Annual Safety Reporting Requirements

The HPRA requires that an annual safety report, in the format of a Development safety update report (DSUR) is submitted for any trial which is ongoing in Ireland.

For further information, please see the following:

• The HPRA Guide to Clinical Trial Applications
• Section E2F of the ICH website .
• The European Commission ‘Eudralex’ website (Volume 10, Chapter II) 
• The Key Documents list on The Heads of Medicines Agencies Clinical Trials Facilitation Group website
• Clinical Trials Seminar for non commercial sponsors – Responses to Participants Queries