EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

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.

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