Module 5 Presentations

05/07/2024

Sponsor’s responsibilities (2)

Reporting timelines  Fatal/life-threatening (LT): within 7 days  All other SUSARs: within 15 days  If a SUSAR turns out to be fatal/LT: not later than seven days after the Sponsor became aware of the reaction being fatal or life-threatening.

The Organisation for Professionals in Regulatory Affairs

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Sponsor’s responsibilities from 1 st January 2021 If your trial is being conducted only in the UK

You must report all UK-relevant SUSARs DIRECTLY to MHRA: ● SUSARs originating in the UK for your trial ● SUSARs originating outside the UK for your trial ● If you are the Sponsor of another ongoing trial outside the UK involving the same medicinal product ● SUSARs involving the same medicinal product if the Sponsor of the trial outside the UK is either part of the same mother company or develops the medicinal product jointly, on the basis of a formal agreement, with the UK sponsor

The Organisation for Professionals in Regulatory Affairs

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