Good Clinical Practice Regulatory Authority Inspections eBooklet

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Since the implementation of the EU Clinical Trial Directive in 2004, there has been a significant increase in the number of regulatory authorities conducting Good Clinical Practice (GCP) inspections in the EU.

This guidance aims to provide helpful advice and tips on handling GCP inspections by regulatory authorities.

Inspections may vary between inspectorates, but the principle remains the same. Everyone wants to succeed and ‘do well’ in inspections and this guide will help you achieve this.

We hope that the expert input from the committee will ensure that this document is a useful and easy-to-read guide, full of practical tips on how to manage GCP inspections.

This document has been produced by Monjit Summy and Dounia Sbai members of the Good Clinical Practice Committee of the Research Quality Association (RQA). Thanks to them and the RQA GCP Committee for committing their time and expertise to author this revision of Good Clinical Practice Regulatory Authority Inspections.

 

Contents

1. Background

2. Inspections

2.1 Inspection notification

2.2 Preparation for the Inspection

2.3 The inspection

2.4 Following on from the Inspection

3. Investigator site inspections

3.1 Investigator Site Inspection Notification

3.2 Preparation for the investigator site inspection

3.3 The investigator site inspection

3.4 Following on from the investigator site inspection

Authors

Monjit Summy and Dounia Sbai and members of the RQA Good Clinical Practice Committee

ISBN

978-1-904610-17-5

Published

2023