Reporting Serious Adverse Events 

Serious Adverse Events associated with investigator-led trials can be reported to the HPRA using our online report form.

Further information on safety reporting is available from the detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (European Commission website). In addition, this guidance sets out the responsibilities of the concerned parties.

Guide to Electronic Transmission of ICSRs and SUSARs associated with the use of Human Medicines

Downloadable Form for reporting Serious Adverse Events for Investigator Led Trials