Registering research transparency requirements for non-CTIMPs

The changes bring the registration rules for these types of studies in line with new legal research transparency requirements for clinical trials of investigational medicinal products (CTIMPs).

This means that transparency requirements will be applied more consistently across all UK trials, making the process simpler for researchers and sponsors.

Non-CTIMP clinical trials test the safety and effectiveness of patient interventions such as medical devices, surgical techniques, public health measures and behavioural therapies. Unlike CTIMPs, they do not investigate the safety and efficacy of a medicinal product.

It is a condition of a Research Ethics Committee (REC) favourable opinion that a clinical trial is registered, and it is expected that research sponsors make information about their trials publicly available.

This guidance sets out the registration requirements of non-CTIMP clinical trials from 28 April 2026.

What is changing?

Registering your trial should happen before the first participant is recruited or within 90 days of approval - whichever is earlier.

We require registration in any registry on the World Health Organisation (WHO) list of primary registries or the International Committee of Medical Journal Editors (ICMJE) list of registries that facilitates public access to information about the UK trial. This means that it must be possible for members of the public to identify and access information about trials in the United Kingdom. Not registering is a breach of approval conditions, unless a deferral has been agreed.

Guidance on each area of research registration of non-CTIMP clinical trials can be found on this page. Select a topic from the list below to jump to the relevant section.

• where should you register your clinical trial
• types of clinical trials that are not regulated under the clinical trials regulations
• when to register your clinical trial
• what details you should include when registering your clinical trial
• information about your clinical trial that is shared on the HRA website
• what happens if you abandon the clinical trial
• registration of research tissue banks

Where should you register your clinical trial

You should register your clinical trial on a public registry. This means a primary or partner registry of, or a data provider to, the World Health Organization (WHO) International Clinical Trials Registry Platform that facilitates public access to information about the UK trial.

We ask sponsors to use either ISRCTN or ClinicalTrials.gov as these both feed in to Be Part of Research. This is a free service which makes it easy to find and take part in vital health and care research across the UK. This also helps bring us closer to having a full record of all UK clinical trials in a single place.

Types of clinical trials that are not regulated under the clinical trials regulations

The regulations do not apply to the following clinical trials:

• a clinical investigation or other study of a medical device
• any other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice, for example research involving trials of surgical interventions, radiotherapy, imagine investigations, mental health investigations or therapies, physiological investigations, mental health investigations or therapies, and complementary or alternative therapies

When to register your clinical trial

The sponsor must register the trial within 90 calendar days of the REC favourable approval or before they recruit the first participant - whichever is sooner.

What details you should include when registering your clinical trial

If your trial is already registered when you complete your Integrated Research Approvals System (IRAS) application, you should include your registration number. If you register after submitting your IRAS application, you should email study.registration@hra.nhs.uk with your registration number as soon as possible.

You should make sure you keep the record in the registry up to date.

If you make changes to your study, you must update the publicly accessible record as needed.

Information about your clinical trial that is shared on the HRA website

We publish details of all research in the UK that is reviewed by a REC or is seeking HRA Approval in the research summaries section of our website. This includes information about the planned research, a summary of the research as submitted to the REC, and the REC’s opinion.

We also publish details of all applications approved by the Confidentiality Advisory Group (CAG) in the CAG registry. This contains summary information about the activity, details of the identifiers approved and applicant contact details.

If you choose to defer your study, we will still publish a minimum research summary. At the end of the deferral period, we will publish the full research summary.

This information is pulled through from your research application page on IRAS.

What happens if you abandon the clinical trial

If you decide to abandon a clinical trial before it begins (before any trial procedures such as patient screening or consent set out in the protocol have been initiated), then the trial will not need to be registered.

Registration of research tissue banks

It is a condition of a favourable ethics opinion that all research tissue banks are registered on the UK Clinical Research Collaboration (UKCRC) Tissue Directory.

The research tissue bank should be registered no later than 90 days after favourable opinion, or 90 days after the research tissue bank holds tissue with the intention to provide for research purposes.

Registration means having added details of the types of tissue samples held in the tissue bank. Your research registration reference number should be entered in your dataset on IRAS, so that this can be included on your application form.

See our research tissue bank webpage for further information.

For all other non-CTIMP research

As part of the HRA’s transparency strategy we encourage research sponsors to register their research on a publicly accessible database where possible.

For non-CTIMPs that are not clinical trials, registration on an organisation’s website is sufficient for some studies.

We do not expect studies for educational purposes to be registered (for further information about student research, read our guidance on student research).

We publish details of all research in the UK that is reviewed by a REC or is seeking HRA Approval in the research summaries section of our website. This includes information about the planned research, a summary of the research as submitted to the REC, and the REC’s opinion.

We also publish details of all applications approved by the Confidentiality Advisory Group (CAG) in the CAG registry. This contains summary information about the activity, details of the identifiers approved and applicant contact details.

If you choose to defer your study, we will still publish a minimum research summary.

At the end of the deferral period, we will publish the full research summary. This information is pulled through from your research application page on IRAS.