Developing an Internal Audit System — An Investigator's Experience

Abstract

Experience has shown that haphazard attempts at enforcing quality can have a detrimental effect on research teams already tied down by regulatory red tape. What is needed is an internal audit system built into the research process—a system that allows the research process to take shape around it. This article describes such an audit system — one which after suffering the usual teething problems and proving its worth time and again became intimately accepted by the entire clinical research team.