Research transparency requirements for non-CTIMP clinical trials

The changes bring the registration and deferral rules for trials outside the amended UK clinical trials regulations in line with the new legal 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.

The changes will apply from 28 April 2026.

Clinical trials that are not CTIMPs

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.

Although non-CTIMPs do not fall under the clinical trials regulations, it remains a condition of a Research Ethics Committee (REC) favourable opinion that a clinical trial is registered. It is expected that research sponsors make information about their trials publicly available, and offer to share the results with participants.

Plain language summary of findings should also be submitted as part of the Final Report. These are published alongside the research summary record on the research summaries section of the HRA website.

What is changing for non-CTIMP clinical trials?

Registration requirements

The 6 week period in which to register a trial following recruitment of the first participant has been removed. From 28 April 2026 non-CTIMP clinical trials will need to register before the first participant is recruited or within 90 days of approval - whichever is earlier.

Deferral timelines

Deferrals from the requirement to register will be given for a period of 30 months from the end of trial date. If the sponsor changes the end of trial date, the deferral will remain consistent with the updated end of trial date.

The following pages provide more information on the research transparency requirements and best practice expectations for non-CTIMPs:

• registering research transparency requirements for non-CTIMPs
• deferring research transparency requirements for non-CTIMPs