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
11 Sep 2014
The European Commission published the EU Clinical Trials Regulation on 27 May 2014. Tanya Symons, the GCP expert who led the re-development of the Clinical Trials Toolkit in 2012, talks about the new Regulation that will replace Directive 2001/20/...View
20 Aug 2014
The Wellcome Trust has commissioned an independent study to examine the research potential of enhanced access to clinical trial datasets. The study team is keen to consult key stakeholders (academic, clinical, industrial, regulatory and...View
Interpretation of the definition of receipt of Valid Research Application for NIHR contract metrics on trial initiation (the 70 day benchmark)21 Jul 2014
The National Institute for Health Research has produced a document interpreting the definition of receipt of Valid Research Application for studies included in the 70 day benchmark (i.e. clinical trials). NHS providers who are subject...View
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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