Clinical Trials Toolkit
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 is not imminent, (anticipated to be in place by 2016) and potentially subject to revision, 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.Get Started with the Routemap
05 Jul 2016
A workshop is being held later this year to encourage research into incontinence. The workshop is being developed by a group of medical research charities to provide advice and facilitate discussion for researchers who are...View
06 Apr 2016
A single application for HRA Approval will replace separate applications for governance and legal compliance, for all study types in the NHS led from England from the end of March 2016.This completes the phased roll...View
We would welcome your feedback and suggestions on how we can improve the toolkit. Please help to keep the toolkit up-to-date by reporting any out-of-date content or broken links.Go to form
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The NIHR funds and manages a number of health research programmes, with ongoing funding opportunities. If you would like information on current NIHR calls for proposals, please visit the NIHR website and relevant programme webpages.Find out more