Experience Using Standard Software to Provide a Comprehensive Information Processing System for a Large and Complex Clinical Study

摘要

In this paper, we describe how we used a standard database management system (System 2000) and a computer utility to build a sophisticated medical records system in support of a national multi-clinic clinical trial. Privacy, protocol adherence, quality control and other key elements of an ethical clinical trial were satisfied at a fraction of the development cost for the more traditional approach of building a customized system. We feel that old lessons learned in other areas regarding the balance of manual to automated systems and the use of standard software are applicable to medical information systems. Neither a medical setting nor a clinical experiment changes the basic issues of good systems design. Operating and efficiency statistics gathered during two years of system production operation are presented.