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.

Contents

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

Authors

RQA GCP Committee

ISBN

978-1-904610-18-2

Published

Published 2013, Revised 2023