SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
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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 "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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