Glossary:TAG-00004-Ser-ege

Glossary > Serious adverse reaction

Serious adverse reaction
Tag-ID	TAG-00004-Ser-ege
English	Serious adverse reaction / Serious side effect
EN Abbr.	SAR
French	Effet indésirable grave / Réaction indésirable grave
FR Abbr.	EIG
German	Schwerwiegende Nebenwirkung / Schwerwiegende unerwünschte Arzneimittelwirkung
DE Abbr.	SNW

References

	Scope	Document part	Language	Document
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o)	HM	Article 2 (o)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event	HM	Article 2 serious adverse event	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE	HM	§ 312.32 - SAE	EN	USA 21 CFR Part 312 09-Apr-2025