EMA issues Draft Guideline on Serious Breaches

Breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

This guideline outlines the practical arrangements for notification of serious breaches of clinical trials authorized in the Europe Union / European Economic Area. It aims to provide advice on what should and what should not be classified as a serious breach and what must be reported. It does not include guidance related to urgent safety measures or other reporting obligations related to subject safety.

Consultation end date is the 22nd August 2017.

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