SDTM.SV

Rows Columns

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.
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	1. Clinical encounter number. (Decimal numbering may be useful for inserting unplanned visits.) 2. Numeric version of VISIT, used for sorting.
5	SV	VISIT	Visit Name	Char		Synonym Qualifier	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter.
6	SV	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the start of the visit based upon RFSTDTC in Demographics.
7	SV	SVSTDTC	Start Date/Time of Visit	Char	ISO 8601	Timing	Exp	Start date/time for a Visit.
8	SV	SVENDTC	End Date/Time of Visit	Char	ISO 8601	Timing	Exp	End date/time of a Visit.
9	SV	SVSTDY	Study Day of Start of Visit	Num		Timing	Perm	Study day of start of visit relative to the sponsor-defined RFSTDTC.
10	SV	SVENDY	Study Day of End of Visit	Num		Timing	Perm	Study day of end of visit relative to the sponsor-defined RFSTDTC.
11	SV	SVUPDES	Description of Unplanned Visit	Char		Synonym Qualifier	Perm	Description of what happened to the subject during an unplanned visit.

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