User contributions for Gxplex admin

16 July 2026

• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (i) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 5-6 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committee 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41c 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41b 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41a 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 Paragraph 23 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-001 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 § 65 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 77 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 - 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Guide de légistique 07-Feb-2024 - 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 38 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 37 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 34 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 24 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 55 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 89 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 N/A 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 15 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 - 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 - 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 - 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 28 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble Preamble 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble Preamble 1 revision imported current