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Detailed GuideMHRA

Clinical trials for medicines: collection, verification and reporting of safety events

Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.

First published: Jun 24, 2025Last updated: Apr 27, 2026Changes: 5

Latest change: Minor wording changes to RSI example table. The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.

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