Chapter 7. Conduct of Clinical Trials: Good Clinical Practice

  1. John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
  2. John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
  1. Roger A Yates

Published Online: 25 OCT 2007

DOI: 10.1002/9780470987391.ch7

Book Title

The Textbook of Pharmaceutical Medicine, Fifth Edition

The Textbook of Pharmaceutical Medicine, Fifth Edition

Additional Information

How to Cite

Yates, R. A. (2007) Conduct of Clinical Trials: Good Clinical Practice, in The Textbook of Pharmaceutical Medicine, Fifth Edition (eds J. P. Griffin and J. O'Grady), Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470987391.ch7

Editor Information

  1. 1

    Director, Asklepieion Consultancy Ltd., Visiting Professor, University of Surrey Postgraduate Medical School, Former Director, Association of the British Pharmaceutical Industry, London, Formerly Professional Head of the Medicines Division, DHSS, London

  2. 2

    Visiting Professor of Clinical Pharmacology, University of London

Publication History

  1. Published Online: 25 OCT 2007
  2. Published Print: 15 DEC 2005

ISBN Information

Print ISBN: 9780727918406

Online ISBN: 9780470987391

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CHAPTER TOOLS

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Keywords:

  • drug development;
  • clinical trials;
  • good clinical practice;
  • informed consent forms;
  • code of federal regulations

Summary

This chapter contains sections titled:

  • Introduction

  • Good Clinical Practice

  • Preparation of Documentation for the Clinical Trial

  • The Study Drug and its Documents

  • The Running of the Clinical Trial

  • Preparation of the Clinical Report

  • Quality Management

  • Conclusion

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