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Combined review for all CTIMP studies from January 2022

26 July 2021

A combined review service will consider all CTIMP (Clinical Trials of Investigational Medicinal Products) applications that are submitted from 1 January 2022, the Health Research Authority (HRA) has announced.

The service means investigators will submit one application for both Clinical Trial Authorisation and Research Ethics Committee opinion. It is designed to reduce study set up times and offer a single application route.

The same streamlined application and review process will be in place for any subsequent substantial amendments to the trial authorisation.

The combined review service – formerly known as Combined Ways of Working – is open now to all CTIMP sponsors and applicants. Sponsors and investigators are encouraged to familiarise themselves with the new process and where possible, gain experience of using the new service early. To register and get started with the service, researchers are asked to email cwow@hra.nhs.uk.

The HRA has put together information and guidance on the new system. Find out more about the service and read the guidance.