Formerly known as the Combined Ways of Working (CWoW), the new Combined Review Service, will be utilised to submit new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications from January 01, 2022. It encompasses a “single submission, a coordinated review, and combined communications” process to facilitate all communications between the authority and all the CTIMP sponsors and applicants.
The system will allow the sponsor or applicant to submit a single application to both the MHRA and Research Ethics Committee (REC). The consequent MHRA authorization and REC opinion would thereby be delivered together in one step. This streamlined process will also apply to further requests sponsors or applicants make for any substantial amendments to the trial authorisation. The system will also allow viewing and revision of the application information directly in the system.
The facilitate the transition, NHS has released a step by step guide to using IRAS for combined review – Health Research Authority (hra.nhs.uk).