The Role of the Study Director in GLP

Abstract

With the complexity of today's studies, it has become increasingly critical that Study Directors understand all disciplines involved in studies under their responsibility. Every phase of a study directly impacts the outcome. If the Study Director does not have sufficient expertise to evaluate problems and issues in all areas as they occur, then study integrity is compromised. The physical location of the Study Director in a multi-site study is of less importance than the education, experience and expertise of that individual. The Study Director must be the single point of control and truly qualified to evaluate all the phases of the study, troubleshoot problems, draw appropriate conclusions, tie all aspects together and write the final report. Copyright © 2006 John Wiley & Sons, Ltd.