Combined review
Combined review offers a single application, leading to a single UK decision, and a faster overall timeline.
From 1 January, this is the only way to apply for new clinical trials of investigational medicinal products (CTIMPs) or combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials).
Combined review is from the Medicine and Healthcare products Regulatory Agency (MHRA) and the HRA, and you can read more on our website.
We’re holding a series of free, live webinars to help you prepare for combined review. Find out more and book a place for one of our January sessions.
Automatic registration
We’ve partnered with ISRCTN Registry to make sure information about all clinical trials is made public.
All studies submitted through combined review on or after after 1 January will be automatically registered when given approval, saving you time.
Changes to deferral and publication of research summary
As part of our commitment to research transparency, we’re changing our policy for deferring the registration of a clinical trial and the publication of trial information on the research summaries database.
Changes come into effect on 31 January 2022 and include:
- a maximum deferral period of 30 months from the end of the trial
- guidance for a minimum amount of information to be published on an approved registry
Further guidance will be published in the new year. If you have comments or questions about the new deferral policy, please send them to research.transparency@hra.nhs.uk by 21 January.
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