Auditing and Monitoring

Monitoring is the act of overseeing the progress of a clinical trial, auditing is a systematic and independent examination of the trial related activities and documents.

Monitoring Services:

  • Investigator-Initiated Clinical Trials
  • Assistance with developing Monitoring Plan
    • Tailored to protocol and risk base assessment
    • Full or Brief monitoring plan
  • Oversee the progress of a clinical trial
  • Source document verification
  • Ensure the study is conducted, reported in accordance with:
    • Protocol
    • SOP’s
    • GCP
    • All applicable regulatory requirements
  • Site visit and/or Remote monitoring
  • Pre-study qualification visit
  • Initiation visit
  • Interim monitoring visits
  • Close-out visits

Auditing Services:

  • Investigator-Initiated Clinical Trials
  • Clinical Registries
  • Assistance with developing Auditing Plan
  • Optional full or brief audit

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Centre for Clinical Research and Education
Address: School of Population Health, Curtin University, Bentley WA 6102