User contributions for Gxplex admin

29 June 2026

• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d) 1 revision imported
• 14:5214:52, 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. 1 revision imported
• 14:5214:52, 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 III B. 3. 1 revision imported
• 14:5214:52, 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 III - IV. 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2 1 revision imported
• 14:5214:52, 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 VI D. 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6.2 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (j) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.5 - 6.7 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.3 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 1 revision imported
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001 1 revision imported
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor 1 revision imported
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.50 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.8 1 revision imported
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6 1 revision imported
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.300 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50 1 revision imported
• 14:5214:52, 29 June 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
• 14:5214:52, 29 June 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
• 14:5214:52, 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 4.8 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 1 revision imported