Good Clinical Practice Guide: A Comprehensive Resource for Clinical Trials

The Good Clinical Practice Guide is a new publication that provides detailed insights into the legislation, guidance, and best practices related to conducting clinical trials of medicinal products for human use in the UK. This guide is an essential resource for any individual or organization involved in clinical trials, including commercial and non-commercial sponsors, hosts of clinical trials, contract research organizations, clinical research consultants, and other niche providers.

Authored and produced by the MHRA, this guide offers practical advice on implementing the principles of Good Clinical Practice within the context of the clinical trial regulatory framework in the European Union. It is the only guide on Good Clinical Practice available within Europe that has been produced by a regulatory agency, making it a valuable resource for those conducting clinical trials in the UK and beyond.

This comprehensive guide references European legislation and guidance as well as international standards, ensuring its relevance to organizations conducting trials across Europe and beyond. It covers all aspects of clinical trials, from the initial planning stages to the final reporting of results, and provides detailed information on the ethical and regulatory requirements that must be met.

With 542 pages of detailed information, the Good Clinical Practice Guide is an indispensable tool for anyone involved in clinical trials. It is available in paperback format and can be purchased from the Stationery Office. For more information, visit their website.

ISBN-10: 0117081078

ISBN-13: 978-0117081079

Published by Stationery Office, September 24, 2012

Language: English