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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 DM STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 DM DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 DM USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. This must be a unique number, and could be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID.
4 DM SUBJID Subject Identifier for the Study Char Topic Req Subject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF.
5 DM RFSTDTC Subject Reference Start Date/Time Char ISO 8601 Record Qualifier Exp Reference 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.
6 DM RFENDTC Subject Reference End Date/Time Char ISO 8601 Record Qualifier Exp Reference 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.
7 DM RFXSTDTC Date/Time of First Study Treatment Char ISO 8601 Record Qualifier Exp First date/time of exposure to any protocol-specified treatment or therapy, equal to the earliest value of EXSTDTC.
8 DM RFXENDTC Date/Time of Last Study Treatment Char ISO 8601 Record Qualifier Exp Last 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).
9 DM RFICDTC Date/Time of Informed Consent Char ISO 8601 Record Qualifier Exp Date/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.
10 DM RFPENDTC Date/Time of End of Participation Char ISO 8601 Record Qualifier Exp Date/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, or death date.
11 DM DTHDTC Date/Time of Death Char ISO 8601 Record Qualifier Exp Date/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.
12 DM DTHFL Subject Death Flag Char C66742 Record Qualifier Exp Indicates the subject died. Should be "Y" or null. Should be populated even when the death date is unknown.
13 DM SITEID Study Site Identifier Char Record Qualifier Req Unique identifier for a site within a study.
14 DM INVID Investigator Identifier Char Record Qualifier Perm An identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID.
15 DM INVNAM Investigator Name Char Synonym Qualifier Perm Name of the investigator for a site.
16 DM BRTHDTC Date/Time of Birth Char ISO 8601 Record Qualifier Perm Date/time of birth of the subject.
17 DM AGE Age Num Record Qualifier Exp Age expressed in AGEU. May be derived from RFSTDTC and BRTHDTC, but BRTHDTC may not be available in all cases (due to subject privacy concerns).
18 DM AGEU Age Units Char C66781 Variable Qualifier Exp Units associated with AGE.
19 DM SEX Sex Char C66731 Record Qualifier Req Sex of the subject.
20 DM RACE Race Char C74457 Record Qualifier Exp Race of the subject. Sponsors should refer to "Collection of Race and Ethnicity Data in Clinical Trials" (FDA, October, 2016) for guidance regarding the collection of race (https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126396.pdf) See Assumption below regarding RACE.
21 DM ETHNIC Ethnicity Char C66790 Record Qualifier Perm The ethnicity of the subject. Sponsors should refer to "Collection of Race and Ethnicity Data in Clinical Trials" (FDA, October, 2016) for guidance regarding the collection of ethnicity (https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126396.pdf).
22 DM ARMCD Planned Arm Code Char Record Qualifier Exp 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 seven-period crossover were constructed using two-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20. If the subject was not assigned to an Arm, ARMCD is null and ARMNRS is populated. With the exception of studies which use multi-stage Arm assignments, must be a value of ARMCD in the Trial Arms Dataset.
23 DM ARM Description of Planned Arm Char Synonym Qualifier Exp 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 multi-stage Arm assignments, must be a value of ARM in the Trial Arms Dataset.
24 DM ACTARMCD Actual Arm Code Char Record Qualifier Exp 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 multi-stage 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.
25 DM ACTARM Description of Actual Arm Char Synonym Qualifier Exp Description of actual Arm. With the exception of studies which use multi-stage 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.
26 DM ARMNRS Reason Arm and/or Actual Arm is Null Char Record Qualifier Exp A 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.
27 DM ACTARMUD Description of Unplanned Actual Arm Char Record Qualifier Exp A description of actual treatment for a subject who did not receive treatment described in one of the planned trial Arms.
28 DM COUNTRY Country Char ISO 3166-1 Alpha-3 Record Qualifier Req Country of the investigational site in which the subject participated in the trial.
29 DM DMDTC Date/Time of Collection Char ISO 8601 Timing Perm Date/time of demographic data collection.
30 DM DMDY Study Day of Collection Num Timing Perm Study day of collection measured as integer days.