UK Guidance on Clinical Trials: How to Apply for Authorization

UK MHRA updated its guidance on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make changes to your application.

As of 1 January 2022 the combined review service, (formerly known as Combined Ways of Working (CWoW), is the way that all new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications are prepared, submitted, and reviewed.

Combined review offers a single application route and coordinated review leading to a single UK decision for CTIMPs.

CTIMP applications via combined review should be started and submitted using the new part of the Integrated Research Application System (IRAS) and not in the standard part of IRAS. While the regulatory requirements and fees remain the same, the application submission, processing, and assessment steps outlined below refer to non-combined review applications.

Click this guideline LINK to know details on

· When a clinical trial authorisation (CTA) is needed

· Trial Sponsor and legal Representative

· Registration of your clinical trial

· Combined review of clinical trials of investigational medicinal products

· Documents to send with your application

· Assessment of your submission

· Common issues identified during clinical trial applications

· Withdraw your request before the final decision

· Risk Proportionate Approaches

· Applications that need expert advice

· Fees

· Contact