| # | 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
GNTXAID | Unique Subject Identifier
Genetic Tox Toxicology Assay ID | Char |
| IdentifierC69256 |
|
|
| A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product.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 | C82531 |
|
|
| A sequence of characters used to uniquely identify a source of information. |
|
|
| 5 | PARENT | Parent Reference ID SDTM 2.0:
Parent | Char |
| Identifier |
|
|
| The identifier for the immediate progenitor of a source of information. Batch 2: The identifier for the immediate progenitor of the source of information. | Identifies the REFID of the parent. |
|
| 6 | LEVEL | Reference ID Generation Level SDTM 2.0: Specimen Level | Num |
| Variable Qualifier | REFID |
|
| The generation number of the information source in relation to the first generation of the source of information.Batch 2: The generation number of a biospecimen in relation to the collected biospecimen that is considered the first generation. | Identifies the level number of the reference ID. |
|
| 7 | SPEC
LVLDESCSpecimen Type | Reference ID Generation Level Description | Char |
| Variable Qualifier | LEVEL | C70713 | The type of sample material taken from a biological entity. |
|
| 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 |