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Design Considerations, Architecture, and Use of the Mini-Sentinel Distributed Data System

    Basic Details

    This article describes the design, implementation, and feasibility of a large, multiorganizational distributed database developed to support the FDA’s Mini-Sentinel pilot in which contributing organizations retain possession of the source data. The paper focuses on development of a common data model and analytic tools that enable rapid querying of the data locally by data partners.


    Lesley H. Curtis PhD; Mark G. Weiner MD; Denise M. Boudreau RPh, PhD; William O. Cooper MD, MPH; Gregory W. Daniel PhD, MPH; Vinit P. Nair BPharm, MS, RPh; Marsha A. Raebel PharmD; Nicolas U. Beaulieu MA; Robert Rosofsky MA; Tiffany S. Woodworth MPH; Jeffrey S. Brown PhD

    Corresponding Author

    J. S. Brown, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 02215, USA.