Good Clinical Practice Regulatory Authority Inspections Booklet

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With the implementation of the EU Clinical Trial Directive in 2004, there has been a significant increase in the number of Regulatory Authority GCP inspections in the EU.

With twenty-seven national authorities within the EU and other authorities such as the US FDA actively inspecting, it has become a very busy time for those involved in clinical development.

This guidance book aims to provide helpful advice and tips on the process of Sponsor and Investigator Site GCP inspections by Regulatory Authorities.

The process of the inspection may vary between inspectorates, but the principle remains the same. Everyone wants to succeed and "do well" in inspections, and this guide will help us to achieve this.

Contents

1. Background
2. Sponsor Inspections
3. Investigator Site Inspections
   

Authors

Bruce Seymour-Taylor and members of the RQA Good Clinical Practice Committee

ISBN

978-1-904610-17-5

Published

December 2012

Discount Information

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

• 89BOOK10 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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