Reengineering a database for clinical trials management: Lessons for system architects

This paper describes the process of enhancing Trial/DB, a database system f or clinical studies management. The system's enhancements have been driven by the need to maximize the effectiveness of developer personnel in support ing numerous and diverse users, of study designers in setting up new studie s, and of administrators in managing ongoing studies. Trial/DB was original ly designed to work over a local area network within a single institution, and basic architectural changes were necessary to make it work over the int ernet efficiently as well as securely. Further, as its use spread to divers e communities of users, changes were made to let the processes of study des ign and project management adapt to the working styles of the principal inv estigators and administrators for each study. The lessons learned in the pr ocess should prove instructive for system architects as well as managers of electronic patient record systems. (C) Elsevier Science Inc. 2000.