Development of a Human Subjects Information System

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The University of Wisconsin is seeking funds through this unique funding opportunity to develop and implement a comprehensive human subjects information system that will enhance the overall performance of all components of the human subjects research enterprise on campus, from individual investigators to institutional oversight groups. Various initial efforts have served to define the overall process taking into consideration requisite information, data flow patterns and utilization. The ultimate objective of this exercise is the generation and deployment of a flexible information system that will permit real-time sharing of human subjects data that currently resides on various independent systems dispersed across all campus units involved in human subjects research, clinical trial performance or grants/financial administration. Ideally, the proposed system will also accommodate inclusion of additional fields currently unavailable in existing databases; will streamline data entry; will reduce the clerical workload currently shouldered by the staff of the human subjects offices thereby increasing their availability for other activities that would serve to enhance the overall system for human subjects protection (investigator education for example); will provide an easily searchable and sortable environment; and will facilitate notification and report generation. The project will be directed by a Project Planning Committee (PPC) consisting of representatives from key units involved in the human subjects protection program at the UW. Once developed the information system will be made available at no cost to other University of Wisconsin System colleges for application in their human subjects protection systems.