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

Sign up or log in to save this to your schedule and see who's attending!

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 Pharma Global Development, Inc.
Mary has been in the pharmaceutical industry for over 20 years. She began her career as a site monitor and monitored studies in numerous therapuetic areas. Mary managed site monitors for over 10 years. She has been supporting the implementation of Risk Based Monitoring at Bristol... 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 Operations Officer, CluePoints
As CluePoints COO, Steve is primarily responsible for ensuring successful customer adoption of the CluePoints platform. Steve worked for three bio-pharma companies over a span of 15 years where he assumed leadership positions in data management and led the successful enterprise roll-out... Read More →

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