The European Medicines Agency have published: Scientific guideline: Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol, draft: consultation open.
This guideline outlines the practical arrangements for notification of serious breaches of clinical trials authorised 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. More information is available on the EMA’s website.
The EMA consultation deadline is the 22nd August, 2017. Comments can be submitted before the 18th August to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.