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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DH approves HRA business plan to deliver a single approval system for all health research studies in England
01 Apr 2014On 31 March 2014, Earl Howe, Parliamentary Under-Secretary of State for Quality, announced funding for the Health Research Authority (HRA) to deliver a single approval system for all health research studies in England.HRA Assessment and Approval...
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Questions that need answering when designing clinical trials – new guidance from the HRA
21 Mar 2014The Health Research Authority has published useful guidance to clarify which questions researchers, sponsors, peer reviewers, and ethics committees should ask when planning or reviewing clinical studies.The HRA Guidance poses five questions:1. Is there...
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Tight glycaemic control cuts paediatric intensive care stays
14 Jan 2014Research, funded by the NIHR HTA programme, suggests that the length of hospital stay for critically ill children could be reduced by changing the way paediatric intensive care units (PICU) commonly control blood sugar levels...
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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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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.
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