Research and Development Forum
Research Governance Documentation and Information Guide
5. CLINICAL TRIALS REGULATIONS
The UK Medicines for Human Use (Clinical Trials) Regulations 2004 implement the EU Clinical Trials Directive in the UK. The main aim of the Directive is to simplify and harmonise the administrative provisions governing clinical trials on medicinal products for human use, by establishing a clear, transparent procedure and creating conditions conducive to the effective co-ordination of such clinical trials in the European Community. Overall, the Directive aims to provide an environment for conducting clinical research that protects participants without hampering the discovery of new essential medicines. ‘The Medicines for Human Use (Clinical Trials) Regulations came into force on 1 May 2004.
a) European Commission and UK Government Documents
Clinical Trials Directive 2001/20/EC
Texts for Directive 2001/20/EC
This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
Medicines for Human Use (Clinical Trials) Regulations 2004
Database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC. This site allows the sponsor to: get a EudraCT number and complete, save as a .xml file on your computer and print a pdf version of the clinical trial application form.
b) The Medicines and Healthcare products Regulatory Agency (MHRA)
MHRA is an Executive Agency of the Department of Health. Its role is to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. The MHRA is the regulatory body responsible for clinical trials authorisation (CTA)
Clinical Trials Directive section
The Clinical Trials Unit is part of the Licensing Division of the Medicines branch of the MHRA. The role of the Unit is to assess applications from sponsors to conduct clinical trials with medicinal products.
of the Medicines for Human Use (Clinical Trials) Regulations 2004
A comprehensive page of links to clinical trials legislation, guidance documents, databases, information from MHRA and other useful sites.
it a Clinical Trial?
c) The Clinical Trials Tool Kit
In July 2004 the MRC and DH agreed to collaborate on a joint project to document best practice in publicly and charitably funded clinical trials of medicines, for the benefit of the trials and R&D management communities and the MHRA. The Clinical Trials Tool Kit brings together and disseminates the work of the Joint Project including legislation, guidance and good practice on the regulations. The information is particularly relevant to all publicly funded research in the NHS and is aimed primarily at investigators, trial managers and NHS R&D staff.
Register to receive email updates covering what’s new on the Clinical Trials Toolkit site
Trials Tool Kit – Route maps
Notes on Good Practice for Research Organisations in the Management of
a Portfolio of Trials (last updated 5 October 2004)
Three documents containing useful information and guidance on research management, risk assessment and management of risk – the principles are useful for research active organisations whatever level of research activity they support.
page last updatedNovember 13, 2008
© NHS R&D Forum 2008