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DIA 2018 Global Annual Meeting

The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan

    Session Chair(s)
      Linda B. Sullivan, MBA

      Linda B. Sullivan, MBA

      • Co-Founder and President
      • Metrics Champion Consortium LLC, United States
    This session shares how group of sponsors, CROs,and RBM/data analytic vendors have explored centralized monitoring data/metric use and describes a centralized monitoring plan template that supports implementation of centralized monitoring.
    Learning Objective : Explain how centralized monitoring supports the quality management approach of ICH E6 (R2); Describe some key items to consider as you develop your centralized monitoring plan; Compare key items in the centralized monitoring plan template with items in your centralized monitoring plans.
      Nurcan  Coskun, PhD, MSc

      To be determined

      Nurcan Coskun, PhD, MSc

      • Global Risk Based Monitoring Program and Technology Solutions Manager | MC2
      • Medtronic International Trading Sàrl, Switzerland
      Keith  Dorricott

      To be determined

      Keith Dorricott

      • MCC Ambassador; Director
      • Dorricott Metrics and Process Improvement Ltd. , United Kingdom
      Olgica  Klindworth

      To be determined

      Olgica Klindworth

      • Associate Director, Data Analytics
      • PPD, Inc., United States