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. | |||||
| 3 | REFID | Reference ID | Char | Identifier | C82531 | A sequence of characters used to uniquely identify a source of information. | |||||
| 4 | SPEC | Specimen Type | Char | Variable Qualifier | REFID | C70713 | The type of sample material taken from a biological entity. | ||||
| 5 | PARENT | Specimen Parent | Char | Identifier | Identifies the REFID of the parent of a specimen to support tracking its genealogy. | ||||||
| 6 | LEVEL | Specimen Level | Num | Variable Qualifier | REFID | Identifies the generation number of the sample where the collected sample is considered the first generation. |
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