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

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

References

	Scope	Document part	Language	Preview
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1	G	3.1	EN	3. How to report a serious breach 3.1. Who should notify The sponsor is responsible for the notification via the EU portal and EU database - part of …
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	G	3.2	EN	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 bre…
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4	G	4	EN	4. Clarification on reporting requirements • Serious breaches which occurred outside the EU/EEA while the application for a clinical trial authorisati…
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1	G	5.1	EN	5.1. What needs to be reported? Any breach of: • The Regulation (EU) No 536/2014. or • The clinical trial protocol version applicable at the time of …
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	G	6.4	EN	6.4. Principal Investigator The principal investigator should have a process in place to ensure that: • the site staff or service providers delegated…
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I	G	Appendix I	EN	Appendix I – Examples of serious breaches…