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A Monitor’s Guide to Investigator Site Audits eBooklet

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The Research Quality Association (RQA) is committed to the conduct of the highest quality clinical research. As part of that commitment and to aid compliance with Good Clinical Practice (GCP) requirements, the RQA has developed this guide to help monitors prepare and understand the activities and rationale for auditing clinical investigator sites.


  1. How are Investigator Sites Selected for Audit?
  2. When are Sites Audited?
  3. Why are Audits Performed?
  4. What is the Audit Procedure?
  5. Reporting and Follow up
  6. Investigator Letters
  7. Audit Certificates (if applicable)
  8. Why are Audits Performed?
  9. Further Information
  10. References
  11. Appendix


RQA GCP Committee




Published 2013, Revised 2023


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