What's included

What reviewers look for

• Cross-domain consistency checks that programmed edit checks aren't built to catch — dates, dosing, and visit logic reviewed together
• Clinical judgment review of values that fall within programmed limits but look implausible in context
• Source-data consistency spot-checks against the protocol and CRF completion guidelines
• Review scope, frequency, and sign-off requirements run against the agreed Data Review Plan
• Findings logged as queries and tracked through resolution rather than noted and left open