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 Choices 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.
Site Management
The National Institute for Health Research (NIHR) has now taken over responsibility for the Clinical Trials Toolkit, as the lead organisation for funding clinical trials. Over the coming months, on behalf of the NIHR, the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) will be updating the information on this website to reflect changes in best practice and current requirements in conducting clinical trials.
It is intended that a new Clinical Trials Toolkit and website will be launched in summer 2012. If you would like to register your interest in taking part in ongoing user testing, would like to receive occasional email updates and notification of the launch of the new toolkit, or have any queries please send an email to ct-toolkit@southampton.ac.uk.
