User contributions for Gxplex admin

16 July 2026

• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E9 Guideline 1998 2.3.1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E9 Guideline 1998 2.3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) 5.6 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking 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. Adherence 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d) 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 3 Part 1 1. (i) 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 A.6.3-001 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 A A.5 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) 7 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) 5.1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 - 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 3 Part 1 1. ; 3. 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2 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 Q5.2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9 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 K No. 59-60 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 3.42 - recruitment 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 44 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 4.3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V. 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart D 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart C 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart B 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D 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 (s) 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 (r) 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 (q) 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 (p) 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 (o) 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 (n) 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 (m) 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 5 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 4 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 3-002 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41 1 revision imported current