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The Role of the Monitor: Considerations to Adopting a Risk-Based Monitoring System

Mr. Marcus Thornton
Monday, January 12, 2015
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Chapters

  • Introduction
  • Today's Monitoring Model
  • Rebalance Monitoring Activities
  • TransCelerate Looks to Medidata
  • Question #1
  • How We Identify SDV-Driven Data Corrections
  • Question #2
  • How We Identified AEs Found by SDV
  • Findings Will Influence CRA's Role
  • Current Tasks That Must Be Done On-Site
  • Remote Site Monitoring
  • Technology to Enable Remote Monitoring
  • Monitor Roles: Onsite, Remote, Centralized
  • Centralized Monitoring at Small Vs. Large Companies
  • Supporting a Data-Driven Monitoring Approach
  • Site Quality Management (SQM) Example Dashboard
  • Developing a Calculation for Workload: Today
  • Developing a Calculation for Workload: Future
  • Bringing it All Together
  • How Do You Know When You've Reached 1-Day of Work?
  • Visit Schedule for One Site in a Fictional 12-Month Study
  • Conclusion
 

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