The Good Clinical Practice Guide

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The Good Clinical Practice Guide

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The Good Clinical Practice Guide

ISBN: 9780117081079
Author MHRA
Binding: Paperback
Publisher: TSO
Publication Date: September 2012

The Good Clinical Practice Guide is a brand new publication covering the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK.

Detailed and authoritative, this guide will provide practical advice about implementing the principles of Good Clinical Practice within the context of the clinical trial regulatory framework in the European Union.

Written and produced by the MHRA, this is the only guide on Good Clinical Practice available within Europe which has been produced by a regulatory agency.

The Good Clinical Practice Guide is aimed at any individual and/or organisation involved in conducting clinical trials with medicines in the UK, including both commercial and non-commercial sponsors and hosts of clinical trials, as well as contract research organisations, clinical research consultants and other niche providers.

The guide references European legislation and guidance as well as international standards, so will also be relevant to organisations conducting trials across Europe and beyond.


This is an impressive and detailed overview of clinical trials that will add value to all working in this field on a global basis, not just in the UK. The consistency of style throughout is surprising and welcome. Alec Deighton, Representative of the Association of Clinical Research Organizations (ACRO)

Content of Chapters

1. Sponsor Oversight

2. Clinical Trial Authorisations

3. Ethical Review

4. Key Trial Documentation

5. Pharmacovigilance for Clinical Trials

6. Investigational Medicinal Products

7. Monitoring

8. Data Management

9. Statistics

10. Trial Master File and Archiving

11. Investigator Sites

12. Phase I Clinical Trials

13. Clinical Trial Samples - Analysis and Evaluation

14. Quality Systems

Annex 1: Introduction to GCP Inspections

Annex 2: Relevant legislation and guidance

Annex 3: Advanced Therapy Investigational Medicinal Product Trials

Annex 4: Considerations for the use of electronic systems in clinical trial management

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