Today (04 July 2023) the European Medicines Agency released a scientific guideline "Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol" that provides advice on what should and what should not be classified as a serious breach and what must be reported.
A Serious Breach is defined as any deviation of the approved protocol version or the clinical trial regulation that is likely to affect the safety, rights of trial participants, and/or data reliability and robustness to a significant degree in a clinical trial.
Any of the following breaches are considered to be serious and should be notified:
The Regulation (EU) No 536/2014. or
The clinical trial protocol version applicable at the time of the breach. which is likely to affect to a significant degree:
The safety of a trial participant and/or
The rights of a trial participant. and/or
The reliability and robustness of the data generated in the clinical trial
The sponsor is responsible for the notification via the EU portal and EU database - part of the Clinical Trials Information System (CTIS). The notification should be made without undue delay and at the latest within 7 calendar days of the sponsor becoming aware of a serious breach.
From the moment they receive information about a (suspected) serious breach, the sponsor should evaluate it in a timely manner.
As part of a written contract, the sponsor should require all parties involved with the clinical trial, according to their responsibilities, to immediately report events that might meet the criteria for a serious breach to the sponsor's designated contact point, regardless of the nature of the event.
Click this LINK to know more about the General considerations for serious breaches and the Responsibilities of parties involved in the notification of a serious breach.