SDTM SV Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Variable Name	Variable Label	Type	Controlled Terms, Codelist or Format¹	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	SV	Identifier	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.	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
VISITNUM	Visit Number	Num		Topic	Clinical encounter number. Numeric version of VISIT, used for sorting.	Req
VISIT	Visit Name	Char		Synonym Qualifier	Protocol-defined description of a clinical encounter.	Perm
SVPRESP	Pre-specified	Char	(NY)	Variable Qualifier	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.	Exp
SVOCCUR	Occurrence	Char	(NY)	Record Qualifier	Used to record whether a planned visit occurred. The value is null for unplanned visits.	Exp
SVREASOC	Reason for Occur Value	Char		Record Qualifier	The reason for the value in SVOCCUR. If SVOCCUR="N", SVREASOC is the reason the visit did not occur.	Perm
SVCNTMOD	Contact Mode	Char	(CNTMODE)	Record Qualifier	The way in which the visit was conducted. Examples: "IN PERSON", "TELEPHONE CALL", "IVRS".	Perm
SVEPCHGI	Epi/Pandemic Related Change Indicator	Char	(NY)	Record Qualifier	Indicates whether the visit was changed due to an epidemic or pandemic.	Perm
VISITDY	Planned Study Day of Visit	Num		Timing	Planned study day of VISIT. Should be an integer.	Perm
SVSTDTC	Start Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing	Start date/time of an observation represented in IS0 8601 character format.	Exp
SVENDTC	End Date/Time of Observation	Char	ISO 8601 datetime or interval	Timing	End date/time of the observation represented in IS0 8601 character format.	Exp
SVSTDY	Study Day of Start of Observation	Num		Timing	Actual study day of start of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.	Perm
SVENDY	Study Day of End of Observation	Num		Timing	Actual study day of end of observation expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics.	Perm
SVUPDES	Description of Unplanned Visit	Char		Record Qualifier	Description of what happened to the subject during an unplanned visit. Only populated for unplanned visits.	Perm

Metadata Checks Findings

Metadata Check User Macros FAQ

Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>

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SDTM SV Specification