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Metadataspec
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keysDescription;Notes;Core
Shareqc_sdtmig34_ds
ClassSpecial Purpose
DomainDM
Variable NameVariable LabelTypeControlled Terms, Codelist or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharDMIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. This must be a unique value, and could be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID.Req
SUBJIDSubject Identifier for the StudyChar
TopicSubject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF.Req
RFSTDTCSubject Reference Start Date/TimeCharISO 8601 datetime or intervalRecord QualifierReference start date/time for the subject in ISO 8601 character format. Usually equivalent to date/time when subject was first exposed to study treatment. See assumption 9 for additional detail on when RFSTDTC may be null.Exp
RFENDTCSubject Reference End Date/TimeCharISO 8601 datetime or intervalRecord QualifierReference end date/time for the subject in ISO 8601 character format. Usually equivalent to the date/time when subject was determined to have ended the trial, and often equivalent to date/time of last exposure to study treatment. Required for all randomized subjects; null for screen failures or unassigned subjects.Exp
RFXSTDTCDate/Time of First Study TreatmentCharISO 8601 datetime or intervalRecord QualifierFirst date/time of exposure to any protocol-specified treatment or therapy, equal to the earliest value of EXSTDTC.Exp
RFXENDTCDate/Time of Last Study TreatmentCharISO 8601 datetime or intervalRecord QualifierLast date/time of exposure to any protocol-specified treatment or therapy, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing).Exp
RFCSTDTCDate/Time of First Challenge Agent AdminCharISO 8601 datetime or intervalRecord QualifierUsed only when protocol specifies a challenge agent to induce a condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Equal to the earliest value of AGSTDTC for the challenge agent.Perm
RFCENDTCDate/Time of Last Challenge Agent AdminCharISO 8601 datetime or intervalRecord QualifierUsed only when protocol specifies a challenge agent to induce a condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. Equal to the latest value of AGENDTC for the challenge agent (or the latest value of AGSTDTC if AGENDTC was not collected or is missing).Perm
RFICDTCDate/Time of Informed ConsentCharISO 8601 datetime or intervalRecord QualifierDate/time of informed consent in ISO 8601 character format. This will be the same as the date of informed consent in the Disposition domain, if that protocol milestone is documented. Would be null only in studies not collecting the date of informed consent.Exp
RFPENDTCDate/Time of End of ParticipationCharISO 8601 datetime or intervalRecord QualifierDate/time when subject ended participation or follow-up in a trial, as defined in the protocol, in ISO 8601 character format. Should correspond to the last known date of contact. Examples include completion date, withdrawal date, last follow-up, date recorded for lost to follow up, and death date.Exp
DTHDTCDate/Time of DeathCharISO 8601 datetime or intervalRecord QualifierDate/time of death for any subject who died, in ISO 8601 format. Should represent the date/time that is captured in the clinical-trial database.Exp
DTHFLSubject Death FlagChar(NY)Record QualifierIndicates the subject died. Should be "Y" or null. Should be populated even when the death date is unknown.Exp
SITEIDStudy Site IdentifierChar*Record QualifierUnique identifier for a site within a study.Req
INVIDInvestigator IdentifierChar
Record QualifierAn identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID.Perm
INVNAMInvestigator NameChar
Synonym QualifierName of the investigator for a site.Perm
BRTHDTCDate/Time of BirthCharISO 8601 datetime or intervalRecord QualifierDate/time of birth of the subject.Perm
AGEAgeNum
Record QualifierAge expressed in AGEU. May be derived from RFSTDTC and BRTHDTC, but BRTHDTC may not be available in all cases (due to subject privacy concerns).Exp
AGEUAge UnitsChar(AGEU)Variable QualifierUnits associated with AGE.Exp
SEXSexChar(SEX)Record QualifierSex of the subject.Req
RACERaceChar(RACE)Record QualifierRace of the subject. Sponsors should refer to the FDA guidance2 regarding the collection of race. See assumption below regarding RACE.Exp
ETHNICEthnicityChar(ETHNIC)Record QualifierThe ethnicity of the subject. Sponsors should refer to the FDA guidance1 regarding the collection of ethnicity.Perm
ARMCDPlanned Arm CodeChar*Record Qualifier

ARMCD is limited to 20 characters. It is not subject to the character restrictions that apply to TESTCD. The maximum length of ARMCD is longer than for other "short" variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20. If the subject was not assigned to a trial arm, ARMCD is null and ARMNRS is populated.

With the exception of studies which use multistage arm assignments, must be a value of ARMCD in the Trial Arms dataset.

Exp
ARMDescription of Planned ArmChar*Synonym Qualifier

Name of the arm to which the subject was assigned. If the subject was not assigned to an arm, ARM is null and ARMNRS is populated.

With the exception of studies which use multistage arm assignments, must be a value of ARM in the Trial Arms dataset.

Exp
ACTARMCDActual Arm CodeChar*Record Qualifier

Code of actual arm. ACTARMCD is limited to 20 characters. It is not subject to the character restrictions that apply to TESTCD. The maximum length of ACTARMCD is longer than for other short variables to accommodate the kind of values that are likely to be needed for crossover trials.

With the exception of studies which use multistage arm assignments, must be a value of ARMCD in the Trial Arms dataset.

If the subject was not assigned to an arm or followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is populated.

Exp
ACTARMDescription of Actual ArmChar*Synonym Qualifier

Description of actual arm.

With the exception of studies which use multistage arm assignments, must be a value of ARM in the Trial Arms dataset.

If the subject was not assigned to an arm or followed a course not described by any planned arm, ACTARM is null and ARMNRS is populated.

Exp
ARMNRSReason Arm and/or Actual Arm is NullChar(ARMNULRS)Record QualifierA coded reason that arm variables (ARM and ARMCD) and/or actual arm variables (ACTARM and ACTARMCD) are null. Examples: "SCREEN FAILURE", "NOT ASSIGNED", "ASSIGNED, NOT TREATED", "UNPLANNED TREATMENT". It is assumed that if the arm and actual arm variables are null, the same reason applies to both arm and actual arm.Exp
ACTARMUDDescription of Unplanned Actual ArmChar
Record QualifierA description of actual treatment for a subject who did not receive treatment described in a planned trial arm.Exp
COUNTRYCountryChar


Record Qualifier

Country of the investigational site in which the subject participated in the trial.

Generally represented using ISO 3166-1 Alpha-3. Note that regulatory agency specific requirements (e.g., US FDA) may require other terminologies; in such cases, follow regulatory requirements.

Req
DMDTCDate/Time of CollectionCharISO 8601 datetime or intervalTimingDate/time of demographic data collection.Perm
DMDYStudy Day of CollectionNum
TimingStudy day of collection measured as integer days.Perm

1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.

2Food and Drug Administration. Collection of Race and Ethnicity Data in Clinical Trials. US Department of Health and Human Services;2016. Accessed January 8, 2020. https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126396.pdf