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[Session 2]Exploring the Data Monitoring Enhancement in Clinical Quality Management from Risk-based Approach
Session Chair(s)
Yumi Sugiura, MRCP
Global Clinical Operations, Global Data Management and Centralized Monitoring
Bristol-Myers Squibb K.K., Japan
After 5 years of appearing Risk-Based Monitoring (RBM) approaches to site monitoring, there are some lessons we have learned. One of the most notable changes to ICH E6 (R2) guideline is the quality management recommendations outlined in the Section 5.0, focusing on subject protection and the reliability of the trial results. RBM is part of Quality Management approaches, which can minimize or control risk through proactive risk assessments. This session will explore the value of central monitoring in Data Quality management by enhancing the visualization and leveraging the statistical perspective in additon to the operational risk review.
Speaker(s)
Data Integrity in a Connected World
Jonathan Andrus, MS
CRIO, United States
President and Chief Operating Officer
The Keys to a Successful RBM implementation
Richard Davies
CluePoints, Belgium
VP, Solutions Expert
Potential of Central Monitoring Techniques to Enhance Data Quality
Takeshi Kawakami, MS
Pfizer R&D Japan G.K., Japan
Clincial Data Scientist, Data Monitoring & Management