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• 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)
• Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017  + (Risk proportionate approaches in clinical trials Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use)
• Document:GBR Clinical Trial toolkit 28-Jan-2025  + (Routemap The Clinical Trials Toolkit is an … Routemap</br>The Clinical Trials Toolkit is an interactive colour-coded routemap* to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP). The routemap distinguishes between legal and good practice requirements, and indicates which aspects of these are relevant to wider clinical research in general. It includes an overview of trial practices, along with more detailed information available at 'stations' along the route.n available at 'stations' along the route.)
• Document:N.A. SPIRIT 2013 - Chan et al. 2013  + (SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials Publication: Annals of Internal Medicine ; Volume 158, Number 3)
• Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019  + (STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9 ADDENDUM ON ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS TO THE GUIDELINE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9 (R1))
• Document:ICH ICH E9 Guideline 1998  + (STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9)
• Document:ICH ICH E3 Guideline 1995  + (STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS)
• Document:ICH ICH E7 Guideline 1993  + (STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS)
• Document:FRA SI RIPH 2G - Website 16-May-2025  + (Soumission CPP à réaliser via la plateforme centralisée avec tirage au sort du CPP)
• Document:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988  + (Sozialgesetzbuch (SGB) Fünftes Buch (V) - Gesetzliche Krankenversicherung - (Artikel 1 des Gesetzes v. 20. Dezember 1988, BGBl. I S. 2477))
• Document:EU CHMP Guidelines -  + (The Committee for Medicinal Products for H … The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.</br></br>Clinical efficacy and safety guideline categories :</br>- Alimentary tract and metabolism</br>- Blood and blood forming organs</br>- Blood products (including biotechnological alternatives)</br>- Cardiovascular system</br>- Dermatologicals</br>- Genito-urinary system and sex hormones</br>- Anti-infectives for systemic use</br>- Antineoplastic and immunomodulating agents</br>- Rheumatology/musculoskeletal system</br>- Nervous system</br>- Respiratory system</br>- Orally inhaled products</br>- Radiopharmaceuticals and diagnostic agents</br>- Allergy/Immunology</br>- Biostatistics</br>- General (Including ICH guidelines E1 </br></br>To be noted:</br>- INS/GCP/46309/2012 – Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMPtions conducted at the request of the CHMP)
• Document:CIOMS CIOMS Publications -  + (The Council for International Organization … The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.</br></br>Selection of publications:</br></br>- Clinical research in resource-limited settings (2021)</br>- Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA – Second Edition (2016)</br>- Practical Approaches to Risk Minimisation for Medicinal Products: Report of CIOMS Working Group IX (2014)</br>- International Ethical Guidelines for Epidemiological Studies (2009)</br>- Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials: Report of CIOMS Working Group VII (2006)</br>- International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)l Research Involving Human Subjects (2002))
• Document:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019  + (The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019)
• Document:GBR The Human Medicines Regulations 2012 01-Jan-2025  + (The Human Medicines Regulations 2012)
• Document:GBR The Medical Devices Regulations 2002 11-Feb-2021  + (The Medical Devices Regulations 2002)
• Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004  + (The Medicines for Human Use (Clinical Trials) Regulations 2004)
• Document:GBR NHS: Records Management Code of Practice 07-Aug-2023  + (The Records Management Code of Practice fo … The Records Management Code of Practice for Health and Social Care (from this point onwards referred to as the Code) is a guide for you to use in relation to the practice of managing records. It is relevant to organisations working within, or under contract to, the NHS in England. or under contract to, the NHS in England.)
• Document:USA 21 CFR Part 11 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 11 Electronic Records; Electronic Signatures https://www.ecfr.gov/current/title-21)