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

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

C83082

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



2DOMAINDomain AbbreviationChar
Identifier

C49558

An abbreviation for a collection of observations, with a topic-specific commonality.

2-character abbreviation, which must be "TV".
3VISITNUMVisit NumberNum
Topic

C83101An assigned numeric identifier that aligns to the chronological order of a clinical encounter.Numeric version of VISIT can be used for sorting.
4VISITVisit NameChar
Synonym QualifierVISITNUM
C171010The label for a protocol-defined clinical encounter.May be used in addition to VISITNUM and/or VISITDY.
5VISITDYPlanned Study Day of VisitNum
Timing

C171011The planned study day of a clinical encounter relative to the sponsor-defined reference start date.Due to its sequential nature can be used for sorting.
6ARMCDPlanned Arm CodeChar
Record Qualifier

C83216A short sequence of characters that represents the planned arm to which the subject was assigned.ARMCD is limited to 20 characters and does not have special character restrictions. If the timing of visits for a trial does not depend on which Arm a subject is in, then ARMCD should be null.
7ARMDescription of Planned ArmChar
Synonym QualifierARMCD
C170984The name of the planned arm to which the subject was assigned.

8TVSTRLVisit Start RuleChar
Rule



Rule describing when the visit starts, in relation to the sequence of elements.
9TVENRLVisit End RuleChar
Rule



Rule describing when the visit ends, in relation to the sequence of elements.
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