User contributions for Gxplex admin

16 July 2026

• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:AUT BASG - FAQ 11-Feb-2025 Änderung am Personal 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 6.3 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (3) 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 42 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 41 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 40 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 8 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-002 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 71 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 75 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 24 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 23 Paragraph 3-6 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 23 Paragraph 1-2 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 22 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 21 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 20 Paragraph 4-7 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 20 Paragraph 1-3 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 19 Paragraph 2-4 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 19 Paragraph 1 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 18 Paragraph 1-3 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 17 Paragraph 4-5 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 17 Paragraph 1-3 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 16 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 15 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 2 Paragraph 13 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 7.5.1 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials 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 4.4 - Amendment 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 3.2 - Responsibility 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 Q15 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 - 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 - 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 - 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 - 1 revision imported current
• 13:5013:50, 16 July 2026 diff hist 0 m Reference:AUT FAQ - COVID-19 Studien 15-Mar-2021 - 1 revision imported current
• 13:5013:50, 16 July 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 current
• 13:5013:50, 16 July 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 current
• 13:5013:50, 16 July 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 current
• 13:5013:50, 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. 1 revision imported current
• 13:5013:50, 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 III B. 3. 1 revision imported current
• 13:5013:50, 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 III - IV. 1 revision imported current