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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. Required for all randomized subjects; will be null for all subjects who did not meet the milestone the date requires, such as screen failures or unassigned subjects.
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 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 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, September 2005) for guidance regarding the collection of race (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) 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, September 2005) for guidance regarding the collection of ethnicity (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm).
22 DM ARMCD Planned Arm Code Char Record Qualifier Req ARMCD is limited to 20 characters and does not have special character restrictions. 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.
23 DM ARM Description of Planned Arm Char Synonym Qualifier Req Name of the Arm to which the subject was assigned.
24 DM ACTARMCD Actual Arm Code Char Record Qualifier Req Code of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARMCD will be UNPLAN. Randomized subjects who were not treated will be given a value of NOTTRT. Values should be "SCRNFAIL" for screen failures and "NOTASSGN" for subjects not assigned to treatment. Restricted to values in Trial Arms in all other cases. ACTARMCD is limited to 20 characters and does not have special character restrictions. 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.
25 DM ACTARM Description of Actual Arm Char Synonym Qualifier Req Description of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARM will be "Unplanned Treatment". Randomized subjects who were not treated will be given a value of "Not Treated". Values should be "Screen Failure" for screen failures and "Not Assigned" for subjects not assigned to treatment. Restricted to values in Trial Arms in all other cases.
26 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.
27 DM DMDTC Date/Time of Collection Char ISO 8601 Timing Perm Date/time of demographic data collection.
28 DM DMDY Study Day of Collection Num Timing Perm Study day of collection measured as integer days.