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Framework for Assessment of Positive Results from Signal Refinement

    Basic Details

    Medical product post-market safety surveillance can be conceptualized as a three stage process involving signal generation, signal refinement, and signal evaluation. This article describes a framework developed by the Mini-Sentinel pilot study for signal refinement, which involves the assessment of predefined exposure-outcome pairs to determine whether there is an association


    David L. McClure PhD, Marsha A. Raebel PharmD, W. Katherine Yih PhD, MPH, Azadeh Shoaibi PhD, MHS, MS, Jerald E. Mullersman MD, PhD, MPH, Colin Anderson-Smits MPH, Jason M. Glanz PhD

    Corresponding Author

    D. McClure, Epidemiology Research Center/ML2, Marshfield Clinic Research Foundation, 1000 North Oak Avenue, Marshfield, WI 54449, USA. E-mail: