| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | TI | Identifier | Two-character abbreviation for the domain. | Req |
| IETESTCD | Incl/Excl Criterion Short Name | Char | * |
| Topic | 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. | Req |
| IETEST | Inclusion/Exclusion Criterion | Char | * |
| Synonym Qualifier | Full text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain. | Req |
| IECAT | Inclusion/Exclusion Category | Char | (IECAT) | Grouping Qualifier | Used for categorization of the inclusion or exclusion criteria. | Req |
| IESCAT | Inclusion/Exclusion Subcategory | Char* |
| Grouping Qualifier | 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". | Perm |
| TIRL | Inclusion/Exclusion Criterion Rule | Char |
| Rule | Rule that expresses the criterion in computer-executable form. See Assumption 4. | Perm |
| TIVERS | Protocol Criteria Versions | Char |
| Record Qualifier | The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only 1 version. | Perm |