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

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