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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 TI STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 TI DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 TI IETESTCD Incl/Excl Criterion Short Name Char Topic Req Short 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.
4 TI IETEST Inclusion/Exclusion Criterion Char Synonym Qualifier Req Full text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain.
5 TI IECAT Inclusion/Exclusion Category Char C66797 Grouping Qualifier Req Used for categorization of the inclusion or exclusion criteria.
6 TI IESCAT Inclusion/Exclusion Subcategory Char Grouping Qualifier Perm A 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".
7 TI TIRL Inclusion/Exclusion Criterion Rule Char Rule Perm Rule that expresses the criterion in computer-executable form. See Assumption 4.
8 TI TIVERS Protocol Criteria Versions Char Record Qualifier Perm The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only one version.