Download or read book Good Practice of Clinical Drug Trials written by Alain Spriet and published by LIBRAIRIE LUGINBUHL. This book was released on 2005 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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