Monitoring

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