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 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "TP". | ||||
| 3 | RPATHCD | Planned Repro Path Code | Char | Topic | Not in human clinical trials | C170503 | A short sequence of characters that represents the planned reproductive path to which the subject was assigned. | Limited to 20 characters. Should be populated in Demographics when repro paths have been defined in this domain. | |||
| 4 | RPATH | Description of Planned Repro Path | Char | Synonym Qualifier | RPATHCD | Not in human clinical trials | Name of the planned repro path. | ||||
| 5 | TPSTGORD | Order of Repro Stage within Repro Path | Num | Timing | Not in human clinical trials | Number that gives the planned order of the repro stage within the repro path. | |||||
| 6 | 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. The values of RSTGCD used in the Trial Paths dataset must match values for the same repro stage in the Trial Stages dataset. | |||||
| 7 | RSTAGE | Description of Repro Stage | Char | Synonym Qualifier | RSTGCD | Not in human clinical trials | The name of the repro stage. | ||||
| 8 | TPBRANCH | Branch | Char | Rule | Not in human clinical trials | Conditions subjects meet, occurring at the end of a repro stage, which cause a repro path to branch off from another repro path. | |||||
| 9 | RPHASE | Repro Phase | Char | Timing | Not in human clinical trials | Name of the reproductive phase with which this repro stage of the repro path is associated. | |||||
| 10 | RPRFDY | Repro Phase Start Reference Day | Num | Timing | Not in human clinical trials | Sponsor protocol-defined first day of repro phase. Should be zero or 1. |
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