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 e | 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"). 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 for to categorize as a 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 below). |
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. |