Auditing Study Reports

Abstract

Final study reports are the culmination of years of intensive labor in the drug development process. Many different styles and presentations are available to sponsors of these activities. The organization, design, formatting, and personnel involved during and after the final study report is written contribute to its clarity and understanding by the regulatory reviewer. This paper illustrates specifically some details which should be considered for the development of a report writing program as well as the extensive quality assurance oversight which is required.