Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

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Document details

Download document Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
Reference number EMA/430909/2016
Status draft: consultation open
First published 2017-05-23
Last updated 2017-05-23
Consultation start date 2017-05-23
Consultation end date 2017-08-22
Email address for submissions gcp@ema.europa.eu

Summary

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.