Reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) in Clinical Trials

Suspected unexpected serious adverse reactions (SUSARs) occurring during clinical trials undertaken in Ireland should be notified electronically by sponsors via the clinical trials module of the EudraVigilance database (EVCTM).

Non-commercial sponsors can request help from the HPRA when submitting a report to EVCTM. To request this, please email medsafety@hpra.ie when submitting a clinical trial application to facilitate timely completion of arrangements.

Non-commercial sponsors can report directly to the HPRA by submitting an online report. However, if you are experiencing issues with the online form, you can email or post a completed copy of the reporting document to the HPRA.

You can find out more about reporting suspected unexpected serious adverse reactions by visiting the EMA website.