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List of results

• Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023  + (EU)
• Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023  + (EU)
• Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022  + (EU)
• 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  + (EU)
• Document:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005  + (EU)
• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  + (EU)
• Document:EU EudraLex – Volume 10 -  + (EU)
• Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011  + (EU)
• Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011  + (EU)
• Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022  + (EU)
• Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)  + (EU)
• Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024)  + (EU)
• 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  + (EU)
• Document:EU MDCG Guidelines -  + (EU)
• Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017  + (EU)
• Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22  + (EU)
• Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016  + (EU)
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble  + (EU)
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023  + (EU)
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble  + (EU)
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023  + (EU)
• Document:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022  + (EU)
• Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble  + (EU)
• Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014  + (EU)
• Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12  + (EU)
• Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838  + (EU)

• Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020  + (EU ; GBR)
• Document:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023  + (EU ; GBR)
• Document:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022  + (EU ; GBR)

• Document:EUR European Bioethics Convention 1997  + (EUR)
• Document:FRA AEC DOC010 V.04 01-Jun-2018  + (FRA)
• Document:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025  + (FRA)
• Document:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025  + (FRA)
• Document:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024  + (FRA)
• Document:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025  + (FRA)
• Document:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025  + (FRA)
• Document:FRA Constitution du 4 octobre 1958 10-Mar-2024  + (FRA)
• Document:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007  + (FRA)
• Document:FRA Guide de légistique 07-Feb-2024  + (FRA)
• Document:FRA Infographie - La hiérarchie des normes 22-Mar-2024  + (FRA)
• Document:FRA SI RIPH 2G - Website 16-May-2025  + (FRA)
• Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025  + (FRA)
• Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021  + (GBR)
• Document:GBR Clinical Trial toolkit 28-Jan-2025  + (GBR)
• Document:GBR Data Protection Act 2018 06-Jun-2022  + (GBR)
• Document:GBR Directive 2001/20/EC 04-Apr-2001  + (GBR)
• Document:GBR Directive 90/385/EEC 05-Sep-2007  + (GBR)
• Document:GBR Directive 93/42/EEC 11-Oct-2007  + (GBR)
• Document:GBR Directive 98/79/EC 20-Dec-2011  + (GBR)
• Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020  + (GBR)
• Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447  + (GBR)
• Document:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021  + (GBR)
• Document:GBR HRA - Ending your project 28-Jan-2025  + (GBR)