Chapter 11. Regulations and Guidelines
Published Online: 29 APR 2009
DOI: 10.1002/9781444311723.ch11
Copyright © 2009 Allan Hackshaw
Book Title
A Concise Guide to Clinical Trials
Additional Information
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
Publication History
- Published Online: 29 APR 2009
- Published Print: 10 APR 2009
ISBN Information
Print ISBN: 9781405167741
Online ISBN: 9781444311723
- Summary
- Chapter
Keywords:
- 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)
Summary
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