Welcome to the Clinical Trials Tool Kit

On this site you will find practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations implement the EU Clinical Trials Directive in the UK. In light of amendments to these regulations in 2006, we are currently working to update this site.  This will be finalised following publication of the specific modality for non-commercial trials. 

The site has been developed primarily for clinical trialists and R&D managers working in the academic sector, but will also be of use to other health professionals.

To help you to navigate through the Regulations, much of the information is organised within three Route Maps.  Your feedback on the content and presentation will help us improve the site.

Even if your research falls outside the Regulations, you could still find the Route Maps useful.   Much of the advice they contain is relevant to clinical trials and research more generally.

The site has been developed by the UK Medical Research Council and Department of Health for use in all publicly funded academic trials. Further info…