Demographics
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA
text
Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): DM
Role: Identifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Topic CDISC Notes (for domains) Description (for General Classes): Subject identifier, which must be unique within the study. Often the ID of the subject as recorded on a CRF. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): ISO 8601
datetime
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): ISO 8601
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): First date/time of exposure to any protocol-specified treatment or therapy, equal to the earliest value of EXSTDTC. Controlled Terms or Format (if applicable): ISO 8601
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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). Controlled Terms or Format (if applicable): ISO 8601
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): ISO 8601
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): ISO 8601
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): ISO 8601
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Indicates the subject died. Should be "Y" or null. Should be populated even when the death date is unknown. Controlled Terms or Format (if applicable): (NY)
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a site within a study. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): An identifier to describe the Investigator for the study. May be used in addition to SITEID. Not needed if SITEID is equivalent to INVID. Controlled Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Name of the investigator for a site. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Date/time of birth of the subject. Controlled Terms or Format (if applicable): ISO 8601
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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). Controlled Terms or Format (if applicable): NA
float
Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Units associated with AGE. Controlled Terms or Format (if applicable): (AGEU), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Sex of the subject. Controlled Terms or Format (if applicable): (SEX), not extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): (RACE), not extensible (here RACEC (race as collected) used, extensible, and RACE Codelistitems marked in their comments)
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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). Controlled Terms or Format (if applicable): (ETHNIC), not extensible (ETHNICC, extensbile, used here and ETHNIC codelistitems marked as such in their comments)
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 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. Controlled Terms or Format (if applicable): NA, extensible
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): A description of actual treatment for a subject who did not receive treatment described in one of the planned trial Arms. Controlled Terms or Format (if applicable): NA
Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Country of the investigational site in which the subject participated in the trial. Controlled Terms or Format (if applicable): ISO 3166-1 Alpha-3
Role: Timing CDISC Notes (for domains) Description (for General Classes): Date/time of demographic data collection. Controlled Terms or Format (if applicable): ISO 8601
Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of collection measured as integer days. Controlled Terms or Format (if applicable): NA
integer