Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 DS 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 DS 2 DOMAIN Domain Abbreviation Char DS Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 DS 3 USUBJID Unique Subject Identifier Char Identifier Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Req
SDTMIG 3.3 DS 4 DSSEQ Sequence Number Num Identifier Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 DS 5 DSGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 DS 6 DSREFID Reference ID Char Identifier Internal or external identifier. Perm
SDTMIG 3.3 DS 7 DSSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a Disposition page. Perm
SDTMIG 3.3 DS 8 DSTERM Reported Term for the Disposition Event Char Topic Verbatim name of the event or protocol milestone. Some terms in DSTERM will match DSDECOD, but others, such as "Subject moved" will map to controlled terminology in DSDECOD, such as "LOST TO FOLLOW-UP". Req
SDTMIG 3.3 DS 9 DSDECOD Standardized Disposition Term Char (NCOMPLT), (PROTMLST) Synonym Qualifier Controlled terminology for the name of disposition event or protocol milestone. Examples of protocol milestones: "INFORMED CONSENT OBTAINED", "RANDOMIZED". There are separate codelists used for DSDECOD where the choice depends on the value of DSCAT. Codelist "NCOMPLT" is used for disposition events and codelist "PROTMLST" is used for protocol milestones. The variable may be subject to controlled terminology for other events. Req
SDTMIG 3.3 DS 10 DSCAT Category for Disposition Event Char (DSCAT) Grouping Qualifier Used to define a category of related records. Exp
SDTMIG 3.3 DS 11 DSSCAT Subcategory for Disposition Event Char Grouping Qualifier A further categorization of DSCAT (e.g., "STUDY PARTICIPATION", "STUDY TREATMENT" when DSCAT = "DISPOSITION EVENT"). Perm
SDTMIG 3.3 DS 12 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the event. Perm
SDTMIG 3.3 DS 13 DSDTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of the disposition observation represented in ISO 8601 character format. Perm
SDTMIG 3.3 DS 14 DSSTDTC Start Date/Time of Disposition Event Char ISO 8601 Timing Start date/time of the disposition event in ISO 8601 character format. Exp
SDTMIG 3.3 DS 15 DSDY Study Day of Collection Num Timing Start date/time of the disposition event in ISO 8601 character format. Exp
SDTMIG 3.3 DS 16 DSSTDY Study Day of Start of Disposition Event Num Timing Study day of start of event relative to the sponsor-defined RFSTDTC. Perm