User contributions for Gxplex admin

27 June 2026

• 20:4320:43, 27 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 49 1 revision imported
• 20:4320:43, 27 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 - Organisation 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.1 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.6 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.1 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.3 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart E 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (4) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (i) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (e) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-001 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-001 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 disclosure 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Investigator 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (h) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (d) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigator 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-001 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 25 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:N.A. Article from Mora et al. 2023 - 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.2 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.2 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 1.4 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - principal investigator 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sub-Investigator 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C. 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.45 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.40 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (o) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (n) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.52 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.50 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (f) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (1) - (5) 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-002 1 revision imported