Regulation No 536/2014 states in Article 52 that “the sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version of the protocol applicable at the time of the breach through the EU portal without undue delay but not later than seven days of becoming aware of that breach.”
Currently, the practical arrangements for notification of serious breaches are not outlined and do not include any guidance related to urgent safety measures/reporting obligations related to subject safety. Further, there is currently limited advice available on what should and should not be classified as a serious breach and the details that should be reported. Finally, actions that must be taken by the EU/EEA Member States concerned in response to a serious breach is not clearly defined.
This week the EMA opened for public consultation a draft guideline on serious breaches of clinical trial regulations or clinical trial protocols, the aim of which is to outline the practical arrangements required to address the aforementioned gaps in the guidance.
The public consultation is now open and will remain open until 22 August 2017. Comments should be sent to firstname.lastname@example.org.
Click here to view the draft guideline.