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
01 May 2013
The NIHR is launching a new campaign to empower patients and encourage engagement in clinical research – and we are calling on all NIHR-funded researchers to take part.The ”It’s OK to ask” campaign launches...View
27 Mar 2013
The Health Research Authority (HRA), the organisation which protects and promotes the interests of patients and the public in health research, has issued its first newsletter. The newsletter is available to download here. This newsletter...View
26 Mar 2013
The General Medical Council (GMC) has published supplementary guidance which sets out the good practice principles that doctors are expected to understand and follow if they are involved in research. Among other requirements, this guidance...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 Please help to keep the toolkit up-to-date by reporting any out-of-date content or broken links.Go to form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