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.

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

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Recommended Products

Booklets

Investigators' Guide to Investigator Site Audits
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P02 Good Clinical Practice Auditing - Principles and Practice
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING

Webcasts

Webcast - Where Does Audit End?

eLearning Products

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