Global Guideline for GCP Audit eBooklet

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Information

The Global Guideline for Good Clinical Practice (GCP) Audit was originally developed by RQA, SQA, and JSQA and was issued in 2014. At that time according to definition, auditing was a systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, written procedures, GCP, and the applicable regulatory requirement(s).

In 2026, the guideline was revised by JSQA/RQA/SQA GCP Committees to reflect changes in industry best practices, computerised systems, information technologies, regulations, and ICH E6 (R3) Guideline for Good Clinical Practice. Specifically, ICH E6 (R3) describes the need to perform audits using a risk-based approach, focusing on the use of risk identification to prioritise areas of high risk, e.g. informed consent, trial endpoints, and service provider oversight. Audits should be conducted in a manner that is proportionate to the risks associated with the conduct of the trial. Data Governance requirements to ensure reliable results and data integrity are also included in ICH E6 (R3), and should be considered in audit planning and conduct, especially in the areas of appropriate management of data integrity, traceability and security.

Contents

1. Risk Based Approach for Audit Planning
2. Process & System Audits
3. Service Provider Audits
4. Investigator Site Audits
5. Auditing Decentralised Aspects of Clinical Trials
6. Computerised System Audits
7. Trial Master File Audits
8. Ethics Committee Audits
9. Clinical Documentation Audits
10. Remote Audits
11. Corrective and Preventive Action

Authors

Japanese Society of Quality Assurance (JSQA), Research Quality Association (RQA) and the Society of Quality Assurance (SQA). 

This guideline and it’s appendices were developed by:

• Bernadette Bowen, SQA
• Rosemarie Corrigan, RQA
• Klaus Goodwin, SQA
• Takahiro Hanai, JSQA
• Hiromichi Ishikawa, JSQA
• Julie Kelly, RQA
• Leslie Paul, SQA
• Mark Poulton, RQA
• Joseph Turton, RQA

Special thanks also goes to the RQA, JSQA and SQA GCP Committees for their contributions to the guideline.

Published

2026