Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2

Document information
Reference	EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021
Validity area	EU
Scope(s)	G
Document name	EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
Version / Revision	2021
Status	Current
Document type	Official guideline
Language(s)	EN
Description	EMA/698382/2021 Quality and Safety of Medicines Department Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 4 — Unit 4.1.4
Scope	G
Document part	3.2
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Serious breach, Reporting timeline, Sponsor

Content

3.2. When should the notification be made? Without undue delay and at the latest within 7 calendar days of the sponsor becoming aware of a serious breach.

If the sponsor has reasonable grounds based on evidence to believe that a serious breach has occurred, it is expected to report the serious breach first, within 7 days, and investigate and take action simultaneously or after the notification. In this case, the sponsor should not wait to obtain all of the details related to the breach prior to the notification.

In other cases, some degree of investigation and assessment may be required by the sponsor prior to the notification, in order to confirm that a serious breach has actually occurred. [...]