Built with data management, not handed to them
Review criteria are developed jointly with data management so the DRP reflects both operational and statistical review needs from the start.
What's included
What goes into the DRP input
- Statistical review criteria mapped to the analysis populations and key endpoints defined in the SAP
- Outlier, range, and cross-form consistency logic specified for inclusion in the Data Review Plan
- Review criteria coordinated with edit check specifications so the two stay consistent rather than duplicating or conflicting
- Timing and frequency of statistical listing review defined ahead of the first data review cycle
- Sign-off on the statistical sections of the DRP before it's finalized with data management
Carried through to conduct
The criteria specified here drive the statistical data review and listings review performed throughout the study.