User contributions for Gxplex admin

16 July 2026

• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j) 1 revision imported current
• 13:5013:50, 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 12. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 69 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.12 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.29 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - comparator product 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Comparator 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational Product 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126 (4) - (5) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22 1 revision imported current