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In-house based & Contracting CRAs
Initiation visit
- Delegation of activities to study site personnel
- Discussion of the scientific aspects of the study
- GCP training
- Demonstration of study procedures
- Demonstration of CRF completion
- Demonstration of 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
- Verification of Source Documents
- Checking of safety reporting
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
