We are updating our Privacy Policy and Terms and Conditions to help you clearly understand how your personal information is collected, stored and managed. Learn More
Menu Back toRisk-Based-Monitoring-for-Master-Protocol-Study-A-Dilemma-and-Possible-Ways-to-Go

DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go

    Session Chair(s)
      Rachael Cui Song, MBA

      Rachael Cui Song, MBA

      • Senior Project Manager - Hematology/Oncology
      • PPD, United States
    Master protocol studies include basket study, umbrella study, platform study, and etc. It provides possibilities to shorten R&D timelines, reduce R&D costs, and improve probability of success if designed and implemented properly. One of the primary key success factors for a master protocol study is the “real-time” collection and analysis of data with high quality to enable “real-time” decision making. Risk-based monitoring (RBM) provides an opportunity to address the needs of data currency and data quality by integrating data-driven risk assessment, statistical monitoring, and data analytics. However there are certain challenges to implement RBM for a master protocol study, due to the more complex design and dynamic nature.
    The session will discuss the opportunity, challenges, and potential ways to apply RBM for a master protocol study.
    Learning Objective : Describe components of a master protocol study and the unique challenges for implementation; Identify the key success factors and challenges to apply risk-based monitoring for a master protocol study.
      Stephen  Young, MSc

      ICH E6 (R2): A Miracle Pill for Clinical Research

      Stephen Young, MSc

      • Chief Operations Officer
      • CluePoints, United States
      Mary  Arnould, BSN, MSN

      Applying Risk-Based Monitoring to Operationally Complex Studies: Opportunities for Improved Quality and Flexibility

      Mary Arnould, BSN, MSN

      • Director, Clinical Science Operations
      • Astellas Pharma Global Development, Inc., United States