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Good Clinical Practice Regulatory Authority Inspections

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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


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