SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied. Make sure all Confluence WIKI macros e.g., JIRA, Status, are removed prior to publication. 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 | GNTXAID | Genetic Toxicology Assay ID | Char | Identifier | NEW A short sequence of characters that uniquely identifies a genetic toxicology assay within a study. | ||||||
| 3 | SETCD | Trial Set Code | Char | Identifier | The short sequence of characters used to represent the trial set. | The value "ALL" is used to indicate all trial sets within the assay. | |||||
| 4 | REFID | Reference ID | Char | Identifier | A sequence of characters used to uniquely identify a source of information. | ||||||
| 5 | PARENT | Parent Reference ID | Char | Identifier | The identifier for the immediate progenitor of a source of information. | Identifies the REFID of the parent. | |||||
| 6 | LEVEL | Reference ID Generation Level | Num | Variable Qualifier | REFID | The generation number of the information source in relation to the first generation of the source of information. | Identifies the level number of the reference ID. | ||||
| 7 | LVLDESC | Reference ID Level Description | Char | Variable Qualifier | LEVEL | NEW A description of the generation number of the information source in relation to the first generation of the source of information. | ASSAY, TRIAL SET, EXPERIMENTAL UNIT, OBSERVATIONAL UNIT |
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