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• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 6-8 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 2-3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4. by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidance for best practices for clinical trials 2024 Annex 2 2.5 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) ; e) - g) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WMA Declaration of Helsinki 2024 Paragraph 31 – 32 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Informed Consent by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B. by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.100 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-002 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.25 (e) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 7 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5 (j) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 (j) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 (f) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - escape treatment by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-001 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WMA Declaration of Helsinki 2024 Paragraph 9 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (5) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 Templates by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l) by file upload (1 revision)
• 13:49, 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 Article R1121-3-1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9 by file upload (1 revision)