User contributions for Gxplex admin

29 June 2026

• 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 4.8 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 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 Part 1 Article 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 160 09-Apr-2025 - 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) 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 A4.13 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 4.6 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 4.5 CCEAT 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 4.5 ALCOA 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 4.4 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 4.2 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 - Electronic data handling 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 - validation 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10 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 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2. 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:AUT BASG - FAQ 11-Feb-2025 Schwarz 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 - SD 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report - 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.5 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.8 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 GLOSSARY OF TERMS 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (b) 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 1 Part 2 10. 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002 1 revision imported