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Short description of the document.
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Medicines and Medical Devices Act 2021 +
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Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training, by Transcelerate Inc. +
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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 +
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National Health Service Act 2006 +
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Nationale Regelung zum Quelldatenvergleich aus der Ferne (remote SDV) +
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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 +
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055
Date of Entry 12/21/2020
FR Recognition Number 2-282
Standard
ISO 14155 Third edition 2020-07
Clinical investigation of medical devices for human subjects - Good clinical practice +
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Preamble Regulation (EU) 2017/745 (for information) +
Preamble Regulation (EU) 2017/746 (for information) +
Preamble Regulation (EU) 536/2014 (for information) +
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Question by e-mail to BASG staff.
E-Mail not disclosed +
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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/EEC +
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 +
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FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 +
Recherches impliquant la personne humaine mentionnées au 1° de l’article L. 1121-1 du code de la santé publique portant sur des dispositifs
médicaux (RIPH1) soumises pour évaluation au CPP et à l’ANSM avant le 26 mai 2021
(date d’application du règlement sur les dispositifs médicaux)
CONDUITE DES INVESTIGATIONS CLINIQUES EN FRANCE
Partie II
VIGILANCE +
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Recognized Consensus Standards +
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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) +
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 +
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 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) +
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Regulation (EU) 2016/679 of the European Parliament and of the Council +
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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) +
