March 2022: Phase 1 Review Timelines and Seven-day Submission

On 04 March 2022, HRA UK posted an update regarding the review timelines for Phase 1 studies. Many Research Ethics Committees (RECs) will accept the submission of Phase 1 applications up to 7 days before the REC meeting date. To make a request for seven-day submission for an application, sponsors should contact their preferred REC which is flagged to review Phase 1 clinical trials.

As per the Phase 1 application process, the coordinated initial outcome from the MHRA and REC will be issued together within 7 days of the REC meeting. The aim is to deliver ethics opinions for Phase 1 clinical trials within a short timeframe, while maintaining robust ethics review.

More information related to Phase 1 application process can be found here.