Subject Repro Stages (not for use with human clinical trials) describes the actual order of repro stages experienced by the subject, together with the start date or start date and time and end date/time for each. Planned repro stages are described in the Trial Design model (see Section 5.1.3.1, Trial Repro Stages). Because actual data does not always follow the plan, the SDTM allows for descriptions of an unplanned repro stage for subjects (SJUPDES).
Subject Repro Stages—One Record per Actual Repro Stage per Subject
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 "SJ". | ||||
| 3 | USUBJID | Unique Subject Identifier | Char | Identifier | C69256 | A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product. | |||||
| 4 | SJSEQ | Sequence Number | Num | Identifier | Not in human clinical trials | Sequence number to ensure uniqueness within the dataset. Should be assigned to be in a consistent chronological order. | |||||
| 5 | 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. | |||||
| 6 | RSTAGE | Description of Repro Stage | Char | Synonym Qualifier | RSTGCD | Not in human clinical trials | The name of the Repro Stage. If RSTGCD has a value of "UNPLAN" then RSTAGE should be null. | ||||
| 7 | SJSTDTC | Start Date/Time of Repro Stage | Char | ISO 8601 datetime or interval | Timing | Not in human clinical trials | Start date or start date and time for a Repro Stage for each subject. | ||||
| 8 | SJENDTC | End Date/Time of Repro Stage | Char | ISO 8601 datetime or interval | Timing | Not in human clinical trials | End date/time for a Repro Stage for each subject. | ||||
| 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 | SJUPDES | Description of Unplanned Repro Stage | Char | Synonym Qualifier | RSTGCD | Not in human clinical trials | Description of what happened to the subject during an unplanned Repro Stage. Used only if RSTGCD has the value of "UNPLAN". |
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