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• 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)
• Document:USA 21 CFR Part 54 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 54 Financial Disclosure by Clinical Investigators https://www.ecfr.gov/current/title-21)
• Document:USA 21 CFR Part 50 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 50 Protection of Human Subjects https://www.ecfr.gov/current/title-21)
• Document:USA 21 CFR Part 56 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 56 Institutional Review Boards https://www.ecfr.gov/current/title-21)
• Document:USA 21 CFR Part 812 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter H—Medical Devices Part 812 Investigational Device Exemptions https://www.ecfr.gov/current/title-21)
• Document:USA 21 CFR Part 314 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 314 Applications for FDA Approval to Market a New Drug https://www.ecfr.gov/current/title-21)
• Document:USA 21 CFR Part 320 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 320 Bioavailability and Bioequivalence Requirements https://www.ecfr.gov/current/title-21)
• Document:USA 21 CFR Part 312 09-Apr-2025  + (Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 312 Investigational New Drug Application https://www.ecfr.gov/current/title-21)
• Document:USA 42 CFR Part 11 09-Apr-2025  + (Title 42—Public Health Chapter I—Public Health Service, Department of Health and Human Services Subchapter A—General Provisions Part 11 Clinical Trials Registration and Results Information Submission https://www.ecfr.gov/current/title-42)
• Document:USA 45 CFR Part 160 09-Apr-2025  + (Title 45—Public Welfare Subtitle A—Department of Health and Human Services Subchapter C—Administrative Data Standards and Related Requirements Part 164 Security and Privacy https://www.ecfr.gov/current/title-45)
• Document:USA 45 CFR Part 46 09-Apr-2025  + (Title 45—Public Welfare Subtitle A—Department of Health and Human Services Subchapter A—General Administration Part 46 Protection of Human Subjects https://www.ecfr.gov/current/title-45)
• Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025  + (Transcelerate GCP mutual recognition programm FAQ)
• Document:INT Nuremberg Code 1947  + (Trials of War Criminals Before the Nuernberg Military Tribunals Under Control Council Law No. 10, Nuremberg, October 1946-April, 1949: Case 1: U.S. v. Brandt (cont.) Case 2. U.S. v. Milch (Milch case) Page 181 - 182)
• Document:USA U.S. Code Title 21 30-Sep-2023  + (U.S. Code Title 21 - Food and Drugs)
• Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024  + (Verordnung der Bundesministerin für Gesundheit und Frauen betreffend die besonderen Anforderungen an Ethikkommissionen im Rahmen von multizentrischen klinischen Prüfungen (Leit-Ethikkommissions-Verordnung))
• Document:DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021  + (Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (Strahlenschutzverordnung – StrlSchV))
• Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021  + (Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (Medizinprodukte-Betreiberverordnung – MPBetreibV))
• Document:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022  + (Verordnung über das Verfahren zur Zusammen … Verordnung über das Verfahren zur Zusammenarbeit der Bundesoberbehörden und der registrierten Ethik-Kommissionen bei der Bewertung von Anträgen auf Genehmigung von klinischen Prüfungen mit Humanarzneimitteln*) (Klinische Prüfung-Bewertungsverfahren-Verordnung – KPBV)ung-Bewertungsverfahren-Verordnung – KPBV))
• Document:DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019  + (Verordnung über die Anwendung der Guten He … Verordnung über die Anwendung der Guten Herstellungspraxis bei der Herstellung von Arzneimitteln und Wirkstoffen und über die Anwendung der Guten fachlichen Praxis bei der Herstellung von Produkten menschlicher Herkunft (Arzneimittel- und Wirkstoffherstellungsverordnung – AMWHV)d Wirkstoffherstellungsverordnung – AMWHV))
• Document:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021  + (Verordnung über die Meldung von mutmaßlichen schwerwiegenden Vorkommnissen bei Medizinprodukten sowie zum Informationsaustausch der zuständigen Behörden (Medizinprodukte-Anwendermelde- und Informationsverordnung – MPAMIV))
• Document:FRA Infographie - La hiérarchie des normes 22-Mar-2024  + (Vie-publique.fr - La hiérarchie des normes)
• Document:FRA Guide de légistique 07-Feb-2024  + (Vie-publique.fr - Quelle est la hiérarchie entre les actes administratifs ?)