User contributions for Gxplex admin

29 June 2026

• 14:5114:51, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V. 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart D 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart C 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart B 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (s) 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (r) 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (q) 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (p) 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (o) 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (n) 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (m) 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 5 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 4 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-002 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-001 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 4 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 3 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 2 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 1 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 64 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 2-3 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 2-3 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 1 1 revision imported
• 14:5114:51, 29 June 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
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g) 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ICH ICH E7 Guideline 1993 - 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ICH ICH E11 Guideline R1 (2017) 8 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ICH ICH E11 Guideline R1 (2017) - 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ICH ICH E21 Concept paper 2023 2. 1 revision imported
• 14:5114:51, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) II 2.4 1 revision imported