UK – Guidance on submitting clinical trial safety reports from 1 January 2021

How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).

From 1st January 2021, you must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways:

If you intend to submit SUSARs using one of the new reporting routes, you must register as soon as possible before 1 January 2021.

For trials ongoing in both the UK and in European member states dual reporting is needed. You will need to report each SUSAR to both the MHRA and to the European Medicines Agency’s (EMA’s) Eudravigilance Clinical Trial Module (EVCTM)…