Glossary:TAG-00045-Adv-hte

Glossary > Adverse event

Adverse event
Tag-ID	TAG-00045-Adv-hte
English	Adverse event / Adverse experience / Untoward event
EN Abbr.	AE
French	Événement indésirable / Effet indésirable / Manifestation indésirable
FR Abbr.	EI
German	Unerwünschtes Ereignis / Unerwünschtes Vorkommnis / Nachteiliges Ereignis
DE Abbr.	UE

References

	Scope	Document part	Language	Document
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1	G	Section 7 7.3.1	EN	EU 2011/C 172/01 - CT-3 11-Jun-2011
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59	MD	Article 2 Paragraph 57 – 59	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 1-2	MD	Article 80 Paragraph 1-2	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 2 Paragraph 60 – 62	IVD	Article 2 Paragraph 60 – 62	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 1	IVD	Article 76 Paragraph 1	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 ANNEX III Section 2.1	HM	ANNEX III Section 2.1	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
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001	HM	Article 41	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002	HM	Article 41	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m)	HM	Article 2 (m)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction	HM	Article 2 adverse event adverse reaction	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E19 Guideline 2022 6	G	6	EN	ICH ICH E19 Guideline 2022
ICH ICH E6 Guideline R3 (2025) Appendix B 9.4	G	Appendix B 9.4	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE)	G	GLOSSARY - Adverse Event (AE)	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d)	G	III. Annex 1 2.7.2 (a) - (d)	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1	MD	3.1	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2	MD	3.2	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F	MD	Annex F	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event	HM	§ 312.32 - Adverse event	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event	HM	§ 312.32 - Life-threatening Adverse event	EN	USA 21 CFR Part 312 09-Apr-2025
USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) -	G	-	EN	USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation	G	Introduction ; III. B. ; Evaluation	EN	USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1.	G	2.1.1.	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 5.1	G	5.1	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 5.2	G	5.2	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 5.3.1	G	5.3.1	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 5.3.2	G	5.3.2	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 5.6.6.1	G	5.6.6.1	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 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 7.1 - Committee	HM	7.1 - Committee	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator	HM	7.1 - Investigator	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor	HM	7.1 - Sponsor	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 - Sponsor	HM	7.2 - Sponsor	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event	HM	Glossary - adverse event	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995