| 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 datasets. |
| 2 | Following guidance conventions for dataset naming. | The dataset name is standardized per domain specifications and per naming conventions and per controlled terminology where applicable. |
| 3 | Following guidance for dataset record structure. | The dataset name and record structure are standardized per structure is aligned with the structure specified per the applicable domain specificationsspecification. |
| 3 | Following domain specifications in this guide wherever applicable. | The dataset |
| 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. |