Research Governance

The EU Directive on Clinical Trials became UK law on 1 May 2004. The aims of the Directive are:

• To protect the rights, safety and well being of trial participants
• To simplify and harmonise the administrative provisions governing clinical trials
• To establish a transparent procedure that will harmonise trial conduct in the EU and ensure the credibility of results.

The Directive only applies to trials involving an investigational medicinal product. All trials should follow the NHS Research Governance Framework. This includes the identification of a Sponsor.

There are many resources available on the web to help trialists understand the implications of the Directive. We have developed the following document, designed to be used online, to help to guide you to the relevant documents and to make you aware of the information available. NCRN aims to keep this document up to date. If you are aware of other links that should be included, please let us know (enquiries@ncrn.org.uk).

The guidance document may be downloaded from here and the information provided is grouped into the following sections:

1. Documents relating to the EU Directive for Clinical Trials
2. Processes to be followed during trial set-up and conduct
3. Links to relevant web sites

Also, the MRC and DoH have developed a Clinical Trials Tool Kit to help academic trialsists navigate the Directive and its requirements.