Validation of ADaM includes the following:
- Random sample of subject data inspected and compared between the SDTM domains and ADaM dataset; ADaM specifications are also inspected
- Checks by the ADaM programmer: log review, code review, requirements/specifications review, spot check review (ad hoc programming/visual checks on ADaM data)
- Programming of ADaM datasets by an independent programmer: Independent programmer programs the ADaM datasets per the requirements/specifications. The QC datasets are compared with the main ADaM datasets via PROC COMPARE
- Pinnacle 21 or similar software: datasets are validated per CDISC and FDA validation rules
All findings are reviewed and resolved.