Guidance on submitting clinical trial safety reports
Guidance on submitting clinical trial safety reports How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs). From: Print this page 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. 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 relevant member states, as well as ...
Source: gov.uk