About this site

The Clinical Trials Toolkit was initially developed and launched in 2004 by the MRC and the Department of Health and Social Care to help clinical trialists and R&D managers understand the regulations and requirements for conducting trials. As the lead organisation for funding clinical trials, the NIHR became responsible for the Clinical Trials Toolkit in 2012.

The site content is regularly updated in collaboration with relevant stakeholders, and the current version reflects the new Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which came into force on 28 April 2026.

The site addresses the requirements of the current UK regulations. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Research Authority (HRA) protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. 

If you remain unsure about how to ensure your trial meets the regulatory requirements, please contact the MHRA or HRA directly, using the contact details below:

MHRA Clinical Trial Helpline 

Tel: 020 3080 6456
Email: clintrialhelpline@mhra.gov.uk

HRA general enquiries

Tel: 0207 104 8000
Email: contact@hra.nhs.uk

Acknowledgements

The 2026 revision of the Clinical Trials Toolkit content was led by Dr Tanya Symons (T Symons Associates Pty Ltd) and coordinated by the NIHR.

The NIHR would like to thank all those who contributed both time and expertise to the revision work.