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MHRA releases guidance in collaboration with Health Canada to improve patient safety in clinical trials through improving the quality of Development Safety Update Reports

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).
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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 to the European Medicines Agency’s (EMA’s) Eudravigilance Clinical Trial Module (EVCTM). ....

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