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In-house based & Contracting CRAs
Initiation visit
- Delegation of activities to study site personnel & GCP training
- Demonstration of study procedures, CRF completion & safety reporting procedures
Monitoring visit
- Checking of Screening/Enrollment log file
- Checking of fulfillment of inclusion/exclusion criteria of participants
- Checking of completion of ICFs, CRFs & safety reporting
- Verification of Source Documents
Close-out visit
- Verification of final enrollment & completion of relevant documentation
- Checking of CRF status & verification of study safety information
- Verification of completeness of site Trial Master File