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

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA), effective April 28, 2026, details the required procedures for collecting and reporting safety events within clinical trials. Operating under the Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 amendments, the framework incorporates international standards from the ICH. Investigators are required to report all Serious Adverse Events (SAEs) to sponsors within a 24-hour window. Sponsors must then evaluate these events against the Reference Safety Information (RSI) to identify Suspected Unexpected Serious Adverse Reactions (SUSARs) for expedited regulatory reporting. The guidance emphasizes strict adherence to Medical Dictionary for Regulatory Activities (MedDRA) coding to maintain data consistency across trials. A primary focus is the management of the RSI, which must be clearly defined within the Investigator’s Brochure or Summary of Product Characteristics. Sponsors are expected to conduct annual reviews of safety data and update the RSI accordingly, often in parallel with the Development Safety Update Report (DSUR). Any significant changes to the RSI must be submitted as a "substantial modification" for regulatory approval before being implemented. Additionally, the guidance specifies that trials led by non-physician investigators must include a qualified doctor or dentist to provide medical oversight and final causality assessments. Failure to comply with these standardized reporting timelines and documentation requirements may jeopardize trial compliance and participant safety.