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 updated guide to help monitors prepare for and understand the activities and rationale for auditing clinical investigator sites.

This 2026 edition incorporates significant regulatory developments since the original 2013 publication, including:

• ICH E6(R3) (Jan 2025) and its implementation requirements
• Data integrity expectations from FDA and EMA, including ALCOA+ principles
• Electronic systems and eCRF auditing guidance
• Digital health technologies and remote monitoring considerations
• GDPR and data protection requirements in clinical trial auditing
• Risk-based audit approaches and contemporary sampling strategies.

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. Items for Review - audit checklist
6. Reporting and Follow-up
7. Data Integrity in Auditing
8. Special Audit Considerations
9. References
10. Appendix

Authors

Jamila Joseph and members of the RQA Good Clinical Practice (GCP) Committee.

ISBN

978-1-904610-18-2

Published

First published 2013/2023, Revised 2026