7. General considerations for serious breaches: Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

Due to the special nature of fraud it is expected that all concerns about potential cases of fraud in clinical trials which the sponsor becomes aware of are reported as serious breaches. National legislation must also be taken into consideration with reference to criminal acts.

The party (e.g. sponsor, CRO, investigator) at which the serious breach occurred should verify the impact of the breach on other clinical trials (ongoing or ended) where they are involved/ which they manage.

In some instances, a breach of the Regulation (EU) No 536/2014 or of the protocol (e.g. a mis-dosing in relation to an error) which may result in a Serious Adverse Event (SAE) or a Suspected Unexpected Serious Adverse Reaction (SUSAR) can constitute a serious breach. If failure to manage safety events, for example lack of SUSARs reporting, results in trial participants being put at a significant degree of risk, then this will constitute a serious breach which needs to be reported. This doesn’t exempt the sponsor from the obligation to report, if relevant, other safety related notifications, as per the requirements of the Regulation (EU) 536/2014 (in accordance with Articles 53 and 54), in addition to the submission of those SUSARs to the EudraVigilance database.

If persistent or systematic non-compliance with the Regulation (EU) 536/2014 (including deviation from the principles of the GCP or the protocol as described in Article 47 of the same Regulation) is likely to significantly affect the safety and rights of a trial participant in the EU/EEA or on the reliability and robustness of the data of the trial, this will constitute a serious breach.

If a serious breach occurred at one investigator site within or outside of the EU/EEA for a clinical trial authorised/conducted also in the EU/EEA and this leads to the removal of data from the trial analysis, then this should be notified as well. Appendix I contains examples of situations that may be considered as serious breaches depending on the context of the situation.

© European Medicines Agency, 2021

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