Database management for clinical trials

ABSTRACT

The Authors describe how they 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. The authors feel that old lessons learned in other areas regarding the balance of manual to automated systems and the use of standard software are being re-learned for clinical trials. Neither a medical setting nor a clinical experiment changes the basic issues of good systems design. The possibility of using clinical trials as a test bed for developing medical information systems is also proposed.