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Not for use outside of human clinical trials.

SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1

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 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.

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