Good Clinical Practice Guide
Author: Medicines and Healthcare products Regulatory Agency
Publisher: TSO (The Stationery Office)
The Good Clinical Practice Guide covers the legislation, guidance
and good practice that relates to the conduct of clinical trials of medicinal
products for human use in the UK.
Detailed and authoritative, this guide provides practical advice about implementing the principles of Good Clinical Practice within the context of the clinical trial regulatory framework in the European Union.
Written and produced by the MHRA, this is the only guide on Good Clinical Practice available within Europe which has been produced by a regulatory agency.
This title is aimed at any individual and/or organisation involved in conducting clinical trials with medicines in the UK, including both commercial and non-commercial sponsors and hosts of clinical trials, as well as contract research organisations, clinical research consultants and other niche providers.
The guide references European legislation and guidance as well as international standards, so will also be relevant to organisations conducting trials across Europe and beyond.