SDTM v2.0 Metadata Check for Class and Dataset Specification Table 1.4.0
Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. 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 Tox Assay ID |
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 SDTM 2.0: | 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 |
LVLDESC |
Reference ID Generation Level Description | Char | Variable Qualifier | LEVEL |
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 |
Metadata Checks Findings
SDTM & Related IG Metadata Check User Macros FAQ
- Content: Variable Name USUBJIDGNTXAID is longer than 8 characters
- Content: For variable USUBJIDGNTXAID, variable label Unique Subject IdentifierGenetic Tox Assay ID is longer than 40 characters
- Content: For variable LEVEL, variable label Reference ID Generation LevelSDTM 2.0: Specimen Level is longer than 40 characters
- Content: Variable Name SPECLVLDESC is longer than 8 characters
- Content: For variable SPECLVLDESC, variable label Specimen TypeReference ID Generation Level Description is longer than 40 characters
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