Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4

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	6.4
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Serious breach, Principal investigator, Site staff, Investigator responsibilities

Content

6.4. Principal Investigator The principal investigator should have a process in place to ensure that: • the site staff or service providers delegated by the principal investigator/institution are able to identify the occurrence of a (suspected) serious breach; • a (suspected) serious breach is promptly reported to the sponsor or delegated party, through the contacts (e-mail address or telephone number) provided by the sponsor or delegated party;

This may be a formal standard operating procedure or a study-specific guidance.