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- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 34 +
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 37 +
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 38 +
- Reference:FRA Guide de légistique 07-Feb-2024 - +
- Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 - +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 77 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85 +
- Reference:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 § 65 +
- Reference:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1 +
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-001 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC) +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26 +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 23 +
- Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41a +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41b +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41c +
- Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4 +
- Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committee +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 5-6 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10 +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (i) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t) +
