Glossary:TAG-00154-Vul-eil

Glossary > Vulnerable participants

Vulnerable participants
Tag-ID	TAG-00154-Vul-eil
English	Vulnerable participants / Vulnerable subjects / Vulnerable population
French	Participants vulnérables / Participantes vulnérables / Sujets vulnérables / Population vulnérable
German	Vulnerable Prüfungsteilnehmer / Vulnerable Prüfungsteilnehmerinnen / Schutzbedürftige Prüfungsteilnehmer / Schutzbedürftige Prüfungsteilnehmerinnen / Vulnerable Probanden / Vulnerable Probandinnen

References

	Scope	Document part	Language	Document
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18	G	GUIDELINE 18	EN	CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19	G	GUIDELINE 19	EN	CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 10	G	Article 10	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34	HM	Article 34	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
ICH ICH E21 Concept paper 2023 2.	G	2.	EN	ICH ICH E21 Concept paper 2023
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Vulnerable Participants	G	GLOSSARY - Vulnerable Participants	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E7 Guideline 1993 -	G	-	EN	ICH ICH E7 Guideline 1993
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55	MD	3.55	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 5.7	MD	5.7	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 45 CFR Part 46 09-Apr-2025 Subpart C	G	Subpart C	EN	USA 45 CFR Part 46 09-Apr-2025
WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3	G	2.1.3	EN	WHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g)	HM	3.3 e) - g)	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22	G	Page 22	EN	WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005