Safety reporting in clinical trials
Annual safety reporting requirements
Under the Clinical Trials Directive (CTD)
The sponsor should submit an annual safety report, in the format of a Development Safety Update Report (DSUR), to the HPRA and NREC for any trial which is ongoing in Ireland.
For further information, please see the following:
Under the Clinical Trials Regulation (CTR)
The sponsor should submit an Annual Safety Reports (ASR) to a protected section of CTIS where at least one trial for that active substance is ongoing under the CTR. This submission will cover that active substance in all clinical trials whether authorised under CTR or CTD.
The sponsor should submit an ASR every year from the start of the clinical trial in any Member State until the end of the last clinical trial conducted by the sponsor with the active substance. The ASR documentation will not be published.
Sponsors submitting ASRs should consult:
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).
For trials continuing under the CTD, SUSARs should be submitted to both EVCTM and the NREC, but for trials authorised under the CTR, SUSAR submission to EVCTM only is required.
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.
For further information and safety management in clinical trials, please see: