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Make sure you’re ready for the changes

In 19 days, amended clinical trials regulations come into force across England, Scotland, Wales and Northern Ireland.

The regulations go live on 28 April 2026 and introduce a number of changes to how clinical trials of investigational medicinal products (CTIMPs) are set up and delivered in the UK.

We’ve made some operational updates to help you prepare for the changes. Read on to find out more about the release of our Modification Tool, updates to our CTIMP protocol guidance and template, and the publication of our updated suite of model research agreements.

You can also find the link to the clinical trials regulations webinar we held with the Medicines and Healthcare products Regulatory Agency (MHRA) in March, and read more about preparing for research transparency requirements and transitional arrangements.

Read our guidance

Make sure you’re ready for the changes by reading our guidance which sets out what will change in terms of processes, legal requirements, and expectations for CTIMPs when the regulations come into effect.

We’re also making changes to non-CTIMP clinical trials and other types of research to align with the regulations and to streamline the applications process.

If you have any questions about the HRA’s guidance on clinical trials regulations or non-CTIMPs, please contact our engagement team.

Modification Tool launched

The Modification Tool, an updated version of the Amendment Tool, is now available.

We’ve renamed and updated the tool to reflect the change in terminology from ‘amendment’ to ‘modification’ and the new modification types in the amended clinical trials regulations.

The Modification Tool is available on the Integrated Research Application System (IRAS) for information purposes only so that sponsors and researchers have time to familiarise themselves with the updates. The tool will become fully operational on 28 April 2026 and can be included in modification submissions from this date. 

CTIMP protocol guidance and template

We’ve published an updated version of the protocol guidance and template for use in a CTIMP.

The guidance and template reflects the upcoming changes to the amended clinical trials regulations. We’ve also made some updates to align with the Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR).

The updated version (2.0) should be used from 28 April 2026. The current version (1.2) is available for use until 27 April 2026.

The guidance and template will undergo wider review and improvement over summer 2026, with a new version planned for release later this year.

If you have any feedback on the updated version or suggestions for future improvements, contact our engagement team.

Updated suite of model research agreements

We’ve published the updated suite of commercial and non-commercial site agreements and the commercial chief investigator agreement.

The updates have been made to reflect the amended clinical trials regulations and the associated changes for non-CTIMPs to align with the regulations.

Thank you to everyone who gave feedback on the draft proposals last year. We’ve incorporated your feedback into the updated agreements.

The latest version of the agreements should be used from 28 April 2026.

Countdown to implementation webinar recording now available

More than 2,400 people joined speakers from the HRA and MHRA for our webinar on 12 March, to recap on key points covered in the updated clinical trials regulations and in our guidance, and to hear from our panel of experts.

If you were unable to attend or want to remind yourself of some of the points raised, the webinar recording is now available on the MHRA’s clinical trials hub.

Research transparency requirements and transitional arrangements

New legal research transparency requirements are being introduced as part of the upcoming changes to clinical trials regulations.

Clive Collett, Head of Policy and Engagement at the HRA, has written a blog outlining the new requirements, the transitional arrangements in place for trials depending on their status, and guidance on how to prepare for the changes.

HRA and research news

Interested in finding out more about the HRA and our work? We have a range of different newsletters to suit your interests.

HRA Latest – a monthly newsletter to keep you up-to-date with our latest news and developments

HRA Now – an operational bulletin aimed at those working in and supporting the set up and delivery of research

HRA public involvement newsletter – news and information about public involvement in health and social care

Building better research services newsletter – the latest information on our work to improve the digital services used in the UK to plan, manage and deliver health and social care research

If you would like to find out more about health and social care research and opportunities to get involved in studies, sign up to the National Institute for Health and Care Research (NIHR) newsletters.

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If there’s anything you would like to hear about in future updates, please let us know by emailing communications@hra.nhs.uk