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List of results

• Document:AUT Ärztegesetz 08-Mar-2023  +
• Document:AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021  +
• Document:AUT BASG - FAQ 11-Feb-2025  +
• Document:AUT FAQ - COVID-19 Studien 15-Mar-2021  +
• Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024  +
• Document:AUT Question - BASG 11-Feb-2025  +
• Document:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021  +
• Document:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021  +
• Document:EU 2011/C 172/01 - CT-3 11-Jun-2011  +
• Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017  +
• Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021  +
• Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022  +
• Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023  +
• Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023  +
• Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022  +
• Document:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018  +
• Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011  +
• Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011  +
• Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022  +
• Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024)  +
• Document:EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012  +
• Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016  +
• Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014  +
• Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12  +
• Document:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023  +
• Document:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022  +
• Document:EUR European Bioethics Convention 1997  +
• Document:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024  +
• Document:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025  +
• Document:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025  +
• Document:FRA Constitution du 4 octobre 1958 10-Mar-2024  +
• Document:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007  +
• Document:FRA Guide de légistique 07-Feb-2024  +
• Document:FRA Infographie - La hiérarchie des normes 22-Mar-2024  +
• Document:GBR Clinical Trial toolkit 28-Jan-2025  +
• Document:GBR Data Protection Act 2018 06-Jun-2022  +
• Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447  +
• Document:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021  +
• Document:GBR HRA - Ending your project 28-Jan-2025  +
• Document:GBR IRAS - Integrated Research Application System 28-Jan-2025  +
• Document:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021  +
• Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021  +
• Document:GBR National Health Service Act 2006 02-Dec-2019  +
• Document:GBR NHS: Records Management Code of Practice 07-Aug-2023  +
• Document:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025  +
• Document:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019  +
• Document:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020  +
• Document:USA 21 CFR Part 11 09-Apr-2025  +
• Document:USA 21 CFR Part 50 09-Apr-2025  +
• Document:USA 21 CFR Part 54 09-Apr-2025  +