The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014). The guideline is intended to provide advice on what is to be classified as a serious breach and sets out the types of incidents that should be reported. The consultation is open until August 22, 2017.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
