VISDAT,Visit Date,Date the 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 a tabulation variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable LBDTC in ISO 8601 format.",N/A,N/A,"The date of the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the collection date can be collected on the Laboratory CRF using the date (LBDAT) field",19
Findings,LB,Central Processing with CS,N/A,6,LBPERF,Lab Performed,"An indication of whether a planned lab measurement, series of lab measurements, test, or observation was performed or specimens collected.",Was the sample collected?; Was the lab performed?,Lab Performed; Sample Collected,Char,HR,Indicate whether or not lab specimen was collected or measurement performed.,LBSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable LBSTAT. If the collection variable LBPERF=""N"", the value of LBSTAT will be ""NOT DONE"". If LBPERF=""Y"", LBSTAT should be null. A combination of tabulation variables (e.g., LBCAT and LBSCAT, LBTPT ) is used to indicate that multiple tests were not done. In this situation, the tabulation variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided.",(NY),N/A,"This may be implemented for an entire lab panel, or a specific lab test. This general prompt question is used as a data management tool to verify that missing results are confirmed missing.",20
Findings,LB,Central Processing with CS,N/A,7,LBDAT,Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the lab specimen collection,Specimen Collection (Start) Date,Char,R/C,Record the (start) date when the specimen collection was done using this format (DD-MON-YYYY).,LBDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable LBDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of specimen collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required. The tabulation LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",21
Findings,LB,Central Processing with CS,N/A,8,LBTIM,Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the lab specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible).,LBDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 product is required for analysis or a specimen is collected over an extended time period.,22
Findings,LB,Central Processing with CS,N/A,9,LBCAT,Category for Lab Test,A grouping of topic-variable values based on user-defined characteristics.,What was the name of the lab panel?,[Lab Panel Name]; NULL,Char,R/C,"Record the lab test category, if not pre-printed on the CRF.",LBCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).",23
Findings,LB,Central Processing with CS,N/A,10,LBSCAT,Subcategory for Lab Test,A sub-division of the LBCAT values based on user-defined characteristics.,What was the name of the lab sub-panel?,[Lab Sub-Panel Name]; NULL,Char,R/C,"Record the lab test subcategory, if not pre-printed on the CRF.",LBSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology (e.g. electrolytes, liver function). This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.",24
Findings,LB,Central Processing with CS,N/A,11,LBTPT,Lab Planned Time Point Name,"A text description of planned time point when measurements should be taken, as defined in the protocol.",What was the planned time point of the lab?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for the lab test, if not pre-printed on the CRF.",LBTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as tabulation variables LBTPTNUM, LBELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",25
Findings,LB,Central Processing with CS,N/A,12,LBCOND,Lab Test Condition Met,"Indication of whether the testing conditions defined in the protocol were met (e.g., low-fat diet).",Were the protocol-defined testing conditions met?,Test Condition Met,Char,O,Record whether protocol-defined testing conditions were met.,SUPPLB.QVAL,This does not map directly to a tabulation 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".,(NY),N/A,"This information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF (e.g., ""Did subject meet diet requirements?""). This may not be relevant for all tests.",26
Findings,LB,Central Processing with CS,N/A,13,LBFAST,Lab Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,R/C,Record whether the subject was fasting prior to the test being performed.,LBFAST,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,27
Findings,LB,Central Processing with CS,N/A,14,LBTEST,Lab Test or Examination Name,Descriptive name of the lab test or examination used to obtain the measurement or finding. Any test normally performed by a clinical laboratory is considered a lab test.,What was the lab test name?,[Laboratory Test Name],Char,HR,"Record the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",LBTEST; LBTESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable LBTESTCD may be determined from the value collected in LBTEST. The tabulation variables LBTESTCD and LBTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(LBTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included as the column heading.",28
Findings,LB,Central Processing with CS,N/A,15,LBORRES,Lab Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the lab test?,(Result),Char,HR,Record the laboratory test result.,LBORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Optional if already provided from central lab.,29
Findings,LB,Central Processing with CS,N/A,16,LBORRESU,Lab Original Units,The unit of the result as originally received or collected.,What was the unit of the lab result?,Unit,Char,O,Record or select the original unit in which these data were collected.,LBORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,Optional if already provided from central lab or an applicant stores units separately.,30
Findings,LB,Central Processing with CS,N/A,17,LBCLSIG,Lab Clinical Significance,An indication whether lab test results were clinically significant.,Was this result clinically significant?,Clinically Significant,Char,HR,Record whether laboratory test results were clinically significant.,SUPPLB.QVAL,This does not map directly to a tabulation 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".,(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 tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to confirm that the appropriate data record is present in the electronic transfer. May be included for linking back to specimens (e.g., Specimen ID).",32
Findings,LB,Central Processing with CS,N/A,19,LBMETHOD,Lab Method of Test or Examination,Method of the test or examination.,What was the method used for the lab test or examination?,Method of Test or Examination,Char,O,Record the method of test or examination.,LBMETHOD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary.",33
Findings,LB,Local Processing,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",35
Findings,LB,Local Processing,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",36
Findings,LB,Local Processing,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",37
Findings,LB,Local Processing,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation, or specimen collection can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable LBDTC in ISO 8601 format.",N/A,N/A,"The date of the laboratory specimens were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the laboratory tests at that visit, or the collection date can be collected on the Laboratory CRF using the date (LBDAT) field.",38
Findings,LB,Local Processing,N/A,6,LBPERF,Lab Performed,"An indication of whether a planned lab measurement, series of lab measurements, test, or observation was performed or specimens collected.",Was the sample collected?; Was the lab performed?,Sample Collected; Lab Performed,Char,HR,Indicate whether or not lab specimen was collected or measurement performed.,LBSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable LBSTAT. If the collection variable LBPERF = ""N"", the value of LBSTAT will be ""NOT DONE"". If LBPERF = ""Y"", LBSTAT should be null. A combination of tabulation variables (e.g., LBCAT and LBSCAT, LBTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable LBTESTCD would be populated as LBALL and an appropriate test name (LBTEST) provided.",(NY),N/A,"This may be implemented for an entire panel, or on a specific test basis. General prompt question to be used as a data management tool to verify that missing results are confirmed missing.",39
Findings,LB,Local Processing,N/A,7,LBDAT,Specimen Collection Date,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (start) date of the lab specimen collection?,Specimen Collection (Start) Date,Char,R/C,Record the (start) date of specimen collection using this format (DD-MON-YYYY).,LBDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 tabulation LBDTC variable contains either a date/time when a specimen is collected at a point in time or the start date/time, when a specimen is collected over time.",40
Findings,LB,Local Processing,N/A,8,LBTIM,Specimen Collection Time,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (start) time of the lab specimen collection?,Specimen Collection (Start) Time,Char,R/C,Record the (start) time of collection (as complete as possible),LBDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 product is required for analysis or a specimen is collected over an extended time period.,41
Findings,LB,Local Processing,N/A,9,LBCAT,Category for Lab Test,A grouping of topic-variable values based on user-defined characteristics.,What was the name of the lab panel?,[Lab Panel Name]; NULL,Char,R/C,"Record the lab test category, if not pre-printed on the CRF.",LBCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBCAT and or LBSCAT should be included if lab status (NOT DONE) is collected for each lab category (e.g., HEMATOLOGY, CHEMISTRY, URINALYSIS).",42
Findings,LB,Local Processing,N/A,10,LBSCAT,Subcategory for Lab Test,A sub-division of the LBCAT values based on user defined characteristics.,What was the name of the lab sub-panel?,[Lab Sub-Panel Name]; NULL,Char,R/C,"Record the lab test subcategory, if not pre-printed on the CRF.",LBSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be applicant-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included as the column heading. Laboratory tests have commonly recognized categories and subcategories that should be used whenever appropriate. LBSCAT can only be used if there is an LBCAT, and it must be a subcategorization of LBCAT.",43
Findings,LB,Local Processing,N/A,11,LBTPT,Lab Planned Time Point Name,A text description of planned time point when measurements should be taken as defined in the protocol.,What was the planned time point of the lab?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for the lab test, if not pre-printed on the CRF.",LBTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. Tabulation time-point anchors LBTPTREF (text description) and LBRFTDTC (date/time) may be needed, as well as tabulation variables LBTPTNUM, LBELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included as the column heading.",44
Findings,LB,Local Processing,N/A,12,LBFAST,Lab Fasting Status,An indication that the subject has abstained from food/water for the specified amount of time.,Was the subject fasting?,Fasting,Char,R/C,Record whether the subject was fasting prior to the test being performed.,LBFAST,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,Results may be affected by whether the subject was fasting. This may not be relevant for all tests.,45
Findings,LB,Local Processing,N/A,13,LBCOND,Lab Test Condition Met,Indication of whether the testing conditions defined in the protocol were met,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 a tabulation 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".,(NY),N/A,This information is collected when the laboratory test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF This may not be relevant for all tests.,46
Findings,LB,Local Processing,N/A,14,LBSPCCND,Lab Specimen Condition,Description of the condition of the specimen.,What was the condition of the specimen?,Specimen Condition,Char,O,Record the condition of specimen.,LBSPCCND,Maps directly to the tabulation variable listed in the Tabulation Target column.,(SPECCOND),N/A,"May be collected using free or standardized text. Results may be affected by whether conditions for specimen were properly met. When local processing is used, applicants may not routinely collect specimen condition.",47
Findings,LB,Local Processing,N/A,15,LBTEST,Lab Test or Examination Name,Descriptive name of the lab test or examination used to obtain the measurement or finding. Any test normally performed by a clinical laboratory is considered a lab test.,What was the lab test name?,[Laboratory Test Name],Char,HR,"Record the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",LBTEST; LBTESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable LBTESTCD may be determined from the value collected in LBTEST. The tabulation variables LBTESTCD and LBTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(LBTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field that requires the site to enter text. If the form is laid out as a grid, then words such as ""Test"" can be included as the column heading.",48
Findings,LB,Local Processing,N/A,16,LBORRES,Lab Result or Finding in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the lab test?,(Result),Char,HR,Record the laboratory test result.,LBORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,49
Findings,LB,Local Processing,N/A,17,LBMETHOD,Lab Method of Test or Examination,Method of the test or examination.,What was the method used for the lab test or examination?,Method of [Test/Examination],Char,O,Record the method of test or examination.,LBMETHOD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary.",50
Findings,LB,Local Processing,N/A,18,LBORRESU,Lab Original Units,The unit of the result as originally received or collected.,What was the unit of the lab result?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",LBORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere. For some lab tests the units may not be applicable (e.g., urine color).",51
Findings,LB,Local Processing,N/A,19,LBCRESU,Lab Collected Non-Standard Unit,The unit of the result as originally received if it were collected as a non-standard unit.,What was the unit of the lab result?,Unit,Char,O,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",SUPPLB.QVAL,"This does not map directly to a tabulation variable. The collected, nonstandard unit(s) may be submitted in a supplemental qualifier dataset.",N/A,N/A,"The collected, nonstandard 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This is commonly used in oncology studies, but applicants may not collect these toxicity grades on CRFs. Terminology codeslists (TOXGRV3, TOXGRV4) are available for use.",53
Findings,LB,Local Processing,N/A,21,LBTOX,Lab Toxicity,"A description of toxicity quantified by LBTOXGR (e.g., NCI CTCAE Short Name).",What is the description of the toxicity?,Toxicity,Char,O,Record the description of the toxicity.,LBTOX,Maps directly to the tabulation variable listed in the Tabulation Target column.,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be determined from a site or lab specific set of normal ranges stored in a look-up table.,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,LBORNRLO and LBORNRHI should be populated only for continuous results; LBSTNRC should be populated only for non-continuous results. These data may be obtained from the lab or the electronic equipment. These data could be determined from a site or lab specific set of normal ranges stored in a look-up table.,56
Findings,LB,Local Processing,N/A,24,LBNRIND,Lab Reference Range Indicator,An indication or description of how the value compares to the normal range or reference range.,How [did/do] the reported values compare within the [reference/normal/expected] range?,Comparison to [Reference/Expected/Normal] Range,Char,R/C,"Record where the lab result fell with respect to the reference range (e.g. HIGH, LOW, ABNORMAL).",LBNRIND,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NRIND),N/A,"Reference ranges may be defined by LBORNRLO and LBORNRHI or other objective criteria. Typically for local processing, ""Reference Range Indicator"" may be derived or determined programmatically and is not collected on the CRF. Should not be used to indicate clinical significance.",57
Findings,LB,Local Processing,N/A,25,LBCLSIG,Lab Clinical Significance,An indication whether lab test results were clinically significant.,Was this result clinically significant?,Clinically Significant,Char,O,Record whether lab results were clinically significant.,SUPPLB.QVAL,This does not map directly to a tabulation 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".,(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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,Recommended to collect on the CRF if lab name was not collected at the site/study level or if multiple labs are used by a site.,59
Findings,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable PCDTC in ISO 8601 format.",N/A,N/A,"The date the PK samples were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the PK samples at that visit, or the collection date can be collected on the PK CRF using the date (PCDAT) field.",5
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,6,PCPERF,PK Sampling Performed,An indication of whether PK samples were collected.,Were PK samples collected?,Collected,Char,O,Check "No" if none of the samples were collected.,PCSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation 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 tabulation variables ( e.g., PCCAT and PCSCAT, PCTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable PCTESTCD would be populated as PCALL and an appropriate test name (PCTEST) provided.",(NY),N/A,"General prompt question to be used as a data management tool to verify that missing results are confirmed missing. This may be implemented at form level or sample level. These may be all samples of a particular type or all samples taken for some purpose and may need to be identified by the organization of the data on the form. Each sample collected could result in 1 or more tests performed, so there can be a one-to-one or one-to-many relationship between samples and tests/results.",6
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,7,PCSTAT,PK Sampling Completion Status,"This variable used to indicate that data are not available, by having the site record the value as ""Not Done"".",Record "Not Done" if the PK sample was not collected.,Not Done,Char,HR,Indicate if the specimen was not done.,PCSTAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ND),N/A,"A Not Done checkbox, which indicates the test was ""NOT DONE"". Typically, there would be 1 checkbox for each measurement. This field can be useful on individual sample collections to confirm that a blank result field is meant to be blank.",7
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,8,PCREASND,PK Sampling Reason Not Done,An explanation for why the data are not available.,What was the reason the PK sample was not collected?,Reason Not Collected,Char,O,Provide the reason why a PK sample was not collected.,PCREASND,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The reason the data are not available may be chosen from an applicant-defined list (e.g., broken equipment, subject refused) or entered as free text. When PCREASND is used, the tabulation variable PCSTAT should also be populated in the tabulation 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 a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable PCDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The date of collection may be determined from the date of visit (VISDAT); if so, a separate assessment date field is not required. The tabulation 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 a tabulation variable.,N/A,N/A,"When a series of specimens are collected on a single form, this field is tied to the collection date to allow for the flag to be used as a surrogate for the date field. Its selection means that the date of this specimen is the same as the date of the last specimen collected (in the series). This variable may be used when collecting PK data and re-entering dates is more cumbersome than selecting the checkbox.",10
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,11,PCTIM,PK Sample Collection Time,"The time of PK sample collection or start time for a specimen collected over a period of time (protocol-defined time-point range), represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the PK sample collection?,Collection Time,Char,HR,Record time of collection (as complete as possible).,PCDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable PCDTC in ISO 8601 format.",N/A,N/A,"A complete time is expected. The tabulation PCDTC variable contains either a date/time, when a specimen is collected at a point in time, or the start date/time, when a specimen is collected over time.",11
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,12,PCTPT,PK Sampling Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol.",What was the planned time point of the PK sample collection?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for the PK sample collection, if not pre-printed on the CRF. Note: Planned time points are often described as relative to exposure to study product.",PCTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors PCTPTREF (text description) and PCRFTDTC (date/time) may be needed, as well as tabulation variables PCTPTNUM, PCELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as ""Planned Time Point"" can be included in the column heading.",12
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,13,PCCOND,PK Sampling Test Condition Met,Indication of whether the testing conditions defined in the protocol were met.,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 a tabulation variable. This information could be represented in a SUPPPC dataset as the value of SUPPPC.QVAL where SUPPPC.QNAM ="PCCOND" and SUPP.PCLABEL= "Test Condition Met".,(NY),N/A,This information is collected when the test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF. This may not be relevant for all tests.,13
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,14,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 tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).",14
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,15,PCSPEC,PK Sampling Specimen Type,The type of specimen used for a PK sample.,What was the specimen (material) type?,[Specimen Type],Char,HR,"Record the specimen material type, if not pre-printed on the CRF.",PCSPEC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",15
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,16,PCTEST,PK Sampling Test Name,Descriptive name of the analyte or specimen characteristics used to obtain the PK measurement or finding.,What was the test name?,[Test Name],Char,O,"Record the name of the measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",PCTEST; PCTESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable PCTESTCD may be determined from the value collected in PCTEST. The tabulation variables PCTESTCD and PCTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,N/A,N/A,"Applicants typically collect tests related to the specimen characteristics on the CRF (e.g., Volume, Ph). Results for tests on an analyte (e.g., Concentration) would typically be populated when creating tabulation datasets. If the analyte test results are collected on the CRF, the test would be the analyte name. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",16
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,17,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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.",17
Findings,PC,PK Sample Collection at Fixed Time Points,N/A,18,PCORRESU,PK Sampling Original Units,The unit of the result as originally received or collected.,What was the unit of the result?,Unit,Char,O,"Select the original unit in which these data were collected, or record if not pre-printed on CRF.",PCORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field.",18
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",19
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",20
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",21
Findings,PC,PK Sample Collection over a Time Interval,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",22
Findings,PC,PK Sample Collection over a Time Interval,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started),What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, or observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation 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.",23
Findings,PC,PK Sample Collection over a Time Interval,N/A,6,PCPERF,PK Sampling Performed,An indication of whether PK samples were collected,Were PK samples collected?,Collected,Char,O,Indicate whether all of the PK samples in this group were collected.,PCSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation 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 tabulation variables (e.g., PCCAT and PCSCAT, PCTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable PCTESTCD would be populated as PCALL and an appropriate test name (PCTEST) provided.",(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.",24
Findings,PC,PK Sample Collection over a Time Interval,N/A,7,PCREASND,PK Sampling Reason Not Done,An explanation for why the data are not available,What was the reason the PK sample was not collected?,Reason Not Collected,Char,O,Provide the reason why a PK sample was not collected.,PCREASND,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The reason the data are not available may be chosen from an applicant-defined list (e.g., broken equipment, subject refused) or entered as free text. When PCREASND is used, the tabulation variable PCSTAT should also be populated in the tabulation dataset.",25
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 a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable PCDTC in ISO 8601 format.",N/A,N/A,"A complete date is expected. The tabulation 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.",26
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 a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 tabulation 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,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 a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation 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.",28
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 a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable PCENDTC in ISO 8601 format.",N/A,N/A,"A complete end time is expected. The tabulation variable PCENDTC variable contains the end date/time, when a specimen is collected over time. If there is no end date/time, the tabulation variable PCENDTC should be Null.",29
Findings,PC,PK Sample Collection over a Time Interval,N/A,12,PCTPT,PK Sampling Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol",What was the planned time point of the PK sample collection?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for the PK sample collection, if not pre-printed on the CRF. Note: Planned time points are often described as relative to exposure to study product.",PCTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors PCTPTREF (text description) and PCRFTDTC (date/time) may be needed, as well as tabulation variables PCTPTNUM, PCELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as ""Planned Time Point"" can be included in the column heading.",30
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 tabulation variable listed in the Tabulation Target column.,(NY),N/A,To be used when results may be affected by whether the subject was fasting.,31
Findings,PC,PK Sample Collection over a Time Interval,N/A,14,PCCOND,PK Sampling Test Condition Met,"Indication of whether the testing conditions defined in the protocol were met (e.g., low fat diet)",Were the protocol-defined testing conditions met?,Test Condition Met,Char,R/C,Record whether protocol-defined testing conditions were met.,SUPPPC.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPPC dataset as the value of SUPPPC.QVAL where SUPPPC.QNAM ="PCCOND" and SUPP.PCLABEL= "Test Condition Met".,(NY),N/A,This information is collected when the test results may be affected by whether conditions for testing were properly met. The specific testing conditions required should be pre-printed on the CRF. This may not be relevant for all tests.,32
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 tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"This can be used to reconcile CRF data. May be included for linking back to specimens (e.g., Specimen ID).",33
Findings,PC,PK Sample Collection over a Time Interval,N/A,16,PCSPEC,PK Sampling Specimen Type,The type of specimen used for a PK sample,What was the specimen (material) type?,Specimen Type,Char,HR,"Record the specimen material type, if not pre-printed on the CRF.",PCSPEC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(SPECTYPE),N/A,"The type of specimen used for a measure. Should be collected if not available elsewhere, or if required to differentiate multiple specimens.",34
Findings,PC,PK Sample Collection over a Time Interval,N/A,17,PCTEST,PK Sampling Test Name,Descriptive name of the analyte or specimen characteristics used to obtain the PK measurement or finding,What was the test name?,[Test Name],Char,O,"Record the name of the measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",PCTEST; PCTESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable PCTESTCD may be determined from the value collected in PCTEST. The tabulation variables PCTESTCD and PCTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,N/A,N/A,"Applicants 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 tabulation datasets are created. If analyte test results are collected on the CRF, the test would be the analyte name. It is recommended that test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",35
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,36
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,37
Findings,RE,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column .,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",1
Findings,RE,N/A,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,RE,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What is the subject identifier?,Subject,Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be provided to the site using a pre-populated list in the system. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings,RE,N/A,N/A,4,VISIT,Visit Name,"The name of an 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed in the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,RE,N/A,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable VSDTC in ISO 8601 format.",N/A,N/A,"The date the RE measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the RE CRF using the Respiratory Assessments (REDAT) field.",5
Findings,RE,N/A,N/A,6,REPERF,Respiratory Assessment Performed,"An indication of whether a planned measurement, test, observation or specimen was performed/collected.",Was a respiratory assessment performed?,Respiratory Assessment Performed,Char,HR,Indicate whether or not a respiratory assessment was done.,RESTAT,"This field does not map directly to an tabulation variable. May be used to populate a value into the tabulation variable RESTAT. If the collection variable REPERF=&quot;N&quot;, the value of the tabulation variable RESTAT is &quot;NOT DONE&quot;. If REPERF= &quot;Y&quot;, RESTAT is null. A combination of tabulation variables (e.g., RECAT and RESCAT, RETPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable RETESTCD would be populated with REALL and an appropriate test name (RETEST) provided.",(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 &quot;N&quot; and mapped to the -STAT variable in SDTM as &quot; NOT DONE&quot;.",6
Findings,RE,N/A,N/A,7,REDAT,Respiratory Assessment Date,"The date the respiratory measurement was performed, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the respiratory measurement was taken?,Date,Char,R/C,Record date of measurements using this format (DD-MON-YYYY).,REDTC,"This field does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable REDTC in ISO 8601 format.",N/A,N/A,"The date the RE measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the RE CRF using the Date of Collection (REDAT) field.",7
Findings,RE,N/A,N/A,8,RETIM,Respiratory Assessment Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the respiratory system measurement?,Time,Char,R/C,Record time of measurement (as complete as possible).,REDTC,"This field does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable REDTC in ISO 8601 format.",N/A,N/A,"A single collection time (e.g., RETIM) may be collected for all the measurements when they are performed at the same time. The time of each measurement can also be collected using a collection variable [RETESTCD]_RETIM.",8
Findings,RE,N/A,N/A,9,RETPT,RE Assessment Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol.",What is the planned time point for this respiratory assessment measurement?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for respiratory assessment, if not pre-printed on the CRF.",RETPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors RETPTREF (text description) and RERFTDTC (date/time) may be needed, as well as tabulation variables RETPTNUM, REELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then terms such as &quot;Planned Time Point&quot; can be included in the column heading.",9
Findings,RE,N/A,N/A,10,RETEST,Respiratory Test Name,Descriptive name of the test or examination used to obtain the measurement or finding.,What is the respiratory test name?,[Respiratory Test Name],Char,HR,"Record the name of the respiratory test, if not pre-printed on the CRF.",RETEST; RETESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable RETESTCD may be determined from the value collected in RETEST using the Controlled Terminology List RETESTCD.,(RETEST),N/A,"The test name will usually be pre-printed on the CRF, and not solicited as a question. If the form is laid out as a grid, then &quot;Test&quot; or &quot;Test Name&quot; can be included in the column heading. RETEST is most useful as the PROMPT on the field in which the RESULT for that test is collected.",10
Findings,RE,N/A,N/A,11,RECAT,Category for Respiratory Test,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the respiratory test?,[Respiratory Test Category]; NULL,Char,R/C,"Record the respiratory assessment category, if not pre-printed on the CRF.",RECAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. RESCAT can only be used if there is a RECAT. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as &quot;Category&quot; can be included in the column heading.",11
Findings,RE,N/A,N/A,12,RESCAT,Subcategory for Respiratory Test,A sub-division of the RECAT values based on user-defined characteristics.,What was the subcategory of the respiratory assessment?,[Respiratory Assessment Subcategory]; NULL,Char,O,"Record the respiratory assessment subcategory, if not pre-printed on the CRF.",RESCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as &quot;Subcategory&quot; can be included in the column heading. RESCAT can only be used if there is a RECAT, and it must be a subcategorization of RECAT.",12
Findings,RE,N/A,N/A,13,REORRES,RE Test Result in Original Units,Result of the measurement or finding as originally received or collected.,What was the result of the measurement?,[RETEST] Result,Char,HR,Record the respiratory test result.,REORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Both quantitative results and interpretive findings or summaries may be recorded here.,13
Findings,RE,N/A,N/A,14,REORRESU,Respiratory Test Original Unit,The unit of the result as originally received or collected.,What was the unit of the result?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",REORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,"Should be pre-printed on the CRF with the associated test when possible, rather than collected in a free-text field. Should be included if applicable and not available elsewhere.",14
Findings,RE,N/A,N/A,15,RERES,Respiratory Test Result or Finding,The result of the measurement or finding as originally received or collected.,Was the result (normal/abnormal/absent/present/ [applicant defined response])?,(Result),Char,O,Indicate the overall assessment for [RETEST].,REORRES,"This does not map directly to an tabulation variable. The mapping instructions depend on the implementation; for example: \n 1. RERES is used to collect Normal, Abnormal or similar type classifications (e.g., Absent/Present) with a description of the abnormal result using the collection field REDESC. For tabulation datasets, If the collection field RERES = &quot;NORMAL&quot;, populate the tabulation variables REORRES and RESTRESC with the value of the collection field RERES. If the collection field RERES is &quot;ABNORMAL&quot;, populate the tabulation variable REORRES with the collection field REDESC. If the reported findings in REDESC are coded using a dictionary, then the tabulation variable RESTRESC is populated with the dictionary preferred term and REMODIFY is populated with the modified text used for coding. If the reported findings in REDESC are not coded, then the tabulation variable RESTRESC is populated with the collection REDESC field. The tabulation variable RENRIND may be populated with &quot;NORMAL&quot; or &quot;ABNORMAL&quot; if appropriate. \n 2. Where RERES is used to collect standardized values (e.g. a codelist) on the CRF and the value of &quot;OTHER&quot; is included, the collection field RERESOTH can be used to collect free-text values for &quot;Specify Other&quot;. When using this field, the &quot;OTHER&quot; value recorded in the collect field RERES field is mapped to the tabulation variable RESTRESC and the value in the collection field RERESOTH is mapped to the tabulation variable REORRES.",N/A,N/A,"The collection field RERES is used when the collected results are not mapped directly to the tabulation variable REORRES and must be transformed. For example,RERES is used to collect standardized values on the CRF and the value of &quot;OTHER&quot; is included and &quot;Specify Other&quot; is collected.REORES is collected using Normal, Abnormal and a description of the abnormality is collected.",15
Findings,RE,N/A,N/A,16,REDESC,Description of Respiratory Test Finding,Text description of respiratory test findings.,What was the description of the (abnormality/observed finding/[Applicant-defined])?,(Abnormal) Findings,Char,O,Record all abnormal findings for the respiratory test in the space provided.,REORRES,"This does not map directly to an tabulation variable. May be used to populate a value into the tabulation variable REORRES. If RERES=&quot;Normal&quot;, populate REORRES with the value of RERES. If RERES=&quot;Abnormal&quot;, populate REORRES with the value of REDESC.",N/A,N/A,"RERES and REDESC are used when a question is asked to collect the finding result, with a follow-up question for a description of the finding.",16
Findings,RE,N/A,N/A,17,RERESOTH,Respiratory Test Result Other,A free-text result which provides further information about the original received or collected result.,"If other is selected, [explain/specify/provide more detail].",[Specify Other/Explain/Specify Details],Char,O,Provide more detail for the &quot;Other&quot; result.,REORRES,"When using this collection field, the &quot;OTHER&quot; value collected in the collection field RERES is mapped to the tabulation variable RESTRESC and the value in the collection field RERESOTH is mapped to the tabulation variable REORRES.",N/A,N/A,"In cases where RERES is used to collect standardized values on the CRF and the value of &quot;OTHER&quot; is included, the collection field RERESOTH can be used to collect free-text values for &quot;Specify Other&quot;.",17
Findings,RE,N/A,N/A,18,REORNRLO,RE Ref Range Lower Limit- Original Unit,The lower end of normal range or reference range for continuous results stored in REORRES.,What was the lower limit of the reference range?,Normal Range Lower Limit,Char,O,Record the lower limit of the reference range of the respiratory test.,REORNRLO,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,REORNRLO should be populated only for continuous findings. The tabulation variable RESTNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look-up table.,18
Findings,RE,N/A,N/A,19,REORNRHI,RE Ref Range Upper Limit- Original Unit,The upper end of normal range or reference range for continuous results stored in REORRES.,What was the upper limit of the reference range?,Normal Range Upper Limit,Char,O,Record the upper limit of the reference range of the respiratory test.,REORNRHI,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,REORNRHI should be populated only for continuous findings. The tabulation variable RESTNRC should be populated only for noncontinuous results. These data may be obtained from the lab or the electronic equipment. These data could be derived from a site or lab specific set of normal ranges stored in a look-up table.,19
Findings,RE,N/A,N/A,20,RENRIND,RE Reference Range Indicator,An indication or description about how the value compares to the normal range or reference range.,How do the reported values compare within the [reference/normal/expected] range?,Comparison to [Reference/Expected/Normal] Range,Char,O,Record where the test result fell with respect to the reference range.,RENRIND,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NRIND),N/A,"Reference ranges may be defined by REORNRLO, REORNRHI, RESTNRC or other objective criteria. Reference Range Indicator (e.g., Y, N; HIGH, LOW; NORMAL, ABNORMAL) may be included if not derived or determined programmatically after data collection. Should not be used to indicate clinical significance.",20
Findings,RE,N/A,N/A,21,RESTAT,Completion Status,"This variable is used to indicate that data are not available, by having the site recording the value as &quot;Not Done&quot;.",Indicate if the [RETEST] was not [answered/assessed/done/evaluated/performed].,Not Done,Char,O,Indicate if the respiratory assessment or measurement was not done.,RESTAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ND),N/A,Used only when the response value is collected as NOT DONE or NULL in lieu of or in addition to the collection REPERF field. Typically a checkbox which indicates the test was NOT DONE. This field can be useful when multiple questions are asked to confirm that a blank result field is meant to be blank.,21
Findings,RE,N/A,N/A,22,REREASND,Reason Not Done,An explanation for why the data are not available.,Was the was the reason that the respiratory (assessment/[RETEST]) was not [collected / answered / done / assessed / evaluated]?,Reason Not [Answered/Collected/Done/Evaluated/Assessed/Available],Char,O,Provide the reason the measurement or test was not done.,REREASND,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology may be used. The reason the data are not available may be chosen from an applicant-defined codelist (e.g., broken equipment, subject refused) or entered as free text. When REREASND is used, RESTAT should also be populated in the SDTM-based dataset.",22
Findings,RE,N/A,N/A,23,REPOS,Position of Subject During Observation,The position of the subject during a measurement or examination.,What was the position of the subject during the assessment?,Position,Char,O,Record the position of subject at time of test.,REPOS,Maps directly to the tabulation variable listed in the Tabulation Target column.,(POSITION),N/A,"Results may be affected by whether conditions for respiratory test, as specified in the protocol, were properly met. One common condition is the subject's position. If the protocol requires this type of information, then a collection variable [RETESTCD]_REPOS may be created for each RETESTCD and added to the CRF, if needed.",23
Findings,RE,N/A,N/A,24,RELOC,Location,Location used for the measurement.,What was the anatomical location where the measurement was taken?,Anatomical Location,Char,O,Record or select location on body where the measurement was performed.,RELOC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LOC),N/A,"Collected or pre-printed when the applicant needs to identify the specific anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.LAT, DIR, and PORTOT are used to further describe the anatomical location.",24
Findings,RE,N/A,N/A,25,RELAT,Laterality,"Qualifier for anatomical location, further detailing the side of the body.",What was the side of the anatomical location of the [measurement/test/examination])?,Side,Char,O,Record the side of the anatomical location of the respiratory test or measurement.,RELAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LAT),N/A,May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.,25
Findings,RE,N/A,N/A,26,REDIR,Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the respiratory test?,Directionality,Char,O,Record the directionality of the anatomical location of the respiratory test.,REDIR,Maps directly to the tabulation variable listed in the Tabulation Target column.,(DIR),N/A,May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.,26
Findings,RE,N/A,N/A,27,REMETHOD,Method of Respiratory Test,The method of the test or examination.,What was the method (used for the [measurement/test/examination])?,Method,Char,O,Record the method used for the respiratory test.,REMETHOD,Maps directly to the tabulation variable listed in the Tabulation Target column.,(METHOD),N/A,"This information may be collected when more than 1 method is possible, and collecting the method used is necessary.",27
Findings,RE,N/A,N/A,28,REEVAL,Respiratory Test Evaluator,The role of the person who provided the evaluation.,Who was the evaluator?,Evaluator,Char,O,Select the role of the person who provided the evaluation.,REEVAL,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EVAL),N/A,"Used only for results that are subjective (e.g., assigned by a person or a group). May be a pre-printed or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.",28
Findings,RE,N/A,N/A,29,REEVALID,Respiratory Test Evaluator Identifier,An identifier used to distinguish multiple evaluators with the same role recorded in REEVAL.,What is the identifier of the evaluator?,Evaluator Identifier,Char,O,Record the unique identifier assigned to the person making the evaluation.,REEVALID,Maps directly to the tabulation variable listed in the Tabulation Target column.,(MEDEVAL),N/A,Collect if multiple evaluators are used in the study (may be omitted if multiple evaluators are not used); values should follow controlled terminology.,29
Findings,RE,N/A,N/A,30,REACPTFL,Accepted Record Flag,"An indication that the evaluation is considered, by an independent assessor, to be the accepted or final evaluation.",Was this record considered to be the accepted evaluation?,Accepted Evaluation,Char,O,"Indicate whether or not the evaluation is considered, by an independent assessor, to be the accepted or final evaluation.",REACPTFL,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"Use where more than one assessor provides an evaluation of a result or response. Typically a checkbox with the value of &quot;Y&quot; or &quot;NULL&quot;, which indicates the evaluation was accepted.",30
Findings,RE,N/A,N/A,31,REREPNUM,Respiratory Test Repetition Number,"The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point, within a visit).",What was the repetition number within the time point for this measurement?,Repetition Number,Char,O,Record the repetition number of the measurement within the time point.,SUPPRE.QVAL,This does not map directly to an tabulation variable. This information could be represented in a SUPPRE dataset as the value of SUPPRE.QVAL where SUPPRE.QNAM = &quot;REREPNUM&quot; and SUPPRE.QLABEL= &quot;Repetition Number within Time Point&quot;.,N/A,N/A,The repetition number of the test/measurement within the time point may be pre-printed on the CRF.,31
Findings,RE,N/A,N/A,32,RECLSIG,Clinical Significance,An indication of whether the test results were clinically significant.,Was this result clinically significant?,Clinically Significant,Char,O,Record whether respiratory test results were clinically significant.,SUPPRE.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPRE dataset as the value of SUPPRE.QVAL when SUPPRE.QNAM = &quot;CLSIG&quot; and SUPPRE.QLABEL = &quot;Clinical Significance&quot;.,(NY),N/A,"Could apply to specific measurements or to overall interpretation, as required by the protocol.",32
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,SC,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper-This is typically recorded in the header of each CRF page. EDC- The subject identifiers may be provided to the site using a pre-populated list in the system. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings,SC,N/A,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,SC,N/A,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the collection VISDAT/VISTIM components and populating the tabulation variable SCDTC in ISO 8601 format.",N/A,N/A,"The date the subject characteristics were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the subject characteristics at that visit, or the collection date can be included on the SC CRF using the date (SCDAT) field.",5
Findings,SC,N/A,N/A,6,SCCAT,Category for Subject Characteristic,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the subject characteristics?,[Subject Characteristics Category ]; NULL,Char,O,"Record the subject characteristics category, if not pre-printed on the CRF.",SCCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",6
Findings,SC,N/A,N/A,7,SCSCAT,Subcategory for Subject Characteristic,A sub-division of the SCCAT values based on user-defined characteristics.,What was the subcategory of the subject characteristics?,[Subject Characteristics Subcategory]; NULL,Char,O,"Record the subject characteristics subcategory, if not pre-printed on the CRF.",SCSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. SCSCAT can only be used if there is an SCCAT, and it must be a subcategorization of SCCAT.",7
Findings,SC,N/A,N/A,8,SCPERF,SC Assessment Performed,An indication of whether any subject characteristics were collected.,Were subject characteristics collected?,Subject Characteristics Collected,Char,O,"Indicate if subject characteristics information was collected. If Yes, record the appropriate details.",SCSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable SCSTAT. If SCPERF=""N"", the value of SCSTAT will be ""NOT DONE"" . If SCPERF=""Y"", SCSTAT should be null. A combination of tabulation variables (e.g., SCCAT and SCSCAT, SCTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable SCTESTCD would be populated as SCALL and an appropriate test name (SCTEST) provided.",(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 Applicant-Defined Identifier,"An applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined collection identifier field.",[Applicant-defined question],[Applicant defined],Char,O,"If collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier.",SCSPID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Because SPID is a applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the applicant's data collection system.",9
Findings,SC,N/A,N/A,10,SCDAT,Subject Characteristic Collection Date,"The date of collection represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the date the subject characteristics were collected?,Date,Char,R/C,Record the date the subject characteristics were collected using the format (DD-MON-YYYY).,SCDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected collection DATE and TIME components and populate the tabulation variable SCDTC in ISO 8601 format.",N/A,N/A,"The date of collection can be determined from a collected date of the visit (VISDAT); in such cases, a date field is not required.",10
Findings,SC,N/A,N/A,11,SCTEST,Subject Characteristic,Descriptive name of the subject characteristic of interest.,What is the subject characteristics name?,[Subject Characteristic Test Name],Char,HR,"Record the name of the subject characteristics if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",SCTEST; SCTESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable SCTESTCD may be determined from the value collected in SCTEST. Use appropriate CDISC Controlled Terminology for the test and test code.,(SCTEST),N/A,"Required to identify which test the result is for. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column header.",11
Findings,SC,N/A,N/A,12,SCORRES,SC Result or Finding in Original Units,Result of the subject characteristic as originally received or collected.,What is the subject characteristic?,(Result),Char,HR,Record the subject characteristic.,SCORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,N/A,12
Findings,SC,N/A,Horizontal-Generic,1,STUDYID,Study Identifier,A unique identifier for a study,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",14
Findings,SC,N/A,Horizontal-Generic,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",15
Findings,SC,N/A,Horizontal-Generic,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This collection variable is typically collected in all collection domains. However, this collection variable is represented only in the tabulation DM domain.",16
Findings,SC,N/A,Horizontal-Generic,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the collection VISDAT/VISTIM components and populating the tabulation variable SCDTC in ISO 8601 format.",N/A,N/A,"The date the subject characteristics were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the subject characteristics at that visit, or the collection date can be included on the SC CRF using the date (SCDAT) field.",17
Findings,SC,N/A,Horizontal-Generic,6,[SCTESTCD]_SCCAT,Category for Subject Characteristic,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the subject characteristics??,[Subject Characteristics Category]; NULL,Char,O,"Record the subject characteristics category, if not pre-printed on the CRF.",SCCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading. This is an example of the types of collection variable names that can be used in a denormalized data structure.",18
Findings,SC,N/A,Horizontal-Generic,7,[SCTESTCD]_SCSCAT,Subcategory for Subject Characteristic,A sub-division of the SCCAT values based on user-defined characteristics.,What was the subcategory of the subject characteristics?,[Subject Characteristics Subcategory]; NULL,Char,O,"Record the subject characteristics subcategory, if not pre-printed on the CRF.",SCSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column header. SCSCAT can only be used if there is an SCCAT, and it must be a subcategorization of SCCAT. This is an example of the types of collection variable names that can be used in a denormalized data structure.",19
Findings,SC,N/A,Horizontal-Generic,8,[SCTESTCD]_SCPERF,SC Assessment Performed,An indication of whether any subject characteristics were collected.,Were subject characteristics collected for [SCTESTCD]?,[SCTEST] Collected,Char,O,"Indicate if subject characteristics information was collected. If Yes, include the appropriate details where indicated on the CRF.",SCSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation 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 tabulation variables (e.g., SCCAT and SCSCAT, SCTPT ) is used to indicate that multiple tests were not done. In this situation, the tabulation variable SCTESTCD would be assigned SCALL and an appropriate test name ( SCTEST) provided.",(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 tabulation datasets are created, the value of SCPERF would apply to all tests on the same record. Use the collection variable [SCTESTCD]_SCPERF when implemented on a specific test basis. This is an example of the types of collection variable names that can be used in a denormalized data structure.",20
Findings,SC,N/A,Horizontal-Generic,9,SCGRPID,Subject Characteristics Group ID,An applicant-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. Applicants may insert additional instructions to ensure each record has a unique group identifier.,SCGRPID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,It can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This group identifier ties together all the tests collected on this horizontal record. This field may be populated by the applicant'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,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,N/A,22
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Findings,VS,N/A,Horizontal-Generic,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all colelction domains. However, this collection variable is populated only in the tabulation DM domain.",3
Findings,VS,N/A,Horizontal-Generic,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",4
Findings,VS,N/A,Horizontal-Generic,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable VSDTC in ISO 8601 format.",N/A,N/A,"The date the VS measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the VS CRF using the date field (VSDAT).",5
Findings,VS,N/A,Horizontal-Generic,6,[VSTESTCD]_VSPERF,Vital Signs Performed,"An indication of whether a planned vital signs measurement, series of vital signs measurements, tests, or observations was performed.",Were [vital signs/[VSTEST] performed?,Vital Signs Performed ; [VSTEST] Performed,Char,O,"Indicate if the vital signs were collected. If Yes, include the appropriate details where indicated on the CRF.",VSSTAT,"This does not map directly to an tabulation variable. May be used to derive a value into the tabulation variable VSSTAT. If VSPERF=""N"", the value of VSSTAT will be ""NOT DONE"". If VSPERF=""Y"", VSSTAT should be null. A combination of tabulation variables (e.g., VSCAT and VSSCAT, VSTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable VSTESTCD would be populated as VSALL and an appropriate test name (VSTEST) provided.",(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 the tabulation dataset, the value of VSPERF would apply to all tests on the same record. Use the collection 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 tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 collection variable [VSTESTCD]_VSDAT. The date of the measurements may be determined from a collected date of visit; in such cases, a separate measurement date field is not required.",7
Findings,VS,N/A,Horizontal-Generic,8,[VSTESTCD]_VSTIM,Vital Signs Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the measurement(s)?,[VSTEST] Time,Char,R/C,Record time of measurement (as complete as possible).,VSDTC,"This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 collection variable [VSTESTCD]_VSTIM.",8
Findings,VS,N/A,Horizontal-Generic,9,VSCAT,Category for Vital Signs,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the vital signs?,[Vital Signs Category]; NULL,Char,O,"Record the vital signs category, if not pre-printed on the CRF.",VSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be from an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",9
Findings,VS,N/A,Horizontal-Generic,10,VSSCAT,Subcategory for Vital Signs,A sub-division of the VSCAT values based on user-defined characteristics.,What was the subcategory of the vital signs?,[Vital Signs Subcategory]; NULL,Char,O,"Record the vital signs subcategory, if not pre-printed on the CRF.",VSSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column header. VSSCAT can only be used if there is a VSCAT, and it must be a subcategorization of VSCAT.",10
Findings,VS,N/A,Horizontal-Generic,11,VSGRPID,Vital Signs Group ID,An applicant-defined identifier used to tie a block of related records in a single domain.,What is the vital signs group identifier?,Test Group ID,Char,O,Record unique group identifier. The applicant may insert additional instructions to ensure each record has a unique group identifier.,VSGRPID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,It can be beneficial to use an identifier in a data query to communicate clearly to the site the specific record in question. This group identifier ties together all the tests collected on the same horizontal record. This field may be populated by the applicant's data collection system.,11
Findings,VS,N/A,Horizontal-Generic,12,[VSTESTCD]_VSTPT,Vital Signs Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol.",What is the planned time point for this vital signs measurement?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for vital signs, if not pre-printed on the CRF.",VSTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors VSTPTREF (text description) and VSRFTDTC (date/time) may be needed, as well as tabulation variables VSTPTNUM, VSELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading. The planned time point of each measurement can also be collected using the collection variable [VSTESTCD]_VSTPT.",12
Findings,VS,N/A,Horizontal-Generic,13,[VSTESTCD]_VSSTAT,Vital Signs Completion Status,"This variable is used to indicate that data are not available, by having the site recording the value as ""Not Done"".",Indicate if the [VSTEST] measurement was not done.,Not Done,Char,O,Indicate if the vital signs measurement was not done.,VSSTAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ND),N/A,"A single ""Not Done"" can be collected once for all tests on the same horizontal record using VSSTAT. The value of VSSTAT applies to all measurements on that record when mapped to the tabulation dataset. If needed, for each test ""NOT DONE"" may be collected using the collection 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 tabulation variable listed in the Tabulation Target column. In addition to the tabulation variable VSORRES, create VSTESTCD from the collection variable name and determine the value of VSTEST from VSTESTCD. The 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 collection variable [TESTCD] e.g., SYSBP or [TESTCD]_VSORRES where TESTCD is the appropriate CT for the VS test code e.g., SYSBP_VSORRES. This is an examples of the types of collection variable names that can be used in a denormalized data structure.",14
Findings,VS,N/A,Horizontal-Generic,15,[VSTESTCD]_VSORRESU,VS Original Units,The unit of the result as originally received or collected.,What was the unit of the [VSTEST] measurement?,[VSTEST] Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",VSORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,"A single Unit field can be collected once for all measurements collected on the same horizontal record using VSUNIT. The value of VSUNIT applies to all measurements on that record when mapped to the tabulation dataset. If needed for each measurement, unit may be collected using the collection variable [VSTESTCD]_VSORRESU. Should be pre-printed on the CRF (or enterable from a picklist) with the associated test when possible, rather than collected as free-text.",15
Findings,VS,N/A,Horizontal-Generic,16,[VSTESTCD]_VSCLSIG,Vital Signs Clinical Significance,An indication of whether the vital signs results were clinically significant.,Was the [VSTEST] result clinically significant?,[VSTEST] Clinically Significant,Char,O,Record whether the vital sign result was clinically significant.,SUPPVS.QVAL,This does not map directly to an tabulation variable. This information could be represented in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM = "VSCLSIG" and SUPPVS.QLABEL="Clinically Significant".,(NY),N/A,"In horizontal data collection, a collection 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 tabulation variable listed in the Tabulation Target column.,(POSITION),(VSPOS),"Results may be affected by whether conditions for vital signs as specified in the protocol were properly met. One common condition is the subject's position. If the protocol requires this type of information, then a collection variable [VSTESTCD]_VSPOS may be created for each VSTESTCD and added to the CRF, if needed.",17
Findings,VS,N/A,Horizontal-Generic,18,[VSTESTCD]_VSLOC,Location of Vital Signs Measurement,"A description of the anatomical location of the subject, relevant to the collection of vital signs measurements.",What was the anatomical location where the [VSTEST] measurement was taken?,[VSTEST] Anatomical Location,Char,O,"Record or select location on body where measurement was performed, if not pre-printed on CRF.",VSLOC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LOC),N/A,"Collected or pre-printed on the CRF when the applicant needs to identify the specific anatomical location (e.g., ARM for blood pressure). Applicants may collect the data using a subset list of controlled terminology on the CRF. In horizontal data collection, a collection 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 tabulation variable listed in the Tabulation Target column.,(LAT),N/A,May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",21
Findings,VS,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What is the subject identifier?,Subject,Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be provided to the site using a pre-populated list in the system. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",22
Findings,VS,N/A,N/A,4,VISIT,Visit Name,"The name of an encounter that encompasses planned and unplanned study 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.",23
Findings,VS,N/A,N/A,5,VISDAT,Visit Date,Date the encounter occurred (or started).,What [is/was] the date of the visit?,(Visit) Date,Char,R/C,Record the [date/start date] of the visit using this format (DD-MON-YYYY).,N/A,"This field is not an tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable VSDTC in ISO 8601 format.",N/A,N/A,"The date the VS measurements were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit, or the collection date can be included on the VS CRF using the Vital Signs Date (VSDAT) field.",24
Findings,VS,N/A,N/A,6,VSPERF,Vital Signs Performed,"An indication of whether a planned vital signs measurement, series of vital signs measurements, tests, or observations was performed.",Were vital signs performed?,Vital Signs Performed,Char,O,"Indicate if vital signs were collected. If Yes, include the appropriate details where indicated on the CRF.",VSSTAT,"This does not map directly to a tabulation variable. May be used to derive a value into the tabulation variable VSSTAT. If VSPERF=""N"", the value of VSSTAT will be ""NOT DONE"". If VSPERF=""Y"", VSSTAT should be null. A combination of tabulation variables (e.g., VSCAT and VSSCAT, VSTPT) is used to indicate that multiple tests were not done. In this situation, the tabulation variable VSTESTCD would be populated as VSALL and an appropriate test name VSTEST provided.",(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 tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable VSDTC in ISO 8601 format.",N/A,N/A,"The date of measurement can be determined from a collected date of visit (VISDAT); in such cases, a separate measurement date field is not required.",26
Findings,VS,N/A,N/A,8,VSTIM,Vital Signs Time,"The time of measurement, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the time of the vital signs measurement?,Time,Char,R/C,Record time of measurement (as complete as possible).,VSDTC,"This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 Applicant-Defined Identifier,"An applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field.",[Applicant-defined question],[Applicant defined],Char,O,"If collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier.",VSSPID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is an applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the applicant's data collection system.",28
Findings,VS,N/A,N/A,10,VSTPT,Vital Signs Planned Time Point Name,"A text description of planned time points when measurements should be taken, as defined in the protocol.",What is the planned time point for this vital signs measurement?,[Planned Time Point Name],Char,R/C,"Record the planned time-point labels for vital signs, if not pre-printed on the CRF.",VSTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors VSTPTREF (text description) and VSRFTDTC (date/time) may be needed, as well as tabulation variables VSTPTNUM, VSELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",29
Findings,VS,N/A,N/A,11,VSCAT,Category for Vital Signs,A grouping of topic-variable values based on user-defined characteristics.,What was the category of the vital signs?,[Vital Signs Category]; NULL,Char,O,"Record the vital signs category, if not pre-printed on the CRF.",VSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be from a applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",30
Findings,VS,N/A,N/A,12,VSSCAT,Subcategory for Vital Signs,A sub-division of the VSCAT values based on user-defined characteristics.,What was the subcategory of the vital signs?,[Vital Signs Subcategory]; NULL,Char,O,"Record the vital signs subcategory, if not pre-printed on the CRF.",VSSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This is most commonly either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be a applicant-defined codelist. If the form is laid out as a grid, then words such as ""Subcategory"" can be included in the column heading. VSSCAT can only be used if there is a VSCAT, and it must be a subcategorization of VSCAT.",31
Findings,VS,N/A,N/A,13,VSREPNUM,Vital Signs Repetition Number,"The instance number of a test that is repeated within a given timeframe for the same test. The level of granularity can vary (e.g., within a time point, within a visit).",What was the repetition number within the time point for this measurement?,Repetition Number,Char,O,Record the repetition number of the measurement within the time point.,SUPPVS.QVAL,This does not map directly to an tabulation variable. This information could be represented in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM= "VSREPNUM" and SUPPVS.QLABEL= "Repetition Number within time point".,N/A,N/A,"The repetition number of the test/measurement within the time point may be pre-printed on the CRF (e.g., multiple measurements of blood pressure, multiple analyses of a sample).",32
Findings,VS,N/A,N/A,14,VSTEST,Vital Signs Test Name,Descriptive name of the test or examination used to obtain the measurement or finding.,What is the vital sign test name?,[Vital Signs Test Name],Char,HR,"Record the name of the vital sign test if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.",VSTEST; VSTESTCD,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable VSTESTCD may be determined from the value collected in VSTEST. Both VSTESTCD and VSTEST are required in the tabulation datasets. Use appropriate CDISC Controlled Terminology for the test and test code.,(VSTEST),N/A,"Required to identify which test the result is for. It is recommended that test names be pre-printed on the CRF rather than collected in a free-text field. If the form is laid out as a grid, then words such as ""Test"" can be included in the column heading.",33
Findings,VS,N/A,N/A,15,VSSTAT,Vital Signs Completion Status,"This variable is used to indicate that data are not available, by having the site recording the value as ""Not Done"".",Indicate if the vital signs measurement was not done,Not Done,Char,O,Indicate if the vital sign measurement was not done.,VSSTAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ND),N/A,"A Not Done checkbox, which indicates the test was NOT DONE. Typically, there would be 1 checkbox for each measurement. This field can be useful on individual VS tests to confirm that a blank result field is meant to be blank.",34
Findings,VS,N/A,N/A,16,VSORRES,VS Result or Finding in Original Units,Result of the vital signs measurement as originally received or collected.,What was the result of the measurement?,(Result),Char,HR,Record the vital sign result.,VSORRES,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,N/A,35
Findings,VS,N/A,N/A,17,VSORRESU,VS Original Units,The unit of the result as originally received or collected.,What was the unit of the measurement?,Unit,Char,R/C,"Record or select the original unit in which these data were collected, if not pre-printed on CRF.",VSORRESU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,"This should be pre-printed on the CRF (or enterable from a picklist) with the associated test when possible, rather than collected as free-text.",36
Findings,VS,N/A,N/A,18,VSCLSIG,Vital Signs Clinical Significance,An indication whether the vital sign result was clinically significant.,Was the result clinically significant?,Clinically Significant,Char,O,Record whether the vital sign result was clinically significant.,SUPPVS.QVAL,This does not map directly to an tabulation variable. This information could be represented in a SUPPVS dataset as the value of SUPPVS.QVAL where SUPPVS.QNAM = "VSCLSIG" and SUPPVS.QLABEL="Clinically Significant".,(NY),N/A,N/A,37
Findings,VS,N/A,N/A,19,VSLOC,Location of Vital Signs Measurement,"A description of the anatomical location of the subject, relevant to the collection of vital signs measurements.",What was the anatomical location where the measurement was taken?,Anatomical Location,Char,O,"Record or select location on body where measurement was performed, if not pre-printed on CRF.",VSLOC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LOC),N/A,"Collected or pre-printed when the applicant needs to identify the specific anatomical location (e.g., ARM for blood pressure). Applicants 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 tabulation variable listed in the Tabulation Target column.,(POSITION),(VSPOS),"Results may be affected by whether conditions for vital signs, as specified in the protocol, were properly met. One common condition is the subject's position.",39
Findings,VS,N/A,N/A,21,VSDIR,Vital Signs Directionality,"Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen.",What was the directionality of the anatomical location of the measurement?,Directionality,Char,O,Record the directionality.,VSDIR,Maps directly to the tabulation variable listed in the Tabulation Target column.,(DIR),N/A,May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants 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 tabulation variable listed in the Tabulation Target column.,(LAT),N/A,May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.,41
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included into the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: For single-site studies, this is typically pre-printed in the header of each CRF page. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,CM,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. \n EDC: The subject identifiers may be system-generated. \n This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",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/produuct]?,(Concomitant) [Medication/Treatment/Therapy/Product Category]; NULL,Char,O,"Record the (concomitant) [medication/treatment/therapy/product] category, if not pre-printed on the CRF.",CMCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included in the column heading.",4
Interventions,CM,N/A,N/A,5,CMSCAT,Subcategory for Medication,A sub-division of the CMCAT values based on user-defined characteristics.,What is the subcategory for the (concomitant) [medication/treatment/therapy/product]?,(Concomitant) [Medication/Treatment/Therapy/Product subcategory]; NULL,Char,O,"Record (concomitant) [medication/treatment/therapy/product] subcategory, if not pre-printed on the CRF.",CMSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer.,5
Interventions,CM,N/A,N/A,6,CMYN,Any Concomitant Medications Taken,An indication of whether any (concomitant) medications/treatments/therapies/products were taken/given.,Were/Was any (concomitant) [medication/treatment/therapy/product] taken?,Any (Concomitant) [Medication(s)/Treatment(s)/Therapy(ies)/Product(s)],Char,O,"Indicate if the subject took any (concomitant) [medication(s)/treatment(s)/therapy(ies)/product(s). If Yes, include the appropriate details where indicated on the CRF.",N/A,Does not map to a tabulation variable.,(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 Applicant-Defined Identifier,"A applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field.",[Applicant-defined question],[Applicant defined],Char,O,"If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.",CMSPID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is an applicant-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/productrecords with AEs and/or MH. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the applicant's data collection system.",7
Interventions,CM,N/A,N/A,8,CMTRT,"Reported Name of Drug, Med, or Therapy",Verbatim medication name of intervention,What was the (concomitant) [medication/treatment/therapy/product] name/term)?,(Concomitant) [Medication/Treatment/Therapy/Product],Char,HR,Record only 1 [medication/treatment/therapy/product] per line. Provide the full trade or proprietary name of the [medication/treatment/therapy/product]; otherwise the generic name may be recorded.,CMTRT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"In most cases, the verbatim intervention name will be coded to a standard dictionary (e.g., WHODrug) after data have been collected on the CRF. For the collection of verbatim intervention name, the recommendation is for sites to provide the full trade or proprietary name, which is more exact than the generic. The full trade name provides the base generic and the appropriate salt for that particular drug. In addition, for coding purposes, it helps with ATC selection (e.g., Tylenol with codeine #1 has a different ATC code than Tylenol with codeine #3). This field can be used for either prior or concomitant medication/treatments/products.",8
Interventions,CM,N/A,N/A,9,CMPRESP,CM Pre-Specified,An indication that a specific intervention or a group of interventions is pre-specified on a CRF.,N/A,N/A,Char,O,N/A,CMPRESP,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"For pre-specified interventions, this is a hidden field on a CRF defaulted to ""Y"", or added during the tabulation dataset creation. If a study collects both pre-specified and free-text interventions, the value of CMPRESP should be ""Y"" for all pre-specified interventions and null for interventions reported as free text.",9
Interventions,CM,N/A,N/A,10,CMOCCUR,CM Occurrence,An indication whether the prespecified medication/treatment/therapy/product (CMTRT) or the group of medications/treatments/therapies/products was administered when information about the occurrence of a specific intervention was solicited.,Did the subject take [prespecified (concomitant) medication/treatment/therapy/product/dose]?; Has the subject taken [prespecified (concomitant) medication/treatment/therapy/product/dose/]?,[Specific (Concomitant) [Medication/Treatment/Therapy/Product],Char,O,Indicate if [specific medication/treatment/product] was taken by checking Yes or No.,CMOCCUR,"Maps directly to the tabulation variable listed in the Tabulation Target column. If the question was not asked or answered, populate the tabulation variable CMSTAT with ""NOT DONE"".",(NY),N/A,CMOCCUR is used to report the occurrence of a pre-specified medication/treatment/product. CMOCCUR is not used for spontaneously free-text reported concomitant medication/treatments/products. The site should be able to indicate that the question was not asked or answered.,10
Interventions,CM,N/A,N/A,11,CMINGRD,Concomitant Meds Active Ingredients,Medication ingredients.,What were the active ingredients?,Active Ingredients,Char,O,"Prior to a subject's clinical visit, remind all subjects to bring all medications bottles, packs etc. they are taking with them to their clinical visit. Record all active ingredient(s) off the intervention label and separate each ingredient with a comma for the name of drug, medication, treatment or product 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 a tabulation variable.,N/A,N/A,"This may be collected in addition to the medication/treatment/product name. Collecting this provides more detailed information when coding to a medication dictionary like WHODrug Dictionary Enhanced Format C, which codes to the ingredient level for many trade-name medications. For example, depending on the country where it is manufactured, the active ingredients in the medication dolmen may be different: In Spain, acetylsalicylic acid, ascorbic acid, codeine phosphate; in Italy and Czech Republic, tenoxicam; in Estonia and Latvia, dexketoprofen trometamol.",11
Interventions,CM,N/A,N/A,12,CMINDC,CM Indication,"The condition, disease, symptom, or disorder that the concomitant (non-study) medication/treatment/therapy/product was used to address or investigate (e.g., why the medication/treatment/therapy/product was taken or administered).",For what indication was the (concomitant) [medication/treatment/therapy/product] 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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This is not the pharmacological/therapeutic classification of an agent (e.g., antibiotic, analgesic), but rather the reason for its administration to the subject. This additional information is collected on the CRF when applicants want to capture the reason(s) a subject took a medication/treatment/product. This information could be used as deemed appropriate for coding; analysis (e.g., in the classification of medications); reconciling medications/treatments/products 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/product.,What was the identifier for the adverse event(s) for which the (concomitant) [medication/treatment/therapy/product] was taken?,Adverse Event Identifier,Char,O,Record the identifier of the Adverse Event for which this (concomitant) [medication/treatment/therapy/product] was taken.,N/A,"This does not map directly to a tabulation variable. For tabulation datasets, may be used to create RELREC to link this record with a record in the AE domain.",N/A,N/A,The intent is to establish a link between the medication/treatment and the AE that was reported. CMAENO can be used to identify a relationship between records in CM dataset and records in the AE dataset.,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/product.,What was the identifier for the medical history event(s) for which the (concomitant) [medication/treatment/therapy/product] was taken?,Medical History Event Identifier,Char,O,Record the identifier of the medical history event for which this (concomitant) [medication/treatment/therapy/product] was taken.,N/A,"This does not map directly to a tabulation variable. For tabulation datasets, may be used to create RELREC to link this record with a record in the MH domain.",N/A,N/A,The intent is to establish a link between the medical history condition and the intervention taken for the condition. CMMHNO can be used to identify a relationship between records in the CM dataset and records in the MH dataset.,14
Interventions,CM,N/A,N/A,15,CMDOSE,CM Dose per Administration,"The dose of medication/treatment/product (e.g., --TRT ) given at one time, represented as a numeric value.",What was the individual dose (of the concomitant [medication/treatment/therapy/product] per administration)?,[Dose/Amount] (per administration),Num,O,"Record the dose of (concomitant) [medication/treatment/product] taken per administration (e.g., 200).",CMDOSE,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Used when the dose/amount taken/administered/consumed has only numeric entries. If non-numeric entries are possible, use the collection field CMDSTXT.",15
Interventions,CM,N/A,N/A,16,CMDSTXT,Concomitant Meds Dose Description,The dose of medication/treatment/product taken per administration.,What was the individual dose of the (concomitant) [medication/treatment/therapy/product]?,Dose,Char,O,"Record the dose of (concomitant) [medication/treatment/product] taken per administration (e.g., 200).",CMDOSTXT; CMDOSE,"This does not map directly to a tabulation variable. Numeric values map to CMDOSE in the tabulation dataset. Non-numeric values (e.g., ""200-400"") map to CMDOSTXT in the tabulation dataset.",N/A,N/A,"Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text, or ranges. The data collected in this text-format field should be separated or mapped to either tabulation 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/product]?,Total Daily Dose,Num,O,Record the total dose of (concomitant) [medication/treatment/therapy/product] taken daily.,CMDOSTOT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"For use when only total daily dose is collected on the CRF. For general medications/treatments/produts, it is not recommended to use Total Daily Dose. Instead, this can be calculated from other fields (e.g., Units, Dose, Frequency).",17
Interventions,CM,N/A,N/A,18,CMDOSU,CM Dose Units,"The unit associated with the concomitant medication/treatment/therapy/product taken (e.g., mg in ""2 mg 3 times per day"").",What is the unit (for the dose of concomitant [medication/treatment/therapy/product])?,(Dose) Unit,Char,R/C,"Record the dose unit of the dose of concomitant [medication/treatment/therapy/product] taken (e.g., mg.).",CMDOSU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),(CMDOSU),"When applicants 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/product]?,Dose Form,Char,O,"Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the concomitant [medication/treatment/therapy/product] taken.",CMDOSFRM,Maps directly to the tabulation variable listed in the Tabulation Target column.,(FRM),(CMDOSFRM),"Some drugs have multiple forms; this field may be needed to code the drug to an ATC level. However, in general, this level of detail should not be necessary except for medications/treatments/products 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/product]?,Frequency,Char,O,"Record how often the (concomitant) [medication/treatment/therapy/product] was taken (e.g., BID, PRN).",CMDOSFRQ,Maps directly to the tabulation variable listed in the Tabulation Target column.,(FREQ),(CMDOSFRQ),"The frequency of the concomitant medication/treatment/product. When collected, the recommendation is to collect dosing information in separate fields (e.g., CMDOSE, CMDOSEU, CMDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.",20
Interventions,CM,N/A,N/A,21,CMROUTE,CM Route of Administration,The route of administration of the concomitant medication/treatment/therapy/product.,What was the route of administration of the (concomitant) [medication/treatment/therapy/product]?,Route,Char,R/C,Provide the route of administration for the (concomitant) [medication/treatment/therapy/product].,CMROUTE,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ROUTE),(CMROUTE),"This additional information may be important to collect on the CRF when the applicant wants to capture a medication's/treatment's /product's route of administration, for purposes such as coding; also, the medication/treatment/product may have more than 1 route. Some companies may use route in coding medications/treatments/products, to be able to choose a precise preferred name and ATC code.",21
Interventions,CM,N/A,N/A,22,CMSTDAT,Concomitant Meds Start Date,"The start date is when the concomitant medication/treatment/therapy/product was first taken, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (concomitant) [medication/treatment/therapy/product/dose] start date?,Start Date,Char,R/C,"Record the date the concomitant [medication/treatment/product] was first taken using this format (DD-MON-YYYY). If the subject has been taking the concomitant [medication/treatment/product] for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Concomitant [medication/treatment/product] taken during the study are expected to have a complete start date. Prior concomitant [medication/treatment/product] that are exclusionary should have both a start and end date.",CMSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable CMSTDTC in ISO 8601 format.",N/A,N/A,"The assumption is that applicants should either have a Start Date or will indicate that the medication,therapy or product was started before, during, or after the study period. The preferred method is to collect a complete Start Date. Partial dates (e.g., providing year only) for medications/treatment/product 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/product was started, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the (concomitant) [medication/treatment/therapy/product/dose] start time?,Start Time,Char,R/C,Record the time (as complete as possible) that the concomitant [medication/treatment/product] was started.,CMSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable CMSTDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a concomitant medication/treatment/product was started only when a protocol or data collection scenarios supports it. Typically, a start time is not collected unless the subject is under the direct care of the site at the time a concomitant medication/treatment/product administered or the subject records the start time in a diary.",23
Interventions,CM,N/A,N/A,24,CMPRIOR,Prior Concomitant Meds,Indication the concomitant medication/treatment/therapy/product was given or taken prior to [CMSTTPT] or prior to the date in DM.RFSTDTC.,Was the (concomitant) [medication/treatment/therapy/product] given/taken prior to [CMSTTPT]?; Was the (concomitant) [medication/treatment/therapy/product] given/taken prior to study start?,Prior to [CMSTTPT]; Prior to Study,Char,O,Check if the concomitant [medication/treatment/therapy/product] was started before the study.,CMSTRF; CMSTRTPT,"This does not map directly to a tabulation variable. May be used to populate a value into a tabulation relative timing variable such as CMSTRF or CMSTRTPT. When populating CMSTRF, or CMSTRTPT, if the value of the collection 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 tabulation variable CMSTRF should be populated. When CMPRIOR is compared to another time point, the tabulation variables CMSTRTPT and CMSTTPT should be used. Note: CMSTRTPT must refer to the time-point anchor described in CMSTTPT.",(NY),N/A,Applicants may collect this information rather than start dates.,24
Interventions,CM,N/A,N/A,25,CMONGO,Ongoing Concomitant Meds,Indication the concomitant medication/treatment/therapy/product is ongoing when no end date is provided.,Was the (concomitant) [medication/treatment/therapy/product] 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/product] as ongoing if the subject has not stopped taking the concomitant [medication/treatment/therapy/product] at [the timepoint defined by the study]. If the concomitant medication/treatment/therapy/product is ongoing, the end date should be left blank",CMENRF; CMENRTPT,"This does not map directly to a tabulation variable. May be used to populate a value into a tabulation relative timing variable (e.g., CMENRF, CMENRTPT). When populating CMENRF, if the value of CMONGO is ""Y"", the values of ""DURING"", ""AFTER"", or ""DURING/AFTER"" may be used. When populating CMENRTPT, if the value of CMONGO is ""Y"", the value of ""ONGOING"" may be used. When CMONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the tabulation variable CMENRF should be populated. When CMONGO is used in conjunction with another time point, the tabulation variables CMENRTPT and CMENTPT should be used. Note: CMENRTPT must refer to a time-point anchor described in CMENTPT.",(NY),N/A,"This box should be checked to indicate that the concomitant medication/treatment/product has not stopped at the time of data collection. It is expected that every recorded medication/treatment/product should have either an end date or be checked as ongoing, but not both. However, in cases where ongoing concomitant medications/treatments/products are not permitted, it may not be necessary to include an Ongoing field in the CRF.",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/product, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the (concomitant) [medication/treatment/therapy/product/dose] end date?,End Date,Char,R/C,Record the date the concomitant [medication/treatment/product] was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant [medication/treatment/product] leave this field blank.,CMENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable CMENDTC in ISO 8601 format.",N/A,N/A,"The assumption is that applicants should either have an End Date or will indicate that the medication, therapy or product was ongoing at the time of collection or at the end of the study. However, in cases where the end date can be determined from dates collected elsewhere in the CRF it is not necessary to include an End Date field on the CRF. For example, if all concomitant medications/treatments/products 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/product, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the [medication/treatment/therapy/product/dose] end time?,End Time,Char,R/C,Record the time (as complete as possible) that the concomitant medication/treatment/product was stopped.,CMENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable CMENDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a concomitant medication,treatment, product was ended only when a protocol or data collection scenario requires it or the subject records the end time in a diary. Typically, an end time is not collected unless the subject is under the direct care of the site at the time a concomitant medication/treatment/product is stopped.",27
Interventions,CM,N/A,N/A,28,CMRSDISC,Reason for Intervention Discontinuation,The reason the Intervention was discontinued.,What was the reason the (concomitant) [medication/treatment/therapy/product/--TRT] was [discontinued/stopped/ended]?,Reason for discontinuation of concomitant medication/treatment/therapy/product.,Char,O,Record the reason the concomitant medication/treatment/product was stopped.,CMRSDISC,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although frequently used for prior meds, this can be used for any intervention at any timepoint. \n When the dosing is recorded over multiple successive records, this variable is applicable only for the (chronologically) last record for the intervention.",28
Interventions,CM,N/A,N/A,29,CMDECOD,Standardized Medication Name,"The dictionary or applicant-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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This field does not typically appear on the CRF. Applicants will populate this through the coding process. Equivalent to the generic drug name in published (e.g., WHODrug, SNOMED, ICD9) or applicant-defined dictionaries.",29
Interventions,CM,N/A,N/A,30,CMCLAS,CM Medication Class,The class for the intervention (often obtained from a coding dictionary).,N/A,N/A,Char,O,N/A,CMCLAS,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants 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,CMCLASCD,CM Medication Class Code,The assigned dictionary code for the class for the intervention.,N/A,N/A,Char,O,N/A,CMCLASCD,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This field does not typically appear on the CRF. Applicants will populate this through the coding process. This would generally be the class code used for analysis.,31
Interventions,CM,N/A,N/A,32,CMATC1,ATC Level 1 Description,Dictionary text description of the first level of hierarchy within the Anatomical Therapeutic Chemical (ATC) classification system; indicates the anatomical main group.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC1" and SUPPCM.QLABEL="ATC Level 1 Description".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,32
Interventions,CM,N/A,N/A,33,CMATC1CD,ATC Level 1 Code,Dictionary code denoting the first level of hierarchy within the ATC classification system; indicates the anatomical main group.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM ="MATC1CD" and SUPPCM.QLABEL="ATC Level 1 Code".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,33
Interventions,CM,N/A,N/A,34,CMATC2,ATC Level 2 Description,Dictionary text description for the second level of hierarchy within the ATC classification system; indicates the therapeutic main group.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC2" and SUPPCM.QLABEL="ATC Level 2 Description".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,34
Interventions,CM,N/A,N/A,35,CMATC2CD,ATC Level 2 Code,Dictionary code denoting the second level of hierarchy within the ATC classification system; indicates the therapeutic main group.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC2CD" and SUPPCM.QLABEL="ATC Level 2 Code".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,35
Interventions,CM,N/A,N/A,36,CMATC3,ATC Level 3 Description,Dictionary text description of the third level of hierarchy within the ATC classification system; indicates the therapeutic/pharmacological subgroup.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC3" and SUPPCM.QLABEL="ATC Level 3 Description".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,36
Interventions,CM,N/A,N/A,37,CMATC3CD,ATC Level 3 Code,Dictionary code denoting the third level of hierarchy within the ATC classification system; indicates the therapeutic/pharmacological subgroup.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC3CD" and SUPPCM.QLABEL="ATC Level 3 Code".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,37
Interventions,CM,N/A,N/A,38,CMATC4,ATC Level 4 Description,Dictionary text description of the fourth level of hierarchy within the ATC classification system; indicates the chemical/therapeutic/pharmacological subgroup.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC4" and SUPPCM.QLABEL="ATC Level 4 Description".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,38
Interventions,CM,N/A,N/A,39,CMATC4CD,ATC Level 4 Code,Dictionary code denoting the fourth level of hierarchy within the ATC classification system; indicates the chemical/therapeutic/pharmacological subgroup.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC4CD" and SUPPCM.QLABEL="ATC Level 4 Code".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,39
Interventions,CM,N/A,N/A,40,CMATC5,ATC Level 5 Description,Dictionary text description of the fifth level of hierarchy within the ATC classification system; indicates the chemical substance.,N/A,N/A,Char,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC5" and SUPPCM.QLABEL="ATC Level 5 Description".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,40
Interventions,CM,N/A,N/A,41,CMATC5CD,ATC Level 5 Code,Dictionary code denoting the fifth level of hierarchy within the ATC classification system; indicates the chemical substance.,N/A,N/A,Num,O,N/A,SUPPCM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC5CD" and SUPPCM.QLABEL="ATC Level 5 Code".,N/A,N/A,This field does not typically appear on the CRF. This is populated through the applicant's coding process.,41
Interventions,EC,N/A,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,EC,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. \n EDC: The subject identifiers may be system generated. \n This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",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/Applicant-defined phrase),Char,R/C,[protocol specific],EPOCH,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EPOCH),N/A,"If the same information is collected more than once in different periods/parts of a study (e.g., Disposition), EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as the title of the page.",4
Interventions,EC,N/A,N/A,5,ECYN,Any Study Product Taken,An indication of whether the subject used the study product.,Were any[study product/dose] taken?,Any Study Products,Char,O,"Indicate if the subject used any study products. If Yes, include the appropriate details where indicated.",N/A,Does not map to a tabulation variable.,(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 product name is pre-printed on the CRF. While these might be equivalent in a single-product study, there are differences in how they would be used in most trials. Therefore, it does not map into the tabulation variable ECOCCUR; ECOCCUR indicates whether the subject actually used study product. If actual data is available (ECYN =""Y""), ECOCCUR may be populated based on whether subject was actually used study product.",5
Interventions,EC,N/A,N/A,6,ECCAT,Category of Product,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the [study product/dose]?,[Study Product Category]; NULL,Char,O,"Record the study product category, if not pre-printed on the CRF.",ECCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as ""Category"" can be included as the column heading.",6
Interventions,EC,N/A,N/A,7,ECSCAT,Subcategory of Product,A sub-division of the ECCAT values based on user-defined characteristics.,What is the subcategory of the [study product/dose]?,[Study Product Subcategory]; NULL,Char,O,"Record the study product subcategory, if not pre-printed on the CRF.",ECSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. ECSCAT can only be used if there is an ECCAT and it must be a subcategorization of ECCAT.,7
Interventions,EC,N/A,N/A,8,ECTRT,Product,Name of the study product.,What was the [study product] name?,[Study Product Name],Char,R/C,Record the name of study product.,ECTRT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,ECTRT is the name of the product.,8
Interventions,EC,N/A,N/A,9,ECPRESP,Exposure as Collected Pre-Specified,An indication that a specific intervention or a group of interventions is pre-specified on a CRF.,N/A,N/A,Char,O,N/A,ECPRESP,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"For pre-specified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the tabulation dataset creation. If a study collects both pre-specified and free-text interventions, the value of ECPRESP should be ""Y"" for all pre-specified interventions and null for interventions reported as free text.",9
Interventions,EC,N/A,N/A,10,ECOCCUR,Exposure as Collected Occurrence,An indication whether the study product was used when information about the occurrence of a specific intervention was solicited.,Was [study product/dose] used?; Has the subject taken [study product/dose]?,[Study Product],Char,O,"Indicate if the subject used study product. If Yes, include the appropriate details where indicated.",ECOCCUR,Maps directly to the tabulation variable listed in the Tabulation Target column. Not applicable when ECMOOD is "Scheduled".,(NY),N/A,ECOCCUR is used to indicate whether the subject actually used study product. ECOCCUR should not be used to indicate that the question was not asked or answered.,10
Interventions,EC,N/A,N/A,11,ECREASOC,Exposure Reason for Occur Value,An explanation for why a scheduled study product administration did or did not occur.,What was the reason that the [study product/dose] was (not) used?,Reason (Not) Taken,Char,O,Indicate why the study product was or was not used.,SUPPEC.QVAL,This information could be represented in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM="ECREASOC" and SUPPEC.QLABEL ="Reason for Occur Value".,N/A,N/A,"The reason the study product was or was not taken may be chosen from an applicant-defined codelist or entered as free text. When --REASOC is used, --OCCUR must also be populated in the tabulation 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 product/dose] or used [study product/dose]?,Scheduled/Performed,Char,O,Indicate if this record has happened or is intended to happen.,ECMOOD,"Maps directly to the tabulation variable listed in the Tabulation Target column. When implemented, ECMOOD must be populated for all records.",(BRDGMOOD),N/A,"""SCHEDULED"" is for collected subject-level intended dose records. ""PERFORMED"" is for collected subject-level actual dose records. ""Planned"" or ""Scheduled"" can be pre-printed as the CRF name or section header, as applicable. If collecting both the scheduled and performed dosing in the same horizontal record, the applicant may choose to append ""_SCHEDULED"" to the ECDOSE/ECDOSTXT variable name to delineate the scheduled dose from the performed dose. The performed dose would just be collected with ECDOSE/ECDOSTXT and ECDOSU.",12
Interventions,EC,N/A,N/A,13,ECREFID,Exposure as Collected Reference ID,"An internal or external identifier (e.g., kit number, bottle label, vial identifier).",What is the [study product/dose] label identifier?,[Study Product] Label Identifier,Char,O,Record product label identifier.,ECREFID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This packaging identifier (e.g., kit number, bottle label, vial identifier) may be collected in different ways (e.g., affixing label onto CRF, scanning a bar code). For some study dosing regimens that require greater granularity for product identifiers, applicants 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 product/dose] used?,Lot Number,Char,R/C,Record the lot number that appears on the container holding the study product.,ECLOT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The lot number identifies the manufacturing batch of the study product. In open-label studies, the reference number on the study product container may represent an actual lot number and should be represented using ECLOT. This variable may be populated during the process of creating the tabulation datasets. Do not collect other identification variables in this field.",14
Interventions,EC,N/A,N/A,15,ECDOSFRM,Exposure as Collected Dose Form,The dosage form in which the ECTRT is physically presented.,What was the dose form of the [studyproduct /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 tabulation variable listed in the Tabulation Target column.,(FRM),(EXDOSFRM),This must be collected if it cannot be determined from other sources or if there are multiple options for the same study product.,15
Interventions,EC,N/A,N/A,16,ECSTDAT,Exposure as Collected Start Date,"The start date of study product, intended or actual, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the ([intended/planned/actual]) ([study product/dose]) (start) date?,(Start) Date,Char,HR,Record the start date of the study product administration using this format (DD-MON-YYYY).,ECSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable ECSTDTC in ISO 8601 format.",N/A,N/A,"Date when constant dosing interval of the study product 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.",16
Interventions,EC,N/A,N/A,17,ECSTTIM,Exposure as Collected Start Time,"The start time of study product, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the ([intended/planned/actual]) ([study product/dose]) (start) time?,(Start) Time,Char,R/C,Record the start time (as complete as possible) when administration of study product started.,ECSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable ECSTDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a product 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.",17
Interventions,EC,N/A,N/A,18,ECENDAT,Exposure as Collected End Date,"The end date of study product, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the ([intended/planned/actual]) ([study product/dose]) (end) date?,(End) Date,Char,R/C,Record the end date of the study product use using this format (DD-MON-YYYY).,ECENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable ECENDTC in ISO 8601 format.",N/A,N/A,"Date when study product period stopped. If start date and end date are not expected to be the same date, the collection of the end date is required. If the study design indicates that the start and end are on the same day, the collection of the end date is not required because it can be assigned to be equal to the start date.",18
Interventions,EC,N/A,N/A,19,ECENTIM,Exposure as Collected End Time,"The end time of study product use, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the ([intended/planned/actual]) ([study product/dose]) (end) time?,(End) Time,Char,R/C,"Record the time, (as complete as possible) when study product use stopped (e.g., for infusions this is the time when the infusion ended).",ECENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable ECENDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a medwas ended when a protocol or data collection scenarios requires it. For infusions, the end time of the infusion is typically needed.",19
Interventions,EC,N/A,N/A,20,ECDSTXT,Exposure as Collected Dose Description,The dose of study product taken (per administration).,What was the dose (per administration) (of [study product/dose])?,Dose,Char,R/C,Record the dose or amount of study product that was used 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 a tabulation 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 use of study product or per constant use interval recorded. Dose must be collected if it cannot be determined via other methods (e.g., from diary data, procuct 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.",20
Interventions,EC,N/A,N/A,21,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 tabulation variable listed in the Tabulation Target column.,(UNIT),(EXDOSU),"Unit of dose or amount taken per constant dosing interval recorded. Dose unit must be collected if it cannot be determined via other methods (e.g., from protocol, randomization data). The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. A CDASH Subset Controlled Terminology Codelist Name is available for dose and volume units. In blinded trials, the collected unit may be tablet, capsule, etc., since the actual unit is also blinded.",21
Interventions,EC,N/A,N/A,22,ECDOSFRQ,EC Dosing Frequency per Interval,The number of doses taken during a specific interval.,What was the frequency of [study product/dose] dosing?,Frequency,Char,R/C,"Record the frequency the study product was used for a defined period of time (e.g., BID, QID, TID).",ECDOSFRQ,Maps directly to the tabulation variable listed in the Tabulation Target column.,(FREQ),(EXDOSFRQ),"This may be collected if it cannot be determined from other sources or if there are multiple options. When possible, the options for dose/amount frequency are pre-printed on the CRF. When collected, the recommendation is to collect dosing information in separate fields (e.g., ECDOSE, ECDOSEU, ECDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.",22
Interventions,EC,N/A,N/A,23,ECROUTE,EC Route of Administration,The route of administration of the study product,What was the route of use (of the [study product/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 tabulation variable listed in the Tabulation Target column.,(ROUTE),(EXROUTE),"This may be collected if it cannot be determined via other methods (e.g., from protocol) or if there are multiple options.",23
Interventions,EC,N/A,N/A,24,ECDOSADJ,Dose Adjusted,An indication of whether the dose was adjusted.,Was the dose adjusted?,(Dose) Adjusted,Char,O,Select either Yes or No to indicate whether there was a change in dosing.,N/A,"When ECADJ is collected, does not map to a tabulation variable. When ECADJ is not collected, applicant may represent this variable in SUPPEC.",(NY),N/A,"Typically, the intent/purpose of collecting this field is to help with data cleaning and monitoring, as it provides a definitive response regarding any dose changes. It provides verification that the associated field on the CRF (ECADJ) was deliberately left blank. However, the applicant may collect whether the dose was adjusted, without collecting the reason for the change. When using ECMOOD, this field should not be used.",24
Interventions,EC,N/A,N/A,25,ECADJ,Reason for Dose Adjustment,Description of or explanation for why a dose of the study product was adjusted.,What was the reason the dose was adjusted?,Reason Adjusted,Char,O,"If there was a change in dosing, record the reason for change.",ECADJ,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Captures the reason the dose was changed or modified. The reason may be chosen from an applicant-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.",25
Interventions,EC,N/A,N/A,26,ECITRPYN,EC Exposure Interrupted,An indication of whether the exposure was interrupted.,Was the [(study) product/dose] interrupted?,[(Study) Product / Dose] Interrupted,Char,O,Record if there was an interruption in the study product use or dosing.,N/A,Does not map to a tabulation variable.,(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 collection field ECCINTD. In some situations, if the actual duration of the interruption is not collected or not derived, this information could be represented in a SUPPEC.QVAL dataset where SUPPEC.QNAM = ""ECITRPYN"" and SUPPEC.QLABEL = ""Exposure Interrupted"".",26
Interventions,EC,N/A,N/A,27,ECCINTD,EC Interruption Duration,The collected duration of the study product use interruption.,What was the duration of the interruption in product use?,(Interruption) Duration,Char,O,Record the duration of the interruption in project use.,SUPPEC.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM="ECITRPD" and SUPPEC.QLABEL= "Interruption Duration". Concatenate the collected interruption duration and the duration unit components and create ECITRPD using ISO 8601 Period format.,N/A,N/A,"This field is used to collect the duration of the interruption. In some situations, the duration of the interruption may not be collected but calculated from the product start and end times recorded elsewhere in the CRF.",27
Interventions,EC,N/A,N/A,28,ECCINTDU,EC Interruption Duration Units,The unit for the collected duration of the interruption in product use.,What was the interruption duration unit?,(Interruption Duration) Unit,Char,O,"Record the unit (e.g., MINUTES, HOURS, DAYS) for the duration of interruption in product use.",SUPPEC.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPEC dataset as the value of SUPPEC.QVAL where SUPPEC.QNAM = "ECITRPD" and SUPPEC.QLABEL= "Interruption Duration". Concatenate the interruption duration and the duration unit components and create ECITRPD using ISO 8601 Period format.,(UNIT),(EXINTPU),The unit should be collected as a qualifier to the number for duration.,28
Interventions,EC,N/A,N/A,29,ECLOC,EC Location of Dose Administration,A description of the anatomical location of administration.,What was the anatomical location of the ([study product/dose]) administration?,Anatomical Location,Char,O,"Record the body location where the study product was administered (e.g., SHOULDER, HIP, ARM).",ECLOC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LOC),N/A,"Collected or pre-printed when the applicant needs to identify the specific anatomical location where the study product was administered. LAT, DIR, PORTOT are used to further describe the anatomical location.",29
Interventions,EC,N/A,N/A,30,ECLAT,Exposure as Collected Laterality,"Qualifier for anatomical location, further detailing side of the body for the study product administration.",What was the side of the anatomical location of the ([study product/dose]) administration?,Side,Char,O,"Record the side of the body location where the study product was administered (e.g., Left, Right).",ECLAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LAT),N/A,Further details the laterality of the location where the study product was administered. This may be pre-printed or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.,30
Interventions,EC,N/A,N/A,31,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 product/dose]) administration?,Directionality,Char,O,"Record the directionality of the body location where the study product was administered (e.g., Anterior, Lower, Proximal, Upper).",ECDIR,Maps directly to the tabulation variable listed in the Tabulation Target column.,(DIR),N/A,May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.,31
Interventions,EC,N/A,N/A,32,ECVAMT,EC Vehicle Amount,The amount of the prepared product (product + vehicle) used.,What was the total amount (Product + Vehicle) (of [study product/dose]) used?,Total Amount (Product + Vehicle),Num,O,Record the total amount (product +vehicle) that was administered/given to the subject.,ECVAMT,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable ECTRTV may also be populated during the process of creating the tabulation datasets.,N/A,N/A,Administration amount that was used by 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.,32
Interventions,EC,N/A,N/A,33,ECVAMTU,EC Vehicle Amount Units,The unit of measurement for the prepared product (product + vehicle).,What was the unit for the amount (of [study product/dose] used)?,Unit,Char,O,"Record the unit of total amount (product +vehicle) used by the subject (e.g., mL).",ECVAMTU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,Unit of the used amount,33
Interventions,EC,N/A,N/A,34,ECTPT,EC Planned Time Point Name,"A text description of the planned time point when measurements should be taken, as defined in the protocol.",What was the planned time point for [product study /dose] use?,[Planned Time Point Name],Char,R/C,Record the planned time point of study product use if not pre-printed on the CRF.,ECTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors ECTPTREF (text description) and ECRFTDTC (date/time) may be needed, as well as tabulation variables ECTPTNUM, ECELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Planned Time Point can be included as the column heading.",34
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,EX,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",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/Applicant-defined phrase),Char,R/C,[protocol specific],EPOCH,Maps directly to the tabulation variable listed in the Tabulation Target column.,(EPOCH),N/A,"If the same information is collected more than once in different periods/parts of a study (e.g., Disposition), EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as the title of the page.",4
Interventions,EX,N/A,N/A,5,EXYN,Any Study Product Taken,An indication of whether the subject used study product.,Were any [study product/dose] taken?,Any Study Products,Char,O,"Indicate if the subject used any study products. If Yes, include the appropriate details where indicated.",N/A,Does not map to a tabulation variable.,(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 Product,A grouping of topic-variable values based on user-defined characteristics.,What is the category of the [study product/dose] ?,[Study Product Category]; NULL,Char,O,"Record the study product category, if not pre-printed on the CRF.",EXCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-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 Product,A sub-division of the EXCAT values based on user-defined characteristics.,What is the subcategory of the [study product/dose] ?,[Study Product Subcategory]; NULL,Char,O,"Record the study product subcategory, if not pre-printed on the CRF.",EXSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. EXSCAT can only be used if there is an EXCAT and it must be a subcategorization of EXCAT.,7
Interventions,EX,N/A,N/A,8,EXTRT,Name of Product,Name of the study product given for the observation.,What was the study product name?,[Study Product Name],Char,R/C,Record the name of study product.,EXTRT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,EXTRT captures the name of the study product. This is typically collected for open label studies and populated for blinded studies during the tabulation dataset creation.,8
Interventions,EX,N/A,N/A,9,EXREFID,Exposure Reference ID,An internal or external identifier.,What is the [study product/dose] label identifier?,Product Label Identifier,Char,R/C,Record product label identifier.,EXREFID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,This packaging identifier may be collected in different ways.,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 product/dose] used?,Lot Number,Char,R/C,Record the lot number that appears on the container holding the study product.,EXLOT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The lot number identifies the manufacturing batch of the study product. In open-label studies, the reference number on the study product container may represent an actual lot number and is represented using EXLOT. This variable may be populated during the process of creating the tabulation datasets. Do not collect other identification variables in this field.",10
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 product/dose]?,Dose Form,Char,R/C,Record the dose form or enter the appropriate code from the code list.,EXDOSFRM,Maps directly to the tabulation variable listed in the Tabulation Target column.,(FRM),(EXDOSFRM),This must be collected if it cannot be determined from other sources or if there are multiple options.,11
Interventions,EX,N/A,N/A,13,EXSTDAT,Exposure Start Date,"The start date of study product, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the ([intended/planned/actual]) ([study product/dose]) (start) date?,(Start) Date,Char,HR,Record the start date of the study product administration using this format (DD-MON-YYYY).,EXSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable EXSTDTC in ISO 8601 format.",N/A,N/A,"Date when the constant interval of the study product use started, or single use occurred. When collecting the date for an individual dose, the word ""start"" may be omitted from the question text and prompt.",12
Interventions,EX,N/A,N/A,14,EXSTTIM,Exposure Start Time,"The start time of the study product use, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the ([intended/planned/actual]) ([study product/dose]) (start) time?,(Start) Time,Char,R/C,Record the start time (as complete as possible) when administration of study product started.,EXSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable EXSTDTC in ISO 8601 format.",N/A,N/A,Recommend collecting the time a product was started only when a protocol or data collection scenario requires it.,13
Interventions,EX,N/A,N/A,15,EXENDAT,Exposure End Date,"The end date of study product use represented in an unambiguous date format (e.g., DD-MON-YYYY).",What was the ([intended/planned/actual]) ([study product/dose]) (end) date?,(End) Date,Char,R/C,Record the end date or last date of administration of study product using this format (DD-MON-YYYY).,EXENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable EXENDTC in ISO 8601 format.",N/A,N/A,"If start date and end date are not expected to be on the same date, the end date is required. If the study design indicates that the start and end date are on the same day, the end date is not required because it can be assigned to be equal to the start date.",14
Interventions,EX,N/A,N/A,16,EXENTIM,Exposure End Time,"The end time of study product use, represented in an unambiguous time format (e.g., hh:mm:ss).",What was the ([intended/planned/actual]) ([study product/dose]) (end) time?,(End) Time,Char,R/C,"Record the time, (as complete as possible) when study product administration stopped.",EXENDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable EXENDTC in ISO 8601 format.",N/A,N/A,"Recommend collecting the time a product was ended when a protocol or data collection scenario requires it. For infusions, the end time of the infusion is typically needed.",15
Interventions,EX,N/A,N/A,17,EXDSTXT,Exposure Dose Description,Dose (per administration).,What was the dose [per administration] (of [study product/dose]) ?,Dose,Char,R/C,Record the dose or amount of study product that was used 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 a tabulation variable. Numeric values map to tabulation variable EXDOSE. Non-numeric values (e.g., 200-400) map to tabulation variable EXDOSTXT.",N/A,N/A,"Dose or amount taken for single administration of study product or per constant dosing interval recorded. Dose must be collected if it cannot be determined via other methods (e.g., from diary data, product accountability data, protocol). The data collected in this dose text-format field should be mapped to either tabulation variable EXDOSE (if numeric) or EXDOSTXT (if text).",16
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 tabulation variable listed in the Tabulation Target column.,(UNIT),N/A,"Unit of dose or amount taken per constant dosing interval recorded. Dose unit must be collected if it cannot be determined via other methods (e.g., from protocol). The unit should be pre-printed on the CRF or a field provided on the CRF to capture it. A CDASH Subset Controlled Terminology Codelist Name is available for general dose and volume units.",17
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 product/dose] dosing?,Frequency,Char,R/C,Record the frequency the study product was administered for a defined period of time.,EXDOSFRQ,Maps directly to the tabulation variable listed in the Tabulation Target column.,(FREQ),N/A,"This may be collected if it cannot be determined from other sources or if there are multiple options. When possible, the options for dose/amount frequency are pre-printed on the CRF. When collected, the recommendation is to collect dosing information in separate fields (e.g., ECDOSE, ECDOSEU, ECDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.",18
Interventions,EX,N/A,N/A,20,EXROUTE,Exposure Route of Administration,The route of administration of the study product.,What was the route of administration (of the [study product/dose] )?,Route,Char,R/C,"Record the route of administration (e.g., ORAL) or enter the appropriate code from the code list.",EXROUTE,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ROUTE),(EXROUTE),"This may be collected if it cannot be determined via other methods (e.g., from protocol) or if there are multiple options.",19
Interventions,EX,N/A,N/A,22,EXDOSADJ,Dose Adjusted,An indication of whether the dose was adjusted.,Was the dose adjusted?,(Dose) Adjusted,Char,O,Select either Yes or No to indicate whether there was a change in dosing.,N/A,"When EXADJ is collected, does not map to a tabulation variable. When EXADJ is not collected, the applicant may represent 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 applicant may collect whether the dose was adjusted, without collecting the reason for the change.",20
Interventions,EX,N/A,N/A,23,EXADJ,Reason for Dose Adjustment,Description of or explanation for why a dose of the study product was adjusted.,What was the reason the dose was adjusted (from planned)?,Reason Adjusted,Char,O,"If there was a change in dosing, record the reason for change.",EXADJ,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Captures the reason the dose was changed or modified. The reason may be chosen from an applicant-defined list (e.g., adverse event) or entered as free text. May be used for variations from protocol-specified doses or changes from expected doses.",21
Interventions,EX,N/A,N/A,24,EXITRPYN,EX Exposure Interrupted,An indication of whether the exposure was interrupted.,Was the [(study) product/dose] interrupted?,[(Study) Product / Dose] Interrupted,Char,O,Record if there was an interruption in the study product use or dosing.,N/A,Does not map to a tabulation variable.,(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 collection field EXCINTD. In some situations, if the actual duration of the interruption is not collected, or not derived, this information could be represented in a SUPPEX.QVAL dataset where SUPPEX.QNAM = ""EXITRPYN"" and SUPPEX.QLABEL = ""Exposure Interrupted"".",22
Interventions,EX,N/A,N/A,25,EXCINTD,Exposure Interruption Duration,The collected duration of the product interruption.,"If the dose was interrupted, how long was the interruption?",(Interruption) Duration,Char,O,Record the duration of product use interruption.,SUPPEX.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM="EXITRPD" and SUPPEX.QLABEL= "Interruption Duration". Concatenate the collected product interruption duration and the duration unit components and create EXITRPD using ISO 8601 Period format.,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.",23
Interventions,EX,N/A,N/A,26,EXCINTDU,Exposure Interruption Duration Units,The unit for the collected duration of product 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 product use interruption.",SUPPEX.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPEX dataset as the value of SUPPEX.QVAL where SUPPEX.QNAM = "EXITRPD" and SUPPEX.QLABEL= "Interruption Duration". Concatenate the collected interruption duration and the duration unit components and create EXITRPD using ISO 8601 Period format.,(UNIT),(EXINTPU),The unit should be collected and converted into ISO 8601 period format.,24
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 product/dose] ) administration?,Anatomical Location,Char,O,"Record the body location where the study product was administered (e.g., SHOULDER, HIP, ARM).",EXLOC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LOC),N/A,"Collected or pre-printed when the applicant needs to identify the specific anatomical location where the study product was administered. LAT, DIR, PORTOT are used to further describe the anatomical location.",25
Interventions,EX,N/A,N/A,28,EXVAMT,Exposure Vehicle Amount,The amount of the prepared product (product + vehicle) administered or given.,What was the total amount (product + vehicle)(of [study product/dose] ) administered?,Total Amount,Num,O,Record the total amount (product +vehicle) that was administered/given to the subject.,EXVAMT,Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable ECTRTV may also be populated during the process of creating the tabulation 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.,26
Interventions,EX,N/A,N/A,29,EXVAMTU,Exposure Vehicle Amount Units,The unit of measure for the prepared product (product + vehicle).,What was the unit for the amount (of [study product/dose] ) administered?,Unit,Char,O,"Record the unit of total amount (product +vehicle) administered/given to the subject (e.g., mL).",EXVAMTU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(UNIT),(EXVOLTU),Unit of the administration amount. A CDASH Subset Controlled Terminology Codelist Name is available for dose and volume units.,27
Interventions,EX,N/A,N/A,32,EXTPT,Exposure Planned Time Point Name,"A text description of the planned time point when measurements should be taken, as defined in the protocol.",What was the planned time point for [study product/dose] ?,[Planned Time Point Name],Char,R/C,Record the planned time point of study product administration if not pre-printed on the CRF.,EXTPT,"Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation time-point anchors EXTPTREF (text description) and EXRFTDTC (date/time) may be needed, as well as tabulation variables EXTPTNUM, EXELTM.",N/A,N/A,"Planned time points are needed to differentiate multiple sequential assessments. It is recommended that time points should be pre-printed on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as ""Planned Time Point"" can be included in the column heading.",28
Interventions,EX,N/A,N/A,34,EXLAT,Exposure Laterality,"Qualifier for anatomical location, further detailing side of the body for the study product administration.",What was the side of the anatomical location of the ([study product/dose]) administration?,Side,Char,O,"Record the side of the body location where the study product was administered (e.g., Left, Right).",EXLAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,(LAT),N/A,Further details the laterality of the location where the study product was administered. This may be pre-printed or collected. Applicants may collect the data using a subset list of controlled terminology on the CRF.,29
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 product/dose]) administration?,Directionality,Char,O,"Record the directionality of the body location where the study product was administered (e.g., Anterior, Lower, Proximal, Upper).",EXDIR,Maps directly to the tabulation variable listed in the Tabulation Target column.,(DIR),N/A,May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF.,30
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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Interventions,SU,N/A,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.",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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicants may require different types of substance-use data (e.g., illicit drug use, cigarettes); the value for category may be pre-printed on the CRF as a label for the prompt for Substance Use. If a more detailed type of substance appears on the CRF (e.g., CIGARETTES, CIGARS rather than TOBACCO), SUCAT should be TOBACCO and SUTRT should be CIGARETTES.",4
Interventions,SU,N/A,N/A,5,SUCAT,Category for Substance Use,A grouping of topic-variable values based on user-defined characteristics.,What is/was the category of the substance (used)?,[Substance (Used) Category]; NULL,Char,R/C,"Record the Substance Used category, if not pre-printed on the CRF.",SUCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Applicant-defined controlled terminology (e.g., TOBACCO, ALCOHOL, CAFFEINE). Applicants may require different types of substance-use data (e.g., illicit drug use, cigarettes); the value for category may be pre-printed on the CRF. If a more detailed type of substance appears on the CRF (e.g., CIGARETTES, CIGARS, rather than TOBACCO), SUCAT is TOBACCO and SUTRT is CIGARETTES. If the applicant does not specify a type of tobacco on the CRF, SUTRT is TOBACCO. If SUCAT is not collected (e.g., it is evident from the protocol design), it could be populated during the tabulation dataset creation process.",5
Interventions,SU,N/A,N/A,6,SUSCAT,Subcategory for Substance Use,A sub-division of the SUCAT values based on user-defined characteristics.,What was the subcategory of the substance (used)?,[Substance (Used) Subcategory]; NULL,Char,O,"Record the Substance Use subcategory, if not pre-printed on the CRF.",SUSCAT,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,Applicant-defined controlled terminology. The value for subcategory may be pre-printed on the CRF or hidden. SUSCAT can only be used if there is a SUCAT and it must be a subcategorization of SUCAT.,6
Interventions,SU,N/A,N/A,7,SUPRESP,SU Prespecified,An indication that a specific intervention or a group of interventions is prespecified on a CRF.,N/A,N/A,Char,O,N/A,SUPRESP,Maps directly to the tabulation variable listed in the Tabulation Target column.,(NY),N/A,"For pre-specified interventions, a hidden field on a CRF defaulted to ""Y"", or added during the tabulation dataset creation. If a study collects both pre-specified and free-text interventions, the value of SUPRESP should be ""Y"" for all prespecified interventions and null for interventions reported as free text.",7
Interventions,SU,N/A,N/A,8,SUYN,Any Substance Used,An indication of whether any data was collected for the intervention topic.,Were any [applicant-phrase/substance name/recreational drugs] used?,Any [Substance Name (Used)],Char,O,Indicate if the subject had used any (applicant-defined phrase/recreational drugs/alcohol/substance name).,N/A,Does not map to a tabulation variable.,(NY),N/A,General prompt question to aid in monitoring and data cleaning. This provides verification that all other fields on the CRF were deliberately left blank. This is a field that can be used on any Interventions CRF to indicate whether there is data to record.,8
Interventions,SU,N/A,N/A,9,SUNCF,Never Current Former Usage,Indication the pre-specified substance was used.,Has the subject ever [used/consumed] [SUTRT/SUCAT]?,([Substance]) Usage,Char,R/C,"Check the appropriate box to indicate if the subject has ever used/consumed tobacco/alcohol/caffeine, currently consumes tobacco/alcohol/caffeine, or formerly used/consumed tobacco/alcohol/caffeine.",SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF; SUPPSU.QVAL,This does not map directly to a tabulation variable. May be used to populate SUOCCUR and relative timing variables.,(NCF),(SUNCF),"The 3 options (NEVER, CURRENT, FORMER) are applicant-defined in relation to the protocol. If the applicant has specific definitions, these definitions are detailed in the instructions to the site. As this type of response does not correspond exactly to a tabulation variable, collection variable SUNCF is recommended. Applicants must decide how to populate the appropriate relative timing variables when creating the tabulation datasets. For example, If SUNCF =""Never"", the value of SUOCCUR will be ""N"" and all relative timing variables will be null. If the applicant chooses to populate the relative start references (SUSTRTPT, SUSTRF) the value will be ""BEFORE"" when SUNCF= ""CURRENT"" and ""FORMER"". If the applicant also chooses to use relative end references (SUENRF, SUENRTPT), the SUENRTPT value will be ""ONGOING"" when SUNCF=""CURREN"" while the value of SUENRF will be ""DURING/AFTER"". \n Note: When using SUSTRTPT and/or SUENRTPT, these must refer to a time-point anchor (e.g., SCREENING, in SUSTTPT/SUENTPT).",9
Interventions,SU,N/A,N/A,10,SUSPID,Substance Use Applicant-Defined Identifier,"A applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field.",[Applicant-defined question],[Applicant defined],Char,O,"If collected on the CRF, applicants may insert instructions to ensure each record has a unique identifier.",SUSPID,Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain.,N/A,N/A,"Because SPID is an applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile data. May be used to record pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the applicant's data collection system.",10
Interventions,SU,N/A,N/A,11,SUREASND,Reason Substance Use Not Collected,An explanation for why data are not available.,What was the reason the data was not collected?,Reason Not Collected,Char,O,Provide the reason why the substance used data were not collected.,SUREASND,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"The reason data are not available may be chosen from an applicant-defined list (e.g., subject refused) or entered as free text. When PRREASND is used, the tabulation variable PRSTAT should also be populated in the tabulation dataset.",11
Interventions,SU,N/A,N/A,12,SUDSTXT,Substance Dose Description,"The amount of substance used (e.g., 1-2 packs, 8 oz).",What is/was the amount of [SUTRT] used/consumed?,Amount,Char,O,Check the appropriate box to indicate the amount of tobacco/alcohol/caffeine the subject consumes on a regular basis.,SUDOSE; SUDOSU; SUDOSTXT,"This does not map directly to a tabulation variable. Numeric values map to SUDOSE in the tabulation dataset. Non-numeric values (e.g., 200-400) map to SUDOSTXT in the tabulation dataset.",N/A,N/A,"Where possible, the options for dose/amount are pre-printed on the CRF. In the example given in the definition, ""packs"" and ""ounces"" are included as a point of reference. They would be represented as SUDOSU. Care should be taken to map each record to the appropriate tabulation 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 tabulation variable listed in the Tabulation Target column.,(FREQ),N/A,"When possible, the options for dose/amount frequency are pre-printed on the CRF. (e.g., PER DAY, PER WEEK, OCCASIONAL).",13
Interventions,SU,N/A,N/A,14,SUSTDAT,Substance Use Start Date,"The date substance use started, represented in an unambiguous date format (e.g., DD-MON-YYYY.",What was the start date of [SUTRT/SUCAT] use/consumption?,Start Date,Char,O,Record the start date of the substance use using this format (DD-MON-YYYY).,SUSTDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable SUSTDTC in ISO 8601 format.",N/A,N/A,"The applicant 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 a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable SUENDTC in ISO 8601 format.",N/A,N/A,"The applicant 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 a tabulation variable. For the tabulation dataset, concatenating the collected duration and collected duration unit and populate the tabulation 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 a tabulation variable. For the tabulation dataset, concatenating the collected duration and collected duration unit and populate the tabulation variable SUDUR in ISO 8601 format. Example: P1DT2H (for 1 day, 2 hours).",(UNIT),N/A,Applicant-defined options should be pre-printed on the CRF to avoid making this a free-text field. This will allow the response to be translated into ISO 8601 format.,17
Interventions,SU,N/A,N/A,18,SUMODIFY,Modified Substance Name,"If the value for SUTERM is modified for coding purposes, then the modified text is placed here.",N/A,N/A,Char,O,N/A,SUMODIFY,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This is not a data collection field that would appear on the CRF. If the applicant chooses to code the substance use, the applicant will populate this through the coding process.",18
Interventions,SU,N/A,N/A,19,SUDECOD,Standardized Substance Name,"The dictionary or applicant-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 tabulation variable listed in the Tabulation Target column.,N/A,N/A,"This is typically not a data collection field that will appear on the CRF. If the applicant chooses to code the substance use, the applicant will populate this through the coding process. Equivalent to the generic drug name in published (e.g., WHODrug, SNOMED, ICD9) or applicant-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 tabulation SUDECOD variable.",19
Special-Purpose,DM,Birth date collection using three date fields,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",1
Special-Purpose,DM,Birth date collection using three date fields,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",2
Special-Purpose,DM,Birth date collection using three date fields,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",3
Special-Purpose,DM,Birth date collection using three date fields,N/A,4,BRTHDD,Birth Day,"Day of birth of the subject, in an unambiguous date format (e.g., DD).",What is the subject's day of birth?,Birth Day,Char,R/C,"Record the subject's day of birth (e.g., 01 or 31).",BRTHDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 applicant 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 applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then tabulation variable AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",4
Special-Purpose,DM,Birth date collection using three date fields,N/A,5,BRTHMO,Birth Month,"Month of birth of the subject, in an unambiguous date format (e.g., MMM).",What is the subject's month of birth?,Birth Month,Char,R/C,"Record the subject's month of birth [e.g., (in local language short month format) (JAN-DEC) or (ENE-DIE) or (JAN-DEZ), etc.].",BRTHDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 applicant 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 applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE), if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",5
Special-Purpose,DM,Birth date collection using three date fields,N/A,6,BRTHYY,Birth Year,"The year of birth of the subject, in an unambiguous date format (e.g., YYYY).",What is the subject's year of birth?,Birth Year,Char,R/C,"Record the subject's year of birth (e.g., YYYY, a four-digit year).",BRTHDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 applicant 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 applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",6
Special-Purpose,DM,Birth date collection using three date fields,N/A,7,BRTHTIM,Birth Time,"The time of birth of the subject, in an unambiguous time format (e.g., hh:mm).",What is the subject's time of birth?,Birth Time,Char,O,Record the time of birth (as completely as possible).,BRTHDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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 applicant 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 applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",7
Special-Purpose,DM,Birth date collection using three date fields,N/A,8,AGE,Age,"The age of the subject, expressed in AGEU.",What is the subject's age?,Age,Num,O,Record age of the subject.,AGE,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"If age is collected, it should be collected as a number and, to be correctly interpreted, the age value should be associated to a variable for the age unit. It may be necessary to know when the age was collected, as age may need to be recalculated for analysis, such as deriving age at a reference start time (tabulation variable RFSTDTC). BRTHDTC may not be available in all cases (due to subject privacy concerns). If AGE is collected, then it is recommended that the date of collection also be recorded, either separately or by association to the date of the visit.",8
Special-Purpose,DM,Birth date collection using three date fields,N/A,9,AGEU,Age Units,Units of time routinely used to express the age of a person.,What is the age unit used?,Age Unit,Char,O,"Record the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, etc.).",AGEU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(AGEU),N/A,"If age is captured on the CRF, the age unit must be known to make the age value meaningful. The age unit might be collected on the CRF, in those cases where the protocol allows for any age group, or it may be pre-printed on the CRF (typically with the unit of ""years"").",9
Special-Purpose,DM,Birth date collection using three date fields,N/A,10,DMDAT,Demographics Collection Date,"The date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What is the date of collection?,Collection Date,Char,R/C,Record the date of collection using this format (DD-MON-YYYY). ,DMDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DMDTC in ISO 8601 format.",N/A,N/A,"The date of collection may be determined from the date of visit; if so, a separate date field is not needed.",10
Special-Purpose,DM,Birth date collection using three date fields,N/A,11,SEX,Sex,Sex of the subject. ,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 tabulation variable listed in the Tabulation Target column.,(SEX),N/A,"Collect the subject's sex or gender, This is a phenotypic assessment and not a genotypic assessment.",11
Special-Purpose,DM,Birth date collection using three date fields,N/A,12,ETHNIC,Ethnicity,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin, and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease.",Do you consider yourself Hispanic/Latino or not Hispanic/Latino?,Ethnicity,Char,O,"Study participants should self-report ethnicity, with ethnicity being asked about before race.",ETHNIC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ETHNIC),N/A,"When creating the DM form, regulatory guidance will be followed. Use ETHNIC when higher-level ethnicity categorizations are desired. Applicant may append a suffix to denote multiple collected ethnicities (e.g., ETHNIC1, ETHNIC2).",12
Special-Purpose,DM,Birth date collection using three date fields,N/A,13,CETHNIC,Collected Ethnicity,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin, and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease.",What is the ethnicity of the subject?,Ethnicity,Char,O,"Study participants should self-report ethnicity, with ethnicity being asked about before race.",SUPPDM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "CETHNIC" and SUPPDM.QLABEL= "Collected Ethnicity".,(ETHNICC),N/A,"When creating the DM form, regulatory guidance will be followed. Use ETHNICC when more detailed ethnicity categorizations are desired. Applicants may append a suffix to denote multiple collected ethnicities (e.g., ETHNICC1, ETHNICC2).",13
Special-Purpose,DM,Birth date collection using three date fields,N/A,14,RACE,Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Center for Disease Control).,Which of the following five racial designations best describes you? (More than one choice is acceptable.),Race,Char,R/C,"Study participants should self-report race, with race being asked about after ethnicity.",RACE,Maps directly to the tabulation variable listed in the Tabulation Target column.,(RACE),N/A,"When creating the DM form, regulatory guidance will be followed. Use RACE when higher-level race categorizations are desired. If multiple races are collected, an alternate applicant-defined variable structure would be required. Applicants may record multiple races for a subject by appending a suffix to denote multiple collected races (e.g., RACE1, RACE2) and populate RACE with the value MULTIPLE.",14
Special-Purpose,DM,Birth date collection using three date fields,N/A,15,CRACE,Collected Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Centers for Disease Control).,Which of the following racial designations best describes you? (More than 1 choice is acceptable.),Race,Char,R/C,"Study participants should self-report race, with race being asked about after ethnicity. (The FDA guidance suggests that individuals be permitted to designate a multiracial identity. Check all that apply at the time of collection).",SUPPDM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL when SUPPDM.QNAM = "CRACE" and SUPPDM.QLABEL="Collected Race".,(RACEC),N/A,"When creating the DM form, regulatory guidance will be followed. Use CRACE when more detailed race categorizations are desired. If multiple races are collected, an alternate applicant-defined variable structure would be required. Applicants may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g., CRACE1, CRACE2) and populate CRACE with the value MULTIPLE.",15
Special-Purpose,DM,Birth date collection using three date fields,N/A,16,RACEOTH,Race Other,"A free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values.",What was the other race?,Specify Other Race,Char,O,"If none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values, record the value in this free text field.",SUPPDM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "RACEOTH" and SUPP.QLABEL="RACE OTHER".,N/A,N/A,"When creating the DM form, regulatory guidance will be followed. Applicants may choose to include another value (""Specify, Other"") with a free-text field for extending the list of values. The RACEOTH variable contains the free text added by the site.",16
Special-Purpose,DM,Birth date collection using a single date field,N/A,1,STUDYID,Study Identifier,A unique identifier for a study.,What is the study identifier?,[Protocol/Study],Char,HR,N/A,STUDYID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.",17
Special-Purpose,DM,Birth date collection using a single date field,N/A,2,SITEID,Study Site Identifier,A unique identifier for a site within a study.,What is the site identifier?,Site (Identifier),Char,HR,N/A,DM.SITEID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. \n EDC: This should be pre-populated.",18
Special-Purpose,DM,Birth date collection using a single date field,N/A,3,SUBJID,Subject Identifier for the Study,A unique subject identifier within a site and a study.,What [is/was] the (study) [subject/participant] identifier?,[Subject/Participant] (Identifier),Char,HR,Record the identifier for the subject.,DM.SUBJID,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain.",19
Special-Purpose,DM,Birth date collection using a single date field,N/A,4,BRTHDAT,Birth Date,"A subject's date of birth (with or without the time of birth). The complete Date of Birth is made from the temporal components of Birth Year, Birth Month, Birth Day, and Birth Time..",What is the subject's date of birth?,Birth Date,Char,R/C,"Record the date of birth to the level of precision known (e.g., day/month/year, year, month/year) in this format (DD-MON-YYYY).",BRTHDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable BRTHDTC in ISO 8601 format.",N/A,N/A,"BRTHDAT is the collected field used for recording the full birth date. The applicant 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 applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, selected components) is reported in the tabulation variable BRTHDTC in ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how age was determined and/or imputed for those birth dates collected with reduced precision.",20
Special-Purpose,DM,Birth date collection using a single date field,N/A,5,BRTHTIM,Birth Time,"The time of birth of the subject, in an unambiguous time format (e.g., hh:mm).",What is the subject's time of birth?,Birth Time,Char,O,Record the time of birth (as completely as possible).,BRTHDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation 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. Applicants 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 applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.",21
Special-Purpose,DM,Birth date collection using a single date field,N/A,6,AGE,Age,"The age of the subject, expressed in AGEU.",What is the subject's age?,Age,Num,O,Record age of the subject.,AGE,Maps directly to the tabulation variable listed in the Tabulation Target column.,N/A,N/A,"If age is collected, it should be collected as a number and, to be correctly interpreted, the age value should be associated to a variable for the age unit. It may be necessary to know when the age was collected, as age may need to be recalculated for analysis, such as deriving age at a reference start time (tabulation variable RFSTDTC). BRTHDTC may not be available in all cases (due to subject privacy concerns). If AGE is collected, then it is recommended that the date of collection also be recorded, either separately or by association to the date of the visit.",22
Special-Purpose,DM,Birth date collection using a single date field,N/A,7,AGEU,Age Units,Units of time that are routinely used to express the age of a person,What is the age unit used?,Age Unit,Char,O,"Record the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, etc.).",AGEU,Maps directly to the tabulation variable listed in the Tabulation Target column.,(AGEU),N/A,"If age is captured on the CRF, the age unit must be known to make the age value meaningful. The age unit might be collected on the CRF, in those cases where the protocol allows for any age group, or it may be pre-printed on the CRF (typically with the unit of ""years"").",23
Special-Purpose,DM,Birth date collection using a single date field,N/A,8,DMDAT,Demographics Collection Date,"The date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).",What is the date of collection?,Collection Date,Char,R/C,Record the date of collection using this format (DD-MON-YYYY).,DMDTC,"This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DMDTC in ISO 8601 format.",N/A,N/A,"The date of collection may be determined from the date of visit; if so, a separate date field is not needed.",24
Special-Purpose,DM,Birth date collection using a single date field,N/A,9,SEX,Sex,Sex of the subject.,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 tabulation variable listed in the Tabulation Target column.,(SEX),N/A,"Collect the subject's sex or gender, as reported by the investigator. This is a phenotypic assessment and not a genotypic assessment.",25
Special-Purpose,DM,Birth date collection using a single date field,N/A,10,ETHNIC,Ethnicity,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease..",Do you consider yourself Hispanic/Latino or not Hispanic/Latino?,Ethnicity,Char,O,"Study participants should self-report ethnicity, with ethnicity being asked about before race.",ETHNIC,Maps directly to the tabulation variable listed in the Tabulation Target column.,(ETHNIC),N/A,"When creating the DM form, regulatory guidance will be followed. Use ETHNIC when higher-level ethnicity categorizations are desired. Applicant may append a suffix to denote multiple collected ethnicities (e.g. ETHNIC1, ETHNIC2).",26
Special-Purpose,DM,Birth date collection using a single date field,N/A,11,CETHNIC,Collected Ethnicity,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences, and often a common genetic heritage; these features may be reflected in their experience of health and disease.",What is the ethnicity of the subject?,Ethnicity,Char,O,"Study participants should self-report ethnicity, with ethnicity being asked about before race.",SUPPDM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "CETHNIC" and SUPPDM.QLABEL= "Collected Ethnicity".,(ETHNICC),N/A,"When creating the DM form, regulatory guidance will be followed. Use ETHNICC when more detailed ethnicity categorizations are desired. Applicants may append a suffix to denote multiple collected ethnicities (e.g. ETHNICC1, ETHNICC2).",27
Special-Purpose,DM,Birth date collection using a single date field,N/A,12,RACE,Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Center for Disease Control).,Which of the following five racial designations best describes you? (More than one choice is acceptable.),Race,Char,R/C,"Study participants should self-report race, with race being asked about after ethnicity.",RACE,Maps directly to the tabulation variable listed in the Tabulation Target column.,(RACE),N/A,"When creating the DM form, regulatory guidance will be followed. Use RACE when higher level race categorizations are desired. If multiple races are collected, an alternate applicant-defined variable structure would be required. Applicants may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g. RACE1, RACE2) and populate RACE with the value MULTIPLE.",28
Special-Purpose,DM,Birth date collection using a single date field,N/A,13,CRACE,Collected Race,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Centers for Disease Control).,Which of the following racial designations best describes you? (More than one choice is acceptable.),Race,Char,R/C,"Study participants should self-report race, with race being asked about after ethnicity. (The FDA guidance suggests that individuals be permitted to designate a multiracial identity. Check all that apply at the time of collection).",SUPPDM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL when SUPPDM.QNAM = "CRACE" and SUPPDM.QLABEL="Collected Race".,(RACEC),N/A,"When creating the DM form, regulatory guidance will be followed. Use CRACE when more detailed race categorizations are desired. If multiple races are collected, an alternate applicant-defined variable structure would be required. Applicants may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g. CRACE1, CRACE2) and populate CRACE with the value MULTIPLE.",29
Special-Purpose,DM,Birth date collection using a single date field,N/A,14,RACEOTH,Race Other,"A free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values.",What was the other race?,Specify Other Race,Char,O,"If none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values, record the value in this free-text field.",SUPPDM.QVAL,This does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "RACEOTH" and SUPP.QLABEL="RACE OTHER".,N/A,N/A,"When creating the DM form, regulatory guidance will be followed. Applicants may choose to include another value (""Specify, Other"") with a free-text field for extending the list of values. The RACEOTH variable contains the free text added by the site.",30
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TIG v1.0 CDASH Metadata Staging
