User contributions for Gxplex admin

29 June 2026

• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.11 – 2.12.14 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Certified Copy 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Metadata 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Source Records 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Integrity 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA FDA Information - Observations and citations 20-Mar-2024 - 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 29A 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 - 1 revision imported
• 15:0815:08, 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 - ComCompliance 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.119 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.70 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 12.3 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) 1 revision imported
• 15:0815:08, 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 6. 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r) 1 revision imported
• 15:0815:08, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m) 1 revision imported