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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. 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.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

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
  • Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>

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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