Clinical trials for medicines: manage your authorisation, report safety issues

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory procedures for managing Clinical Trials of Investigational Medicinal Products (CTIMPs) under the Medicines for Human Use (Clinical Trials) Regulations 2004. Valid until April 28, 2026, the document mandates the use of the combined review service via the Integrated Research Application System (IRAS) for new trial applications. Sponsors must perform specific actions to maintain compliance, including submitting substantial amendments for changes affecting subject safety or trial integrity, which the MHRA assesses within 35 days. Safety reporting is a critical requirement; fatal or life-threatening Suspected Unexpected Serious Adverse Reactions (SUSARs) must be reported within seven days, while others must be submitted within fifteen days. Furthermore, Urgent Safety Measures require immediate telephone notification within three days of implementation. Administrative issues, such as failing to provide proof of payment for Development Safety Update Reports (DSURs) or submitting invalid documentation, can lead to the rejection of applications. The MHRA warns that non-compliance or failure to settle fees may result in penalty charges, the suspension of trial authorizations, and legal action. To conclude a trial, sponsors must file a declaration within 90 days of the global end-date and ensure summary results are published within one year.