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A Monitor’s Guide to Investigator Site Audits

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The RQA is committed to the conduct of the highest quality clinical research. As part of that commitment, and for compliance with Good Clinical Practice (GCP) requirements, RQA has developed this guide to help monitors prepare and understand the activities and rationale for auditing 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
  8. Why are Audits Performed?
  9. Further Information
  10. References
  11. Appendix


RQA GCP Committee




December 2008
Reprinted January 2013

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Introduction to Good Clinical Practice (GCP) elearning
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Introduction to the Audit Process elearning


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