User contributions for Gxplex admin

29 June 2026

• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (o) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (n) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.52 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.50 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (f) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (1) - (5) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-002 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 24 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7. 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.27 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:INT ISPE - GPP Revision 3 (2015) II. 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) - 1 revision imported
• 15:0715:07, 29 June 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
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) 5. 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:N.A. SPIRIT 2013 - Chan et al. 2013 - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 1 revision imported