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
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
Alain Spriet, associate professor, clinical pharmacology, university of Paris 5, France. Thérèse Dupin-Spriet, Pharm.D., Senior lecturer, Clinical Pharmacy, Faculty of Pharmacy, University of Lille 2, France.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
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