User contributions for Gxplex admin

16 July 2026

• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1. 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) 5. 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:N.A. SPIRIT 2013 - Chan et al. 2013 - 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 Annex A - CIP 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 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 Appendix 2 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 2 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 - protocol 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) II 7.4 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 Paragraph 22 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-001 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001 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 Annex E-001 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.64 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.24 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.8 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.6 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.4 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart D 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.42 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart B 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.124 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.111 - §56.112 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.109 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.105 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.104 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.103 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.102 (m) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 IRAS 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 - 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4. 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (1) - (3) 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 19 - 20 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 18 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 17 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 16 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 15 (7) - (10) 1 revision imported current