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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
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