User contributions for Gxplex admin

29 June 2026

• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9 1 revision imported
• 15:2815:28, 29 June 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
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.12 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.29 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - comparator product 1 revision imported
• 15:2815:28, 29 June 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
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Comparator 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational Product 1 revision imported
• 15:2815:28, 29 June 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
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126 (4) - (5) 1 revision imported
• 15:2815:28, 29 June 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
• 15:2815:28, 29 June 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
• 15:2815:28, 29 June 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
• 15:2815:28, 29 June 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
• 15:2815:28, 29 June 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
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E9 Guideline 1998 2.3.1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E9 Guideline 1998 2.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) 5.6 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking 1 revision imported
• 15:2815:28, 29 June 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. Adherence 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) 7 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) 5.1 1 revision imported