Trial Inclusion/Exclusion contains 1 record for each of the inclusion and exclusion criterion for the trial. If eligibility criteria change during a trial, each version of the eligibility criteria may be represented.
Trial Inclusion/Exclusion—One Record per Trial Inclusion or Exclusion Criterion
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
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| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "TI". | ||||
| 3 | IETESTCD | Inclusion/Exclusion 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"). IETESTCD cannot contain characters other than letters, numbers, or underscores. The prefix "IE" is used to ensure consistency with the IE domain. | ||||||
| 4 | IETEST | Inclusion/Exclusion Criterion | Char | Synonym Qualifier | IETESTCD | Full text of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain. | |||||
| 5 | IECAT | Inclusion/Exclusion Category | Char | Grouping Qualifier | Used for categorization of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain. | "INCLUSION", "EXCLUSION" | |||||
| 6 | IESCAT | Inclusion/Exclusion Subcategory | Char | Grouping Qualifier | A further categorization of the exception criterion. Can be used to distinguish criteria for a substudy or to categorize major or minor exceptions. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain. | "MAJOR", "MINOR" | |||||
| 7 | TIRL | Inclusion/Exclusion Criterion Rule | Char | Rule | Rule that expresses the criterion in computer-executable form. | ||||||
| 8 | 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. |
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