SDTM.SV

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	SV	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	SV	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain most relevant to the observation. The domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged.
3	SV	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	SV	VISITNUM	Visit Number	Num		Topic	Req	Clinical encounter number. Numeric version of VISIT, used for sorting.
5	SV	VISIT	Visit Name	Char		Synonym Qualifier	Perm	Protocol-defined description of a clinical encounter.
6	SV	SVPRESP	Pre-specified	Char	C66742	Variable Qualifier	Exp	Used to indicate whether the visit was planned (i.e., visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned visits.
7	SV	SVOCCUR	Occurrence	Char	C66742	Record Qualifier	Exp	Used to record whether a planned visit occurred. The value is null for unplanned visits.
8	SV	SVREASOC	Reason for Occur Value	Char		Record Qualifier	Perm	The reason for the value in SVOCCUR. If SVOCCUR="N", SVREASOC is the reason the visit did not occur.
9	SV	SVCNTMOD	Contact Mode	Char	C171445	Record Qualifier	Perm	The way in which the visit was conducted. Examples: "IN PERSON", "TELEPHONE CALL", "IVRS".
10	SV	SVEPCHGI	Epi/Pandemic Related Change Indicator	Char	C66742	Record Qualifier	Perm	Indicates whether the visit was changed due to an epidemic or pandemic.
11	SV	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of VISIT. Should be an integer.
12	SV	SVSTDTC	Start Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing	Exp	Start date/time of an observation represented in IS0 8601 character format.
13	SV	SVENDTC	End Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing	Exp	End date/time of the observation represented in IS0 8601 character format.
14	SV	SVSTDY	Study Day of Start of Observation	Num		Timing	Perm	Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
15	SV	SVENDY	Study Day of End of Observation	Num		Timing	Perm	Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.
16	SV	SVUPDES	Description of Unplanned Visit	Char		Record Qualifier	Perm	Description of what happened to the subject during an unplanned visit. Only populated for unplanned visits.