[Translated from SDTM IG 3.2: www.cdisc.org]/SDTM
DM (Demographics): Special purpose domain, describes the basic information of subjects in clinical research, is the parent domain.
Variables:
RFSTDTC (Subject Reference Start Date/Time): Usually equal to the subject’s first medication time. Necessary for all random populations, assigned as empty for subjects who did not reach milestone events (e.g., Screen failure or unassigned).
RFENDTC (Subject Reference End Date/Time): Usually equal to the date when the subject ends the trial or the last medication time, necessary for all random populations, assigned as empty for subjects who did not reach milestone events (e.g., Screen failure or unassigned).
RFXSTDTC (Date/Time of First Study Treatment): The time of first exposure to any protocol-specified treatment, equal to the earliest EXSTDTC.
RFXENDTC (Date/Time of Last Study Treatment): The time of last exposure to any protocol-specified treatment, equal to the latest EXSTDTC. (If EXENDTC is not collected or missing, equal to the latest EXSTDTC).
RFICDTC (Date/Time of Informed Consent): The time of informed consent, i.e., the informed consent time in the DS domain.
RFPENDTC (Date/Time of End of Participation): The time when the subject stops participating in the trial or follow-up, defined in the Protocol. For a subject, it should equal the most completely recorded time throughout the trial, which can be the completion date, withdrawal date, last follow-up, lost to follow-up date, or death date.
ARMCD (Planned Arm Code): Up to 20 characters.
ARM (Description of Planned Arm): Name of the Arm to which the subject was assigned.
ACTARMCD (Actual Arm Code): The actual treatment arm, assigned as UNPLAN if an Arm is not planned. Subjects who did not receive treatment are assigned as NOTTRT. Screen failures are assigned as SCRNFAIL. Subjects without assigned treatment are assigned as NOTASSGN.
ACTARM (Description of Actual Arm): Correspondingly assigned as Unplanned Treatment, Not Treated, Screen Failure, Not Assigned.
Notes:
1. CDISC requires the provision of SITEID, INVID, and INVNAM as necessary for consistency.
2. Each subject must have SUBJID. If a subject participates in multiple studies, it is distinguished by USUBJID. For subjects transferring sites, the sponsor decides how to export USUBJID, SUBJID, SITEID based on operational and analytical needs. However, there should only be one record for such subjects in DM. Additional information can be recorded in SUPPDM.
4. ARM and ARMCD must be consistent with those in TA. For subjects already assigned but not treated, their ARM and ARMCD will still be assigned.
6. I If multiple races are collected, RACE=”MULTIPLE”, and specific information is stored in SUPPDM.
II If multiple races are collected and one is primary, the primary race is stored in DM, others are stored in SUPPDM.
III If free text is reported (“Other, Specify”), refer to 4.1.2.7.1. However, if the sponsor chooses not to follow FDA guidance mapping, then RACE=”OTHER”.
IV If a subject refuses to provide race information, then RACE=”UNKNOWN”.
11. RFXSTDTC is usually equal to RFSTDTC. However, sometimes RFSTDTC is defined as the informed consent time, then RFXSTDTC is the SESTDTC of the first treatment element.
12. RFXENDTC is usually equal to the SEENDTC of the last treatment element, which may be the same as RFENDTC.
13. RFICDTC is the time of the informed consent protocol milestone in DS; if multiple informed consents are signed (e.g., in multi-stage studies, informed consent is signed separately before Stage 2 treatment and Stage 3 extension treatment), it is the earliest time.
14. RFPENDTC will be the last date of participation for a subject for data included in a submission. This should be the last date of any record for the subject in the database at the time it’s locked for submission. As such, it may not be the last date of participation in the study if the submission includes interim data.
Other reference links:
1. RFSTDTC vs RFXSTDTC: http://doubledealer989.blog74.fc2.com/blog-entry-941.html
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