Clinical Trials for Medicines: Manage your Authorization, Report Safety Issues

On 7 February 2022 the MHRA updated the guidance on managing the clinical trial authorization, reporting safety issues and completing the end-of-trial study report.

As of 1 January 2022 the combined review service, formerly known as Combined Ways of Working (CWoW), is now 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.

Please note: CTIMP initial applications via combined review should be started and submitted using the new part of 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. For Combined review applications please refer to the Health Research Authority website.

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