Note: Not for use with human clinical trials.
Trial Repro Stages describes the unique repro stages in a study, with repro stage description, code (short name), and rules for start and end.
Trial Repro Stages—One Record per Planned Repro Stage
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| # | 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 | A sequence of characters used by the sponsor to uniquely identify the study. | 2-character abbreviation, which must be "TT". | ||||
| 3 | RSTGCD | Repro Stage Code | Char | Topic | Not in human clinical trials | Short name of the repro stage, used for programming and sorting. Maximum 8 characters. | |||||
| 4 | RSTAGE | Description of Repro Stage | Char | Synonym Qualifier | RSTGCD | Not in human clinical trials | The name of the repro stage. | ||||
| 5 | TTSTRL | Rule for Start of Repro Stage | Char | Rule | Not in human clinical trials | Expresses the rule for beginning the repro stage. | |||||
| 6 | TTENRL | Rule for End of Repro Stage | Char | Rule | Not in human clinical trials | Expresses the rule for ending the repro stage. Either TTENRL or TTDUR must be present for each repro stage. | |||||
| 7 | TTDUR | Planned Duration of Repro Stage | Char | ISO 8601 duration | Timing | Not in human clinical trials | Used when the rule for ending the repro stage is applied after a fixed duration. |
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