A Monitor’s Guide to Investigator Site Audits Booklet

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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.

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
8. Why are Audits Performed?
9. Further Information
10. References
11. Appendix

Authors

RQA GCP Committee

ISBN

978-1-904610-18-2

Published

December 2008
Reprinted January 2013

Discount Information

Discounts are available for bulk orders. Please enter one of the following discount codes:

• BOOK10 for orders of 10 - 19 copies - 25% discount
• BOOK20 for orders of 20 - 49 copies - 33% discount
• BOOK50 for orders over 50 copies - 50% discount

This discount is available for both a block of one title or a combination of titles in hardback.

If ordering 50 or more books for delivery to outside the UK, please contact the RQA office as we will need to calculate the delivery cost for you.

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