Glossary > 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 |
