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For tabulation datasets, conformance to standards is minimally ensured by:
| Metadataspec |
|---|
| Num | Conformance | Implementation |
|---|
| 1 | Representing all collected, assigned, and relevant derived data in applicable datasets. | All data generated per scientific and regulatory requirements are included in the standardized tabulation dataset. | | 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 | Following conventions for variable names. | The names of variables are standardized per tabulation guidance for all variables in the dataset. | | 7 | Following conventions for variable labels. | The labels for variables are standardized per tabulation guidance for all variables in the dataset. | | 9 |
| Conforming to guidance in CDISC Notes column and general and domain-specific assumptions. |
|
|
| | 8 | Following Core designations. | All Required and Expected tabulation variables are included as columns in the dataset. Required tabulation variables are populated for all records in the dataset. |
|
For analysis datasets, conformance to standards is minimally ensured by:
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