SEND DS specification

Variable Name	Variable Label	Type	Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	DS	Identifier	Two-character abbreviation for the domain.	Req
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
DSSEQ	Sequence Number	Num		Identifier	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.	Req
DSTERM	Reported Term for the Disposition Event	Char		Topic	DSTERM is the original term recorded for subject disposition. DSTERM is not under controlled terminology, but should be mapped to DSDECOD.	Req
DSDECOD	Standardized Disposition Term	Char	(DSDECOD)	Synonym Qualifier	Contains the result in a standard format.	Req
DSUSCHFL	Unscheduled Flag	Char	(NY)	Record Qualifier	Indicates whether the subject's disposition was unscheduled. If the subject's disposition was based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null.	Exp
VISITDY	Planned Study Day of Disposition	Num		Timing	Planned study day of collection. Should be an integer. VISITDY should be populated only when DSTERM represents a scheduled activity.	Perm
DSSTDTC	Date/Time of Disposition	Char	ISO 8601	Timing	Date/Time of the disposition event, in ISO 8601 format.	Req
DSSTDY	Study Day of Disposition	Num		Timing	Study day of the disposition event, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.	Perm
DSNOMDY	Nominal Study Day for Tabulations	Num		Timing	Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer.	Exp
DSNOMLBL	Label for Nominal Study Day	Char		Timing	A label for a given value of DSNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac.	Perm

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SEND DS specification