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 RoutemapLatest news
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Interpretation of the definition of receipt of Valid Research Application for NIHR contract metrics on trial initiation (the 70 day benchmark)
21 Jul 2014The 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...
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Posting of clinical trial summary results in EudraCT to become mandatory for sponsors
25 Jun 2014It will become mandatory for sponsors to post clinical trial summary results in the European Clinical Trials Database (EudraCT) as of 21 July 2014. This corresponds with the launch of the final iteration of EudraCT which will...
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New Clinical Trials Regulation will streamline the authorisation process for Clinical Trials
23 Jun 2014A new regulation, which will replace the existing EU Clinical Trials Directive, will streamline the authorisation process and harmonise requirements for clinical trials in Europe. The Clinical Trials Regulation was published in the Official Journal...
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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.
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Sign upThe 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.
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