Module 5 Presentations

05/07/2024

Urgent safety measures

Substantial amendments of the protocol and/or IB require prior approval of the National Competent Authority and Ethics Committee (EC) But The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety. o The procedures for informing the MHRA and EC in the UK are detailed in SI 2004 No. 1031, 30 (1,2) o For the EU: CTR Article 54

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Safety submissions

In the UK • USM : submit your USM substantial amendment using MHRA Submissions via the Human Medicines Tile or via the Integrated Research Application System (IRAS) if the trial was assessed via Combined Review. For more information: Clinical trials for medicines: manage your authorisation, report safety issues - GOV.UK (www.gov.uk) • DSUR : You must submit your DSUR using MHRA Submissions via the Human Medicines Tile or via the Integrated Research Application System (IRAS) if the trial was assessed via Combined Review. For more information: Clinical trials for medicines: manage your authorisation, report safety issues - GOV.UK (www.gov.uk)

FOR THE EU : Via Clinical Trials Information System (CTIS) Clinical Trials Information System | European Medicines Agency (europa.eu)

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