Purpose and scope
The UK Regulations, which took effect in May 2004, transposed the EU Clinical Trials Directive (2001/20/EC) into UK law. The Directive requires Member States to harmonise the regulation of all trials in the EU that investigate the safety or efficacy of a medicinal product (including medicinal trials with healthy volunteers, and small scale or pilot studies).
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), protects and promotes 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.
MRC and DH have developed this site to help you understand the Regulations. Our advice only supplements that of MRHA: the MHRA is the authority. More Info…
Clinical trial participants
If you would like to find out more about taking part in a clinical trial, please visit the MRC Clinical Trials Unit website. It explains the different kinds of trials, why and how they are run, and provides answers to questions that people often ask about taking part.
The NHS NeLH web pages also give you general information about how trials work and what to expect if you take part in a trial.
Trialists and research funders increasingly consult and involve patients where their experience can help improve the design and delivery of research for patient benefit. Further information can be found through organisations such as Involve.
Advice
We cannot offer advice on individual trials. If you remain unsure about how to ensure your trial meets the regulatory requirements, please contact the MHRA directly, using their help line. If you require advice on meeting regulatory or governance requirements, the UKCRC Regulatory & Governance Advice Service may be able to help.
Site Management
We shall continue to update and improve this site. If you would like to be notified when new material is added, go to the email updates.
Your feedback will help us improve the site. If you have comments on the content and usability of the site, or can offer material for the site to help other researchers and R&D Managers, please use the Site Feedback form.
An editorial group is managing site improvements. The group will consider your feedback and decide what is relevant and appropriate for the site. It may take several weeks for your comments to be implemented.
We intend to have a major review of the site by June 2005, in response to the evolving regulatory environment and your feedback.
