User contributions for Gxplex admin

16 July 2026

• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E9 Guideline 1998 Glossary - Dropout 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 17 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 35 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 34 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 33 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 5. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:AUT MPG – Medizinproduktegesetz 26-May-2022 § 22 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 5 – 6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 2 – 3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 1, 3, 4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 1 – 2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 5 – 6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1, 3 & 4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 42 1 revision imported current