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| Root Variable Name | Variable Label | Variable C-code | Definition | Notes | CDASH | General Observation Class | Special Purpose | Trial Design | Study Reference | Relationship | Associated Persons |
|---|---|---|---|---|---|---|---|---|---|---|---|
| --CAT1 | Category TI: Inclusion/Exclusion Category | C25372 | A grouping or classification of the topic of the finding, event, or intervention. | TI: Used for categorization of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain. | Findings-General Interventions-General Events-General | TI | |||||
| --EVAL | Evaluator | C51824 | The role of the person(s) providing an evaluation, appraisal, or interpretation. | Used only for results that are subjective (e.g., assigned by a person or a group). Used to describe the originator of the comment. | Findings-General | CO | |||||
| --EVALID | Evaluator Identifier | C117043 | A sequence of characters used to uniquely identify the evaluator(s). | Used to distinguish multiple evaluators with the same role recorded in --EVAL. | Findings-General | CO | |||||
| --REFID | Reference ID | C82531 | A sequence of characters used to uniquely identify a source of information. | All Classes-General | RELSPEC | ||||||
| RPATHCD | Planned Repro Path Code | C170503 | A short sequence of characters that represents the planned sequence of reproductive stages within each reproductive phase. | DM: Limited to 20 characters. TP: Limited to 20 characters. Should be populated in Demographics when repro paths have been defined in this domain. | DM | TP | |||||
| --SCAT1 | Subcategory TI: Inclusion/Exclusion Subcategory | C25692 | A further grouping or classification of the category for the topic of the finding, event, or intervention. | The category is in --CAT. TI: 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. | Findings-General Interventions-General Events-General | TI | |||||
| SPDEVID | Sponsor Device Identifier | C117060 | A sequence of characters used by the sponsor to uniquely identify a specific device. | DI: Sponsor-defined identifier for the device. DR: Sponsor-defined identifier for the device. It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers) as defined in DI. | All Classes-General | DI | DR | ||||
| --SPEC2 | Specimen Material Type RELSPEC: Specimen Type | C70713 | The type of sample material taken from a biological entity. | Findings-General | RELSPEC | ||||||
| TAETORD3 | Planned Order of Element Within Arm | C83438 | An assigned numeric identifier that gives the planned order of the element within the trial arm of the study. | All Classes-General | TA | ||||||
| --TEST1 | Name of Measurement, Test, or Exam TI: Inclusion/Exclusion Criterion | C82503 | The standardized or dictionary-derived name of the measurement, test, or examination. | TI: Full text of the inclusion or exclusion criterion. The prefix "IE" (rather than TI) is used to ensure consistency with the IE domain. | Findings-General | TI | |||||
| --TESTCD1 | Short Name of Measurement, Test, or Exam TI: Inclusion/Exclusion Criterion Short Name | C82503 | The standardized or dictionary-derived short sequence of characters used to represent the measurement, test, or examination. | Used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters. TI: 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. | Findings-General | TI |
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