User contributions for Gxplex admin

16 July 2026

• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.50 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.8 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.300 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 45 CFR Part 160 09-Apr-2025 - 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling 1 revision imported current