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 fraudAn overall review by a single reviewer thus, is useful to ensure a certain uniformity of content for the entire brochure. ... draft or a final version. lf such information is certain with respect to content and provisional in format ( unwritten final report), anbsp;...
|Title||:||Good Practice of Clinical Drug Trials|
|Author||:||Alain Spriet, Thérèse Dupin-Spriet|
|Publisher||:||LIBRAIRIE LUGINBUHL - 2005-01-01|