User contributions for Gxplex admin

16 July 2026

• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 64 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 2-3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 2-3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g) 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E7 Guideline 1993 - 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E11 Guideline R1 (2017) 8 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E11 Guideline R1 (2017) - 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E21 Concept paper 2023 2. 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) II 2.4 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.8 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.13 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1.2.7 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.9 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Vulnerable Participants 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.512 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.508 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR Data Protection Act 2018 06-Jun-2022 Schedule 10 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR Data Protection Act 2018 06-Jun-2022 Article 2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 6 Paragraph 1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 9 Paragraph 2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 9 Paragraph 1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:GBR Medicines and Medical Devices Act 2021 21-Feb-2021 Chapter 2 Article 8 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 4 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 6 Paragraph 1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 2 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.1 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV. 1 revision imported current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III. 1 revision imported current
• 13:4913:49, 16 July 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 current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction 1 revision imported current
• 13:4913:49, 16 July 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 current
• 13:4913:49, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (8) 1 revision imported current