Glossary:TAG-00032-Inf-ngs

Glossary > Consent process

Consent process
Tag-ID	TAG-00032-Inf-ngs
English	Informed consent process / Consent process / Consent procedure
French	Processus de consentement éclairé / Procédure de consentement / Démarche de consentement
German	Aufklärungsprozess / Einwilligungsprozess / Informed-Consent-Prozess

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
EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.	G	4.	EN	EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017
EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6	G	Page 6	EN	EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022
ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2	G	Annex 2 2.2	EN	ICH ICH E6 Guideline - Annex 2 R3 Annex 2
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Informed Consent	G	GLOSSARY - Informed Consent	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2	MD	5.8.2	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001	G	II. Advertising	EN	USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002	G	II. Advertising	EN	USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction	G	II. Introduction	EN	USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61	G	Page 60-61	EN	WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005