User contributions for Gxplex admin

29 June 2026

• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 6 Paragraph 1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV. 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III. 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (8) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (5) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.117 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.116 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.27 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.25 (a) - (b) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.24 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.23 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.22 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.20 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (l) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-002 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (p) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (e) (1) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (g) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 5 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 4 – 6 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 1 – 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 96 Nr. 10, 11, 21 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 6 – 7 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 6-8 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 2-3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4. 1 revision imported