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Published by the World Health Organization, Geneva, 2005, pp 125 (softcover) + CD. ISBN 92‐4‐159392
Ever thought good clinical practice (GCP) dull? Ever felt abbreviated out? Well, I'd like to report that the WHO's Handbook for good clinical practice (GCP): guidelines for implementation is an antidote to the mind‐boggling stream of acronyms bandied about in research and development departments throughout the world, and that it provides an interesting and amusing narrative on the current minefield that constitutes Research Governance…
Well, as the title might suggest, it was a bit of a long shot.
Research and development managers, finance departments, data protection officers and ethics committees now form a formidable team apparently dedicated to snuffing out the life of a research idea at conception. They have had to become familiar with the requirements of GCP, mandatory in this country since March 2004. The research community is slowly catching up. Transforming research from its cottage industry status, where anyone can have a go, has been a traumatic experience for many researchers. It remains so in some cases, and “own account” studies on investigational medicinal product are becoming a rarity. GCP, of course, applies to any study involving human subjects, not just to drug or device trials. The business of research governance is now bedded down in many trusts, especially the larger ones, and is operating reasonably smoothly. It is easy to forget, however, especially when attempting to get an investigational medicinal product study off the ground, that GCP regulations are actually intended to improve the quality of research and the safety of patients. In most cases, this is exactly what they have achieved. The handbook acts as a useful reminder of the essential philosophy underpinning the bureaucracy.
It provides a concise and clear description of the 14 principles underlying GCP as well as guidance on their implementation in practice. The roles and responsibilities of the various stakeholders in the research process are also described. There are many sources used, the eight most important of which are on an accompanying CD. It follows the research process through the development of the protocol and standard operating procedures, support systems and trial‐related documentation, selection of trial sites, ethics approval, through to data management and reporting. Each step in the process has relevant GCP principles, which need to be borne in mind.
Naturally, the handbook is written for an international audience and will only ever act as useful background to your local GCP training. Nevertheless, it is background that I'd recommend to serious triallists and health services researchers.