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Subject Visits describes the actual start and end date/time for each visit of each individual subject. Planned trial visits are described in the Trial Design Model (see Section 5.1.4.1, Trial Visits). Because actual data does not always follow the plan, the SDTM allows for descriptions of unplanned visits for subjects (SVUPDES).

See the implementation guides for further guidance regarding use of additional identifier and timing variables.


SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

#Variable NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082A sequence of characters used by the sponsor to uniquely identify the study.

2DOMAINDomain AbbreviationChar
Identifier

C49558An abbreviation for a collection of observations, with a topic-specific commonality.2-character abbreviation, which must be "SV".
3USUBJIDUnique Subject IdentifierChar
Identifier

C69256A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.

4VISITNUMVisit NumberNum
Topic

C83101An assigned numeric identifier that aligns to the chronological order of a clinical encounter.Decimal numbering may be useful for inserting unplanned visits. Used for sorting.
5VISITVisit NameChar
Synonym QualifierVISITNUM
C171010The label for a protocol-defined clinical encounter.May be used in addition to VISITNUM and/or VISITDY.
6SVPRESPPre-SpecifiedChar
Variable QualifierVISITNUM


An indication that the visit is planned. Values should be "Y" or null.
7SVOCCUROccurrenceChar
Record Qualifier



An indication as to whether a prespecified (planned) visit has occurred.
8SVREASOCReason for Occur ValueChar
Record Qualifier



The reason for the value in SVOCCUR. If SVOCCUR="N", SVREASOC is the reason the visit did not occur.
9SVCNTMODContact ModeChar
Record Qualifier



The way in which the visit or contact was conducted."IN PERSON", "TELEPHONE", "IVRS".
10SVEPCHGIEpi/Pandemic Related Change IndicatorChar
Record Qualifier



Indicates whether the visit was changed due to an epidemic or pandemic.
11VISITDYPlanned Study Day of VisitNum
Timing

C171011The planned study day of a clinical encounter relative to the sponsor-defined reference start date.The reference start date is RFSTDTC in Demographics.
12SVSTDTCStart Date/Time of VisitCharISO 8601 datetime or intervalTiming



Start date or start date and time for a subject's visit.
13SVENDTCEnd Date/Time of VisitCharISO 8601 datetime or intervalTiming



End date/time of a subject's visit.
14SVSTDYStudy Day of Start of VisitNum
Timing



Study day of start of visit relative to the sponsor-defined RFSTDTC.
15SVENDYStudy Day of End of VisitNum
Timing



Study day of end of visit relative to the sponsor-defined RFSTDTC.
16SVUPDESDescription of Unplanned VisitChar
Record Qualifier



Description of what happened to the subject during an unplanned visit. Null for protocol-defined visits.

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