Glossary:TAG-00025-Sub-mer

Glossary > Trial participant

Trial participant
Tag-ID	TAG-00025-Sub-mer
English	Subject / Trial participant / Patient
French	Participant / Participante / Sujet / Patient / Patiente
German	Prüfungsteilnehmer / Prüfungsteilnehmerin / Proband / Probandin / Patient / Patientin

References

	Scope	Document part	Language	Document
CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23	G	Page 23	EN	CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016
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
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 26	MD	§ 26	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 (f)	HM	Article 28 Paragraph 1 (f)	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 2001/20/EC 04-Apr-2001 Article 3	HM	Article 3	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 28	HM	Article 28	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 Schedule 1 Part 3-001	HM	Schedule 1 Part 3	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 Schedule 1 Part 3-002	HM	Schedule 1 Part 3	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3	HM	Annex 2 3	EN	ICH ICH E6 Guideline - Annex 2 R3 Annex 2
ICH ICH E6 Guideline R3 (2025) Appendix B 6-001	G	Appendix B 6	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix B 6-002	G	Appendix B 6	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8	G	III. Annex 1 2.8	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.1	G	III. Annex 1 2.9.1	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E8 Guideline R1 (2021) 6.2.2	HM	6.2.2	EN	ICH ICH E8 Guideline R1 (2021)
ICH ICH E9 Guideline 1998 Glossary - Dropout	HM	Glossary - Dropout	EN	ICH ICH E9 Guideline 1998
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (g)	G	§ 50.3 (g)	EN	USA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (p)	MD	§ 812.3 (p)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.102 (e) (1)	G	§ 46.102 (e) (1)	EN	USA 45 CFR Part 46 09-Apr-2025
WHO WHO - Guidance for best practices for clinical trials 2024 2.1.8	G	2.1.8	EN	WHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidance for best practices for clinical trials 2024 Annex 2 2.5	G	Annex 2 2.5	EN	WHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1	HM	4.1	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44	G	Page 44	EN	WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
WMA Declaration of Helsinki 2024 Paragraph 25 – 28	G	Paragraph 25 – 28	EN	WMA Declaration of Helsinki 2024
WMA Declaration of Helsinki 2024 Paragraph 31 – 32	G	Paragraph 31 – 32	EN	WMA Declaration of Helsinki 2024
WMA Declaration of Helsinki 2024 Paragraph 9	G	Paragraph 9	EN	WMA Declaration of Helsinki 2024