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Metadataspec
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keysNotes;Core;Description
shareqc_sdtmig34sdtm4tig10_ds
ClassTrial Design
DomainTI
Variable NameVariable LabelTypeControlled Terms, Codelist, or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharTIIdentifierTwo-character abbreviation for the domain.Req
IETESTCDIncl/Excl Criterion Short NameChar*
TopicShort name IETEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). IETESTCD cannot contain characters other than letters, numbers, or underscores. The prefix "IE" is used to ensure consistency with the IE domain.Req
IETESTInclusion/Exclusion CriterionChar*
Synonym QualifierFull text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain.Req
IECATInclusion/Exclusion CategoryChar(IECAT)Grouping QualifierUsed for categorization of the inclusion or exclusion criteria.Req
IESCATInclusion/Exclusion SubcategoryChar*
Grouping QualifierA further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or to categorize as major or minor exceptions. Examples: "MAJOR", "MINOR".Perm
TIRLInclusion/Exclusion Criterion RuleChar
RuleRule that expresses the criterion in computer-executable form. See Assumption 4.Perm
TIVERSProtocol Criteria VersionsChar
Record QualifierThe number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only 1 version.Perm
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.