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Not for use in non-clinical trials.

Metadataspec
highlighttruekeysNotes;Core;Description
shareqc_sdtmig34sdtm4tig10_ds
ClassTrial Design
DomainTV
Variable NameVariable LabelTypeControlled Terms, Codelist, or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharTVIdentifierTwo-character abbreviation for the domain.Req
VISITNUMVisit NumberNum
TopicClinical encounter number.
  1. An assigned numeric identifier that aligns to the chronological order of an encounter.
  1. Numeric version of VISIT, used for sorting.
Req
VISITVisit NameChar
Synonym Qualifier
  1. The label for a protocol-defined encounter.
  2. May be used in
Description of clinical encounter. This is often defined in the protocol. Used in
  1. addition to VISITNUM and/or VISITDY
as a text description of the clinical encounter
  1. .
Req
VISITDYPlanned Study Day of VisitNum
Timing

Planned study day of VISIT. Due to its sequential nature, used for sorting.

Perm
ARMCDPlanned Arm CodeChar*
Record Qualifier
  1. ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than for other "short" variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each treatment product and separating hyphens, the length of ARMCD values would be 20.
  2. If the timing of visits for a trial does not depend on which arm a subject is in, then ARMCD should be null.
Exp
ARMDescription of Planned ArmChar*
Synonym Qualifier
  1. Name given to an arm or treatment product exposure group.
  2. If the timing of visits for a trial does not depend on which arm a subject is in, then Arm should be left blank.
Perm
TVSTRLVisit Start RuleChar
RuleRule describing when the visit starts, in relation to the sequence of elements.Req
TVENRLVisit End RuleChar
RuleRule describing when the visit ends, in relation to the sequence of elements.Perm
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.