Analysis-driven, not just database-driven
Checks are prioritized by what matters to the SAP's endpoints, working alongside data management's edit check programming.
What's included
What goes into the edit check input
- Draft edit check specification reviewed against the endpoints and analysis populations defined in the SAP
- Range, consistency, and cross-form logic proposed for fields that feed key efficacy and safety analyses
- Input coordinated with DRP statistical review criteria so edit checks and manual listing review don't overlap or leave gaps
- Recommendations documented for the programming team building against the edit check specification
- Follow-up review once checks are programmed, to confirm the logic matches what was specified
One team across the database and the analysis
The same biostatisticians who write the SAP review the edit check logic, so there's no gap between what's collected and what's analyzed.