SDTM v2.0 Metadata Check for Class and Dataset Specification Table 1.4.0
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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 | 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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