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The Organizational Structure and Governing Principles of the Food and Drug Administration's Mini-Sentinel Pilot Program

    Basic Details

    This article describes the development of an organizational structure, as well as principles and policies, to govern the operations of the Mini-Sentinel pilot program. It describes the program's coordinating center and key principles and policies.


    Susan Forrow BA; Daniel M. Campion MBA; Lisa J. Herrinton PhD; Vinit P. Nair BPharm, MS, RPh; Melissa A. Robb RN; Marcus Wilson PharmD; Richard Platt MD, MSc

    Corresponding Author

    S. Forrow, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, 401 Park Drive, Suite 401 East, Boston, MA 02215, USA. Email: