Good Practice of Clinical Drug Trials PDF

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Téléchargez la version électronique de Good Practice of Clinical Drug Trials sur accentsonline.fr. Formats disponibles : Good Practice of Clinical Drug Trials PDF, Good Practice of Clinical Drug Trials ePUB, Good Practice of Clinical Drug Trials MOBI

This new edition of "Good Practice" is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: Rationale for each rule presented ; Safety of data in clinical trials ;Protection of personal data ; Conflicts of interest ; Measures to be taken in case of suspected fraud

INFORMATION

TAILLE DU FICHIER 8,26 MB
AUTEUR Alain Spriet
DATE DE PUBLICATION 2004-Jul-01

Good Clinical Practice | FDA - U.S. Food and Drug ...

Good clinical practice (GCP) is an international quality standard for conducting clinical trials that in some countries is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.. GCP follows the International Conference on Harmonisation of Technical Requirements for Registration ...

PDF Good Clinical Practice (GCP).

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. 1 Regardless of whether a clinical trial is a large, multi-centre study in patients or a small clinical pharmacological study in healthy subjects, the relevant GCP standard should be ...

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