Glossary:TAG-00048-Sus-ngV

Glossary > SUSAR

SUSAR
Tag-ID	TAG-00048-Sus-ngV
English	Suspected unexpected serious adverse reaction
EN Abbr.	SUSAR
French	Effet indésirable grave et inattendu suspecté / Réaction indésirable grave et inattendue suspectée
FR Abbr.	EIGIS
German	Mutmaßliche unerwartete schwerwiegende Nebenwirkung / Verdächtige unerwartete schwerwiegende Nebenwirkung
DE Abbr.	SUSAR

References

	Scope	Document part	Language	Document
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3	G	Section 7 7.3.3	EN	EU 2011/C 172/01 - CT-3 11-Jun-2011
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 42	HM	Article 42	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53	G	R1123-53	FR	FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025
GBR Directive 2001/20/EC 04-Apr-2001 Article 17	HM	Article 17	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 33	HM	Article 33	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 34	HM	Article 34	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)	G	GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)	EN	ICH ICH E6 Guideline R3 (2025)
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34	G	2.1.32 - 2.1.34	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024