Glossary:TAG-00046-Ser-sSc

Glossary > Serious adverse event

Serious adverse event
Tag-ID	TAG-00046-Ser-sSc
English	Serious adverse event / Serious adverse experience
EN Abbr.	SAE
French	Événement indésirable grave / Effet indésirable grave
FR Abbr.	EIG
German	Schwerwiegendes unerwünschtes Ereignis / Schwerwiegendes unerwünschtes Vorkommnis
DE Abbr.	SUE

References

	Scope	Document part	Language	Document
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63	MD	§ 63	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64	MD	§ 64	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3	MD	Article 80 Paragraph 3	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4	MD	Article 80 Paragraph 4	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 2 – 3	IVD	Article 76 Paragraph 2 – 3	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4	IVD	Article 76 Paragraph 4	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19	HM	ANNEX I Section D No. 19	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34	HM	Article 2 Paragraph 2 No. 32-34	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001	MD	2.	FR	FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002	MD	2.	FR	FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025
GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001	MD	2.	EN	GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021
GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002	MD	2.	EN	GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021
GBR Directive 2001/20/EC 04-Apr-2001 Article 16	HM	Article 16	EN	GBR Directive 2001/20/EC 04-Apr-2001
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 Directive 93/42/EEC 11-Oct-2007 Annex X	MD	Annex X	EN	GBR Directive 93/42/EEC 11-Oct-2007
GBR MEDDEV 2.7/3 revision 3 May-2015 4	MD	4	EN	GBR MEDDEV 2.7/3 revision 3 May-2015
GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6	MD	5 - 6	EN	GBR MEDDEV 2.7/3 revision 3 May-2015
GBR MEDDEV 2.7/3 revision 3 May-2015 7.1	MD	7.1	EN	GBR MEDDEV 2.7/3 revision 3 May-2015
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
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 32	HM	Article 32	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction	G	II B. Serious Adverse Event or Adverse Drug Reaction	EN	ICH ICH E2A Guideline 1994
ICH ICH E2A Guideline 1994 II B. Serious/Severe	G	II B. Serious/Severe	EN	ICH ICH E2A Guideline 1994
ICH ICH E2A Guideline 1994 III A. 2.	G	III A. 2.	EN	ICH ICH E2A Guideline 1994
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE)	G	GLOSSARY - Serious Adverse Event (SAE)	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45	MD	3.45	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE	HM	§ 312.32 - SAE	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b)	HM	§ 312.64 (b)	EN	USA 21 CFR Part 312 09-Apr-2025
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21.	G	2.1.21.	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28	G	2.1.28	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10	HM	4.10	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13	HM	5.13	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator	HM	7.2 - Investigator	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event	HM	Glossary - serious adverse event	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995