User contributions for Gxplex admin

27 June 2026

• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU EMA Guidelines - 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU CHMP Guidelines - 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:EU 2011/C 172/01 - CT-3 11-Jun-2011 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU AMG - Arzneimittelgesetz 19-Jul-2023 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:AUT Question - BASG 11-Feb-2025 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:AUT MPG – Medizinproduktegesetz 26-May-2022 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:AUT FAQ - COVID-19 Studien 15-Mar-2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:AUT BASG - FAQ 11-Feb-2025 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:AUT Ärztegesetz 08-Mar-2023 1 revision imported
• 20:4320:43, 27 June 2026 diff hist 0 m Document:AUT AMG – Arzneimittelgesetz 04-Mar-2023 1 revision imported
• 20:2720:27, 27 June 2026 diff hist −75 Template:ReferenceBox Infobox: table-direct float
• 20:2720:27, 27 June 2026 diff hist −75 Template:DocumentBox Infobox: table-direct float
• 20:2020:20, 27 June 2026 diff hist +1,311 N Template:ReferenceBox Sidebar infobox layout
• 20:2020:20, 27 June 2026 diff hist +93 Template:DocumentBox Sidebar infobox layout
• 20:1420:14, 27 June 2026 diff hist 0 m Reference:DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 - 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:GBR MHRA GCP Inspection Dossier template V7.0 - 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 - 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 - 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 - 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 - 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:DEU Deutsches Ärzteblatt 45849 - 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.2 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 11 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 10 1 revision imported
• 20:0820:08, 27 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8 8.4 1 revision imported