Not for use outside of human clinical trials.
| Metadataspec |
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| highlight | true | keys | Notes;Core;Description |
|---|
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| shareqc_sdtmig34sdtm4tig10_ds |
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| Class | Trial Design |
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| Domain | TI |
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| | Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
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| 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 |
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1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses. |