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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
TAILLE DU FICHIER | 4,37 MB |
AUTEUR | Alain Spriet |
DATE DE PUBLICATION | 2004-Jul-01 |
Introduction --Bad clinical practices --Good clinical practices --Protection of participants --Writing the protocol --Designing the case report forms --Monitoring of clinical trials --Data management --Drug manufacturing --Drug packaging --Drug labelling --Test drug: in use --Clinical laboratory data --Adverse events --Trial report --Filing and archiving --Audit and inspection.
Introduction --Bad clinical practices --Good clinical practices --Protection of participants --Writing the protocol --Designing the case report forms --Monitoring of clinical trials --Data management --Drug manufacturing --Drug packaging --Drug labelling --Test drug: in use --Clinical laboratory data --Adverse events --Trial report --Filing and archiving --Audit and inspection.