The goal of this research is to complete the development of a comprehensive, integrated, flexible, microcomputer software system for clinical trial management capable of managing multiple studies including multi-center protocols. A prototype system developed during Phase I established the feasibility of this type of a software system for clinical trials. Phase II of this research will complete the development of this system by incorporating a relational data base and relational data base language into the prototype software developed during Phase I, enhancing existing modules in the prototype system and adding new modules. The completed software system will have capabilities for protocol definition, data collection and verification, data analysis, reporting, and clinical trail management. This research will result in the commercial availability of economical, microcomputer software for conducting clinical research in a more efficient and cost effective manner in psychopharmacological, pharmaceutical, and medical device research and by individual investigation.
