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Tuesday, June 26 • 2:00pm - 3:15pm
#254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-590-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Rachael Cui Song, MBA


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

ICH E6 (R2): A Miracle Pill for Clinical Research
Stephen Young, MSc

avatar for Mary Arnould

Mary Arnould

Director, Clinical Science Operations, Astellas, United States
Mary Arnould is Director, Center of Excellence & RBM Lead at Astellas Pharma and has been at Astellas over 3 years. She has over 25 years of clinical operations and site monitoring management experience, focusing on RBM implementation since 2014. Mary is currently leading RBM implementation... Read More →
avatar for Rachael Song

Rachael Song

Associate Director - Global Project Management, PPD
Rachael is currently global Project Leader for Oncology clinical trials with focus on Immuno-Oncology and master protocol studies. She has experiences in compound-level clinical planning and design, study-level operational planning and strategy development, and program implementation... Read More →
avatar for Stephen Young

Stephen Young

Chief Scientific Officer, CluePoints
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →

Tuesday June 26, 2018 2:00pm - 3:15pm EDT
Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session