ABSTRACT

This chapter aims to highlight the diversified activities involved in the clinical project coordination function. The clinical project coordination function can provide in one place a readily comprehensible body of interrelated facts, information, forecasts, judgments, and ideas designed to contribute to the most effective decision making by research management. Since drug development is a costly and lengthy program, it is important that clinical project coordination be involved at various intervals of this process. Termination or addition of clinical programs throughout the year are examples of how a forecast's projection can be altered right after release by clinical project coordination. The clinical project coordinator is responsible for distributing the final Clinical Operating Plan for each clinical program to the personnel designated for distribution by research management. The clinical study schedule provides the clinical director and research management with a visual mechanism for monitoring the time elements in a clinical program.