Trial Elements describes the periods of times through which subjects pass in the course of a trial. The domain is identified by the domain code "TE".
Trial Elements—One Record per Trial Element
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 "TE". | ||||
| 3 | ETCD | Element Code | Char | Topic | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name. | ||||||
| 4 | ELEMENT | Description of Element | Char | Synonym Qualifier | ETCD | The name of the element. | |||||
| 5 | TESTRL | Rule for Start of Element | Char | Rule | Expresses the rule for beginning the element. | ||||||
| 6 | TEENRL | Rule for End of Element | Char | Rule | Expresses the rule for ending the element. Either TEENRL or TEDUR must be present for each element. | ||||||
| 7 | TEDUR | Planned Duration of Element | Char | ISO 8601 duration | Timing | Used when the rule for ending the element is applied after a fixed duration. |
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