| # | 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". |
|