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• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 69 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 76 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.2 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.113-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 (b) - (c) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.56 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 (d) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 31 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 66 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 77 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E9 Guideline 1998 Glossary - Dropout by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported 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 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5) by file upload (1 revision)