Research Governance

The Medicines for Human Use (Clinical Trials) Regulations 2004 (Statutory Instrument 2004 No. 1031) came into force on 1 May 2004 and implemented the EU Clinical Trials Directive (2001/20/EC) in the UK. 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.

Only clinical trials of Investigational Medicinal Products (IMPs) fall within the scope of the Regulations and Clinical Trials Directive, however all research undertaken in the NHS, should be conducted according to the Department of Health’s Research Governance Framework. This includes the identification of a Sponsor.

There are many resources available on the web to help researchers understand the implications of the new Regulations, including the MRC and Department of Health joint initiative, the Clinical Trials Tool Kit. 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. Processes to be followed during trial set-up and conduct
2. Relevant Documents
3. Useful Links