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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 +
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 +
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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 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
Decision from the association of German Ethics Committee concerning the GCP training requirements +
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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 +
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Routemap
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. +
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SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
Publication: Annals of Internal Medicine ; Volume 158, Number 3 +
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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) +
STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9 +
STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS +
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS +
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Soumission CPP à réaliser via la plateforme centralisée avec tirage au sort du CPP +
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Sozialgesetzbuch (SGB) Fünftes Buch (V) - Gesetzliche Krankenversicherung - (Artikel 1 des Gesetzes v. 20. Dezember 1988, BGBl. I S. 2477) +
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The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.
Clinical efficacy and safety guideline categories :
- Alimentary tract and metabolism
- Blood and blood forming organs
- Blood products (including biotechnological alternatives)
- Cardiovascular system
- Dermatologicals
- Genito-urinary system and sex hormones
- Anti-infectives for systemic use
- Antineoplastic and immunomodulating agents
- Rheumatology/musculoskeletal system
- Nervous system
- Respiratory system
- Orally inhaled products
- Radiopharmaceuticals and diagnostic agents
- Allergy/Immunology
- Biostatistics
- General (Including ICH guidelines E1
To be noted:
- INS/GCP/46309/2012 – Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP +
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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.
Selection of publications:
- Clinical research in resource-limited settings (2021)
- Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA – Second Edition (2016)
- Practical Approaches to Risk Minimisation for Medicinal Products: Report of CIOMS Working Group IX (2014)
- International Ethical Guidelines for Epidemiological Studies (2009)
- Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials: Report of CIOMS Working Group VII (2006)
- International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) +
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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 +
The Human Medicines Regulations 2012 +
The Medical Devices Regulations 2002 +
The Medicines for Human Use (Clinical Trials) Regulations 2004 +
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. +
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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 +
