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• Document:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024  + (Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL))
• Document:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021  + (Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form)
• Document:EU CHMP Guidelines -  + (CHMP Guidelines)
• Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016  + (CIOMS - International Ethical Guidelines for Health-related Research Involving Humans)
• Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016  + (CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects)
• Document:CIOMS CIOMS Publications -  + (CIOMS Publications)
• Document:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022  + (COMMISSION IMPLEMENTING DECISION (EU) 2022/729)
• Document:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)  + (CTCAE - Common Terminology Criteria for Adverse Events)
• Document:GBR Clinical Trial toolkit 28-Jan-2025  + (Clinical Trial toolkit)
• Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021  + (Clinical investigations of medical devices – compiling a submission to MHRA)
• Document:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025  + (Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II)
• Document:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025  + (Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II)
• Document:FRA Constitution du 4 octobre 1958 10-Mar-2024  + (Constitution du 4 octobre 1958)
• Document:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018  + (DGEPi - GEP Guter Epidemiologischer Praxis)
• Document:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007  + (DHOS/E1/DAF/DPACI no 2007-322)
• Document:GBR Data Protection Act 2018 06-Jun-2022  + (Data Protection Act 2018)

• Document:WMA Declaration of Helsinki 2024  + (Declaration of Helsinki)

• Document:DEU Deutsches Ärzteblatt 45849  + (Deutsches Ärzteblatt)
• Document:GBR Directive 2001/20/EC 04-Apr-2001  + (Directive 2001/20/EC)
• Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12  + (Directive 2001/83/EC - Community code relating to medicinal products for human use)
• Document:GBR Directive 90/385/EEC 05-Sep-2007  + (Directive 90/385/EEC)
• Document:GBR Directive 93/42/EEC 11-Oct-2007  + (Directive 93/42/EEC)
• Document:GBR Directive 98/79/EC 20-Dec-2011  + (Directive 98/79/EC)
• Document:EU EMA Guidelines -  + (EMA Guidelines)
• Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022  + (EMA/298712/2022 - Complex clinical trials – Questions and answers)
• Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017  + (EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site)
• Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021  + (EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol)
• Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022  + (EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units)
• Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023  + (EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials)
• Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023  + (EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022)
• Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022  + (EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE)
• 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  + (EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic))
• Document:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005  + (EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA)
• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  + (ENCePP - Guide on Methodological Standards in Pharmacoepidemiology)
• Document:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021  + (Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19)
• Document:EU EudraLex – Volume 10 -  + (EudraLex – Volume 10)
• Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011  + (Eudralex - volume 4 GMP Guidelines Annex 11)
• Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011  + (Eudralex - volume 4 GMP Guidelines Chapter 4)
• Document:EUR European Bioethics Convention 1997  + (European Bioethics Convention)
• Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838  + (European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025)
• Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998  + (Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure)
• Document:AUT FAQ - COVID-19 Studien 15-Mar-2021  + (FAQ - COVID-19 Studien)