Serious breach reporting in clinical trials

Clinical trials authorised under the Clinical Trials Directive (CTD)

Under the CTD, there is no obligation on a sponsor to report serious breaches to the HPRA. However, the HPRA will accept any reports of serious breaches that are communicated on a voluntary basis. Sponsors are also reminded of their existing obligations for regulatory reporting under S.I 190 of 2004, as amended, which would include any urgent safety measures or suspensions to a trial. Further information is available in the HPRA Guide to Clinical Trial Applications under the CTD.

Clinical trials authorised under the Clinical Trials Regulation (CTR)

A sponsor is required to report serious breaches for trials authorised under the CTR through CTIS (Clinical Trials Information System). A serious breach is defined in the CTR (Article 52) as a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.

For further information, please see the EMA Guideline for the notification of serious breaches of the CTR or the clinical trial protocol.