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• 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 34 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 33 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 5. 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.-001 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 3. by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:AUT MPG – Medizinproduktegesetz 26-May-2022 § 22 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002 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 82 Paragraph 3 – 5 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 76 Paragraph 5 – 6 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 76 Paragraph 4 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 76 Paragraph 2 – 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 73 Paragraph 1, 3, 4 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 76 Paragraph 1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001 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 87 Paragraph 3 – 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 87 Paragraph 1 – 2 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 80 Paragraph 5 – 6 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 80 Paragraph 4 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 80 Paragraph 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 80 Paragraph 1-2 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 & 4 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 53 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 43 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 42 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 41-002 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 3.13.2 (c) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E2F Guideline 2010 1 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 9.2.5 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78 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 13 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 7.1 - Committee by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E9 Guideline 1998 Glossary - IDMC by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8 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 3.9 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Independent Data Monitoring Committee (IDMC) 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 7.2 - Sponsor 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 7.1 - Sponsor 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 5.13 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 3.13.2 (a) - (b) ; (d) - (f) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E2A Guideline 1994 III E by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E2A Guideline 1994 III B. - III C. 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 5.3.2 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 5.3.1 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 Appendix 1 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 4.3 by file upload (1 revision)