Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

Glossary:TAG-00045-Adv-hte

From GxPlex

Revision as of 17:29, 15 July 2026 by imported>GxPlexBot (Import from GxPlex Excel)
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to: navigation, search


Glossary > Adverse event

Adverse event
Tag-ID TAG-00045-Adv-hte
English Adverse event / Adverse experience / Untoward event
EN Abbr. AE
French ÉvĂ©nement indĂ©sirable / Effet indĂ©sirable / Manifestation indĂ©sirable
FR Abbr. EI
German UnerwĂŒnschtes Ereignis / UnerwĂŒnschtes Vorkommnis / Nachteiliges Ereignis
DE Abbr. UE

References

 ScopeDocument partLanguageDocument
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1GSection 7 7.3.1ENEU 2011/C 172/01 - CT-3 11-Jun-2011
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59MDArticle 2 Paragraph 57 – 59ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2MDArticle 80 Paragraph 1-2ENEU 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 – 62IVDArticle 2 Paragraph 60 – 62ENEU 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 1IVDArticle 76 Paragraph 1ENEU 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. 19HMANNEX I

Section D

No. 19		ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1HMANNEX III Section 2.1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34HMArticle 2

Paragraph 2

No. 32-34		ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001HMArticle 41ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002HMArticle 41ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m)HMArticle 2 (m)ENGBR 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 reactionHMArticle 2

adverse event

adverse reaction		ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E19 Guideline 2022 6G6ENICH ICH E19 Guideline 2022
ICH ICH E6 Guideline R3 (2025) Appendix B 9.4GAppendix B 9.4ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE)GGLOSSARY - Adverse Event (AE)ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d)GIII. Annex 1

2.7.2

(a) - (d)		ENICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1MD3.1ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2MD3.2ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex FMDAnnex FENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse eventHM§ 312.32 - Adverse eventENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse eventHM§ 312.32 - Life-threatening Adverse eventENUSA 21 CFR Part 312 09-Apr-2025
USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) -G-ENUSA 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. ; EvaluationGIntroduction ; III. B. ; EvaluationENUSA 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.G2.1.1.ENUSA 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 5.1G5.1ENUSA 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 5.2G5.2ENUSA 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 5.3.1G5.3.1ENUSA 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 5.3.2G5.3.2ENUSA 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 5.6.6.1G5.6.6.1ENUSA 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 5.13HM5.13ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - CommitteeHM7.1 - CommitteeENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - InvestigatorHM7.1 - InvestigatorENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - SponsorHM7.1 - SponsorENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - SponsorHM7.2 - SponsorENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse eventHMGlossary - adverse eventENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
Retrieved from "https://gxplex.org/index.php?title=Glossary:TAG-00045-Adv-hte&oldid=15580"