60 Pre-Inspection Preparation
60.1 CRA Pre-Inspection Checklist
60.2 Document Consistency Checks
Verify consistency between: - Source documents - EDC - Monitoring reports - TMF - Correspondence
NoteOncology-Specific Considerations
- Imaging data and tumor assessments often reviewed
- Dose modifications scrutinized
NoteVaccine Trial Considerations
- Specimen collection timing, handling, and laboratory documentation are often reviewed to ensure validity of immunogenicity endpoints.
- Vaccine accountability, storage conditions, and temperature monitoring records may receive focused inspection review.
- Documentation supporting vaccination timing and follow-up visit windows should be complete and consistent with protocol requirements.