The design and implementation of a software system for clinical studies: an illustration based on the needs of a comprehensive cancer center.

A computerized system for the management of a clinical research database has been developed with several attractive features. This relational database management system allows for screen-driven data entry, data checking, system security, and report generation in a timely manner. In addition, the system is cost-effective in a number of ways: (1) development time is considerably reduced due to the inherent programming features of the software, (2) once developed the system can be maintained by nontechnical personnel thereby reducing personnel costs, (3) the system can be developed and maintained on a microcomputer system, and (4) the commercial software used in our system is periodically updated thereby assuring the user of state-of-the-art technology. Beyond the initial expenditures for hardware and software, no additional system costs are incurred. While this system, currently adopted by the Yale Comprehensive Cancer Center, represents an effective approach to handling the data-management needs of a large, single-institution cancer research center, the design and programming methodology can be readily adapted to other research settings.