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.

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Latest news

  • Guidance on funding excess treatment costs

    24 Nov 2015

    NHS England has published guidance on funding excess treatment costs to help clarify the rules and expectations regarding this.The guidance has been produced in consultation with the Department of Health and other key stakeholders, and...

  • HRA issues advance applicant guidance for third phase of HRA Approval

    09 Nov 2015

    The schedules go live for cohort three of HRA Approval is 30 November 2015, This will see the scheme extended further to a broad range of studies other than clinical trials or investigations in secondary...

  • CT Toolkit - updated 'Trial Supplies' guide

    21 Sep 2015

    An updated version of the CT Toolkit Trial Supplies Guide is now available via the Trial Supplies station. This guidance has been prepared to codify good practice in publicly-funded clinical trials. It provides an introduction...

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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 Please help to keep the toolkit up-to-date by reporting any out-of-date content or broken links.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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