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• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015  + (Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007  + (Guidance for Industry Computerized Systems Used in Clinical Investigations)
• Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013  + (Guidance for Industry Electronic Source Data in Clinical Investigations)
• Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009  + (Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects)
• Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021  + (Guidance on legislation Clinical investigations of medical devices – compiling a submission to MHRA)
• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  + (Guide on Methodological Standards in Pharmacoepidemiology European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP))
• Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024)  + (Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3) (Including NIS))
• Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)  + (Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3))
• Document:INT ISPE - GPP Revision 3 (2015)  + (Guidelines for Good Pharmacoepidemiology Practices (GPP) International Society for Pharmacoepidemiology (ISPE))
• Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005  + (HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) GUIDANCE FOR IMPLEMENTATION)
• Document:GBR HRA - Ending your project 28-Jan-2025  + (HRA - Ending your project)
• Document:ICH ICH E8 Guideline R1 (2021)  + (ICH guideline E8 (R1) on general considerations for clinical studies)
• Document:IMDRF IMDRF – Guidelines -  + (IMDRF: International Medical Device Regula … IMDRF: International Medical Device Regulators Forum </br></br>IMDRF documents - https://www.imdrf.org/documents/library </br>- Technical documents</br></br>Global Harmonization Task Force (GHTF) - https://www.imdrf.org/documents/ghtf-final-documents </br>GHTF Study Group 1 - Pre-market Evaluation</br>GHTF Study Group 2 - Post-market Surveillance/Vigilance</br>GHTF Study Group 3 - Quality Systems</br>GHTF Study Group 4 - Auditing</br>GHTF Study Group 5 - Clinical Safety/Performancetudy Group 5 - Clinical Safety/Performance)
• Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998  + (INFORMATION SHEET Recruiting Study Subjects Guidance for Institutional Review Boards and Clinical Investigators)
• 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  + (INS/GCP/46309/2012 Compliance and Inspections Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP (Inspection reports to EMA 2000-2012))
• Document:GBR IRAS - Integrated Research Application System 28-Jan-2025  + (IRAS: Integrated Research Application System ; provides a single gateway for researchers to apply to the new NIHR Coordinated System for gaining NHS Permissions (NIHR CSP).)
• Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020  + (ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice)
• Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023  + (Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors)
• Document:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007  + (Instruction interministérielle DHOS/E1/DAF/DPACI no 2007-322 et (no DAF/DPACI/RES/no 2007-014) du 14 août 2007 relative à la conservation du dossier médical NOR : SJSH0730928J)
• Document:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3  + (Internal notes: HUMAN DRUG CGMP NOTES (Vo … Internal notes:</br>HUMAN DRUG CGMP NOTES</br></br>(Volume 8, Number 3)</br></br>September, 2000</br></br>(A Memo for FDA Personnel on Current Good Manufacturing Practice For Human Use Pharmaceuticals)</br></br>Issued By: The Division of Manufacturing and Product Quality, HFD-320</br></br>Office of Compliance</br>Center for Drug Evaluation and Research</br>Project Manager: C. Russ Rutledge, HFD-325Project Manager: C. Russ Rutledge, HFD-325)
• Document:ICH ICH Guidelines -  + (International Council for Harmonisation of … International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)</br></br>- Q: Quality guidelines (conduct of </br>stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management, …)</br></br>- S: Safety Guidelines (uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity, non-clinical testing strategy for assessing the QT interval prolongation liability, …)</br></br>- E: Efficacy Guidelines (design, conduct, safety and reporting of clinical trials)</br></br>- M: Multidisciplinary Guidelines (cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology [MedDRA], the Common Technical Document [CTD] and the development of Electronic Standards for the Transfer of Regulatory Information [ESTRI])ransfer of Regulatory Information [ESTRI]))
• Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016  + (International Ethical Guidelines for Health-related Research Involving Humans Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO))
• Document:WHO WHO - ICD 11  + (International Statistical Classification of Diseases and Related Health Problems (ICD))
• Document:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025  + (Investigations cliniques de dispositids médicaux relevant du r`glement européen n°2017/745 Partie II Demande de mise en oeuvre Modalités pratiques)
• Document:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018  + (Leitlinien und Empfehlungen zur Sicherung von Guter Epidemiologischer Praxis (GEP) - Deutsche Gesellschaft für Epidemiologie (DGEpi))

• Document:FRA Constitution du 4 octobre 1958 10-Mar-2024  + (Loi constitutionnelle du 3 juin 1958)

• Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020  + (MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745)
• Document:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021  + (Making changes to a research study to manage the impact of COVID-19)
• Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021  + (Medicines and Medical Devices Act 2021)
• Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0  + (Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training, by Transcelerate Inc.)
• Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024  + (National Cancer Institute GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs)
• Document:GBR National Health Service Act 2006 02-Dec-2019  + (National Health Service Act 2006)
• Document:AUT FAQ - COVID-19 Studien 15-Mar-2021  + (Nationale Regelung zum Quelldatenvergleich aus der Ferne (remote SDV))
• Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013  + (Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Guidance for Industry)
• Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020  + (Part B: Supplementary Information Sheet (S … Part B: Supplementary Information Sheet (SIS)</br>FR Recognition List Number 055 </br></br>Date of Entry 12/21/2020 </br></br>FR Recognition Number 2-282</br>Standard </br>ISO 14155 Third edition 2020-07</br>Clinical investigation of medical devices for human subjects - Good clinical practiceor human subjects - Good clinical practice)
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble  + (Preamble Regulation (EU) 2017/745 (for information))
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble  + (Preamble Regulation (EU) 2017/746 (for information))
• Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble  + (Preamble Regulation (EU) 536/2014 (for information))
• Document:AUT Question - BASG 11-Feb-2025  + (Question by e-mail to BASG staff. E-Mail not disclosed)
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023  + (REGULATION (EU) 2017/745 OF THE EUROPEAN P … REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EECouncil Directives 90/385/EEC and 93/42/EEC)
• Document:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022  + (REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC)
• Document:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025  + (Recherches impliquant la personne humaine … Recherches impliquant la personne humaine mentionnées au 1° de l’article L. 1121-1 du code de la santé publique portant sur des dispositifs</br>médicaux (RIPH1) soumises pour évaluation au CPP et à l’ANSM avant le 26 mai 2021</br>(date d’application du règlement sur les dispositifs médicaux)</br></br>CONDUITE DES INVESTIGATIONS CLINIQUES EN FRANCE</br>Partie II</br>VIGILANCENS CLINIQUES EN FRANCE Partie II VIGILANCE)
• Document:USA Recognized Consensus Standards N.A.  + (Recognized Consensus Standards)
• Document:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023  + (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance))
• Document:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022  + (Regulation (EC) No 178/2002 of the Europea … Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety down procedures in matters of food safety)
• Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22  + (Regulation (EC) No 726/2004 of the Europea … Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)Medicines Agency (Text with EEA relevance))
• Document:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020  + (Regulation (EU) 2016/679 of the European Parliament and of the Council)
• Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016  + (Regulation (EU) 2016/679 of the European P … Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)46/EC (General Data Protection Regulation))
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023  + (Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU)
• Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014  + (Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC)
• Document: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  + (Richtlinie zur Bewertung der Qualifikation … 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 Bundesärztekammer</br></br>Decision from the association of German Ethics Committee concerning the GCP training requirementse concerning the GCP training requirements)