SDTM.DS

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	DS	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	DS	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	DS	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.
4	DS	DSSEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	DS	DSGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	DS	DSREFID	Reference ID	Char		Identifier	Perm	Internal or external identifier.
7	DS	DSSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a Disposition page.
8	DS	DSTERM	Reported Term for the Disposition Event	Char		Topic	Req	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."
9	DS	DSDECOD	Standardized Disposition Term	Char	C66727	Synonym Qualifier	Req	Controlled terminology for the name of disposition event or protocol milestone. Examples of protocol milestones: INFORMED CONSENT OBTAINED, RANDOMIZED
10	DS	DSCAT	Category for Disposition Event	Char	C74558	Grouping Qualifier	Exp	Used to define a category of related records. DSCAT is now an "Expected" variable. DSCAT was permissible in SDTMIG 3.1.1 and earlier versions. The change from "permissible" to "expected" is based on the requirement to distinguish protocol milestones and/or other events from disposition events. DSCAT may be null if there are only "disposition events"; however, it is recommended that DSCAT always be populated.
11	DS	DSSCAT	Subcategory for Disposition Event	Char		Grouping Qualifier	Perm	A further categorization of disposition event.
12	DS	EPOCH	Epoch	Char	C99079	Timing	Perm	EPOCH may be used when DSCAT = "DISPOSITION EVENT". Examples: SCREENING, TREATMENT, FOLLOW-UP
13	DS	DSDTC	Date/Time of Collection	Char	ISO 8601	Timing	Perm
14	DS	DSSTDTC	Start Date/Time of Disposition Event	Char	ISO 8601	Timing	Exp
15	DS	DSSTDY	Study Day of Start of Disposition Event	Num		Timing	Perm	Study day of start of event relative to the sponsor-defined RFSTDTC.