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| Metadataspec |
|---|
| Num | Conformance | Implementation |
|---|
| 1 | Representing of all collected, assigned, and relevant derived data in applicable datasets. | All data generated as part of documentation (Protocol?), collected as part of study conduct | | 2 | - Following the complete metadata structure for data domains
|
| | 3 | - Following SDTMIG domain models wherever applicable
|
| | 4 |
| - Using specified standard domain names and prefixes per controlled terminology where applicable
| | 5 |
| - Following SDTM-specified controlled terminology and format guidelines for variables, when provided
| | 6 |
| - Using specified standard variable names
| | 7 |
| - Using specified standard variable labels
| | 8 |
| - Including all Required and Expected variables as columns in standard domains, and ensuring that all Required variables are populated
| | 9 |
| Conforming to guidance in CDISC Notes column and general and domain-specific assumptions. |
|
For analysis datasets, conformance to standards is minimally ensured by:
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