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Vie-publique.fr - Quelle est la hiérarchie entre les actes administratifs ? +
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Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials. +
Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
Annex 11 Computerised Systems +
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WARNING LETTER - Purolea Cosmetics Lab
MARCS-CMS 722591 +
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WHO - Guidance for best practices for clinical trials +
WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS
Forty-fifth repor +
WHO Good Practices for Clinical Trial Design and Implementation
This course supports understanding and application of key ethical, scientific principles for designing and conducting high-quality, impactful clinical trials. +
WHO guidelines:
- WHO Technical Report Series, No. 850, 1995, Annex 3 ; Guidelines for good clinical practice (GCP) for trials on pharmaceutical products
- Handbook for good clinical research practice (GCP) : guidance for implementation ; 2005 ; ISBN 92 4 159392 X
- Guidance for best practices for clinical trials ; 2024 ; ISBN 978-92-4-009771-1 (electronic version)
+ Definition of standard operating procedures (SOP):
Standard, detailed, written instructions for the management of clinical trials. They provide a general framework enabling the efficient implementation and performance of all the functions and activities for a particular trial as described in this document. +
World Health Organization
WHO Technical Report Series, No. 850, 1995, Annex 3
Guidelines for good clinical practice (GCP) for trials on pharmaceutical products* +
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von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative.
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)statement: guidelines for reporting observational studies.
J Clin Epidemiol. 2008 Apr;61(4):344-9. PMID: 18313558 +
