On January 28, 2022, UK HRA posted an update regarding the changes to the deferrals process and automatic registration of a research summary on the HRA website.
From January 31, 2022, the rules around deferring registration and publication of a research summary on the HRA website will change. Below are the changes that will be applicable from January 31, 2022 onwards:
- Publishing limited information: As opposed to the previous process where a deferral from registration of all information was provided, the sponsors will now need to publish a minimum record of the clinical study on a publicly accessible registry if a deferral is agreed by the authority.
- A new maximum timeline: A maximum deferral period of 30 months will be applicable for all deferral requests approved from January 31, 2022, onwards. The initial deferral will still last for 12 months. Sponsors can apply to extend the deferral period by 12 months at a time until the study comes to an end. An extension for another 12 months and then up to a further 18 months can be applied for, by the sponsor (a maximum of 30 months in total from the end of the study).
- How to request a deferral: Trials using combined review can submit a deferral request in the new part of the Integrated Research Application System (IRAS) by answering the deferral question in part C of the study information question set. For all other studies, deferral can be requested by emailing [email protected] Further information on requesting a deferral can be found here.
Update on automatic registration: HRA had started with automatic registration for all new clinical trials of medicines that gained approval through the combined review process since January 01, 2022. Trials submitted through combined review after January 01 that are given approval, are being registered in the ISRCTN Registry.
Automatic registration applies to clinical trials of investigational medicinal products (CTIMPs) and combined trials of an investigational medicinal product and an investigational medical device (IMP/device trials). These trials will be automatically registered once all approvals are in place (HRA/Research Ethics Committee and MHRA approvals) at no cost to the applicant by the authorities. More information related to automatic registration can be found here.