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• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-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 § 812.150 (b) (1) - (3) 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) (2) 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)-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 § 812.3 (q) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.45 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 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.42 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.38 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.123 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.113 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.113-002 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.-002 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (11) 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 (c) 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 Schedule 5 (5) 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 27 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 Schedule 3 Part 1 1. (p) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002 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 Paragraph 5 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 Paragraph 1 – 3 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 Paragraph 3 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 38 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 37 Paragraph 1 – 7 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 2 Paragraph 26 - 29 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 8.2 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WMA Declaration of Helsinki 2024 34 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 5.14 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 4.15 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E9 Guideline 1998 4.5 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 3.17.1 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 2.6 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2 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 3 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 Schedule 1 Part 2 16. by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 26 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40a Absatz 3 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 65 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 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)