| Num | Conformance | Implementation |
|---|
| 1 | Representing 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 Following conventions for variable names. | 7 | - Using specified standard variable labels
| The names of variables are standardized per tabulation guidance for all variables in a dataset. |
| 7 | Following conventions for variable labels. | The labels for variables are standardized per tabulation guidance for all variables in a dataset. |
| 8 | Following 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. |