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 | 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. | Either USUBJID or POOLID must be populated. | ||||
3 | POOLID | Pool Identifier | Char | Identifier | C117053 | A sequence of characters used to uniquely identify a group of subjects that have been pooled together. | If POOLID is entered, POOLDEF records must exist for each subject in the pool and USUBJID must be null. Either USUBJID or POOLID must be populated. | ||||
4 | RSUBJID | Related Subject or Pool Identifier | Char | Identifier | Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. | ||||||
5 | SREL | Subject Relationship | Char | Record Qualifier | Describes the relationship of the subject identified in USUBJID or the pool identified in POOLID to the subject or pool identified in RSUBJID. |
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