We're making some changes to the deferrals timelines for non-CTIMP clinical trial studies.
The changes bring the deferrals 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 and associated deferrals 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.
What is changing?
From 28 April 2026, deferrals from the requirement to register will be given, where justified, 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.
This replaces the current policy where deferrals are agreed for 12 month periods up to a maximum of 30 months after the end of the trial.
The sponsor will be able to request further 30 month deferrals up to a maximum of 10 years from the end of the trial.
However, we will not normally agree a further deferral for registration beyond 30 months after the end of the study unless the sponsor can provide strong justification for doing so.
Trials with a deferral in place before 28 April 2026
If a clinical trial is approved, has a deferral in place and the trial is still ongoing by 28 April 2026, the deferral's end date will be extended to 30 months after the end of the trial.
The sponsor does not need to do anything to have this extension applied - it will be updated automatically.
If the sponsor chooses not to use this extension for the deferral period they can do so. It will be the sponsor's choice as to whether the extended deferral period is used.
If a clinical trial is approved and has a deferral in place by 28 April 2026, but the end of the trial has already been declared, the deferral will not be automatically extended. However, the sponsor will be able to request an extension if required.
Clinical trials regulations guidance
For more information about the changes to CTIMPs, read our clinical trials regulations guidance.