Welcome to the Clinical Trials Tool Kit

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.  The Clinical Trials Toolkit was developed in 2004 in a joint project between the Department of Health and the Medical Research Council to document best practice in publicly and charitably-funded clinical trials of medicines.  For further details about the origins of the toolkit, please visit the toolkit origins page.

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.  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.  Further info…

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.  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.  Your email address will only be used to inform you of news relevant to the Clinical Trials Toolkit.  If your details are registered with NETSCC for other purposes, they will not be affected by signing-up for alerts about the toolkit.