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The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials.
The Toolkit is primarily focused on Clinical Trials of Investigational Medicinal Products (CTIMPs) and the regulatory environment and requirements associated with these. However researchers and R&D staff working on trials in other areas will also find useful information and guidance of relevance to the wider trials environment.
Please note the Toolkit describes the requirements for Clinical Trials of Investigational Medicinal Products (CTIMPs) brought about by the introduction of the European Commission Directive 2001/20/EC. A proposal to repeal Directive 2001/20/EC and replace it with a European Regulation has been published. As this new Regulation has not been finalised, its content is not widely discussed within this Toolkit at this stage. However, the site will consider the implications of any confirmed change in due course and provide updated information and guidance as agreed.
Latest Clinical Trials Toolkit news
The James Lind Alliance is recruiting advisers to join the team
The James Lind Alliance (JLA) would like to recruit JLA Advisers to join the team. They are looking for independent consultants who will contract with the University of Southampton to support and facilitate JLA Priority Setting Partnerships.
Pilot to test a combined MHRA-REC approval process
The HRA and MHRA are exploring ways to streamline approval and ongoing management of CTIMPs through a combined ways of working pilot.
Questions about retaining people in clinical trials?
A new survey is now open across the UK and Ireland about retention to randomised trials. The survey is aimed at people involved in running trials and anyone who has been invited to take part in one.
