Note: Not for use with human clinical trials.
Trial Repro Paths describes each planned repro path in a repro study, with the ordered sequence of repro stages that comprise each repro path, as well as specification of repro phase and reference start day of the repro phase applicable to the repro stage within the repro path.
Trial Repro Paths—One Record per Planned Repro Stage per Repro Path
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 | 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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