Chapter 11. Regulations and Guidelines

  1. Allan Hackshaw Deputy Director1,2

Published Online: 29 APR 2009

DOI: 10.1002/9781444311723.ch11

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials

How to Cite

Hackshaw, A. (2009) Regulations and Guidelines, in A Concise Guide to Clinical Trials, Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444311723.ch11

Author Information

  1. 1

    Cancer Research, UK

  2. 2

    UCL Cancer Trials Centre, UK

Publication History

  1. Published Online: 29 APR 2009
  2. Published Print: 10 APR 2009

ISBN Information

Print ISBN: 9781405167741

Online ISBN: 9781444311723



  • international conference on harmonisation (ICH);
  • good clinical practice (GCP);
  • written information – the patient information;
  • non-negligent harm – physical or emotional injury or death;
  • institutional review board (IRB);
  • ministry of health, labour and welfare (MHLW)


This chapter contains sections titled:

  • The need for regulations

  • International Conference on Harmonisation (ICH)

  • Good Clinical Practice (GCP) and the EU Clinical Trials Directives

  • Independent audit or inspection of clinical trials

  • Regulations surrounding research in special populations

  • Non-EU countries

  • Summary

  • References