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Thursday, June 23 • 9:15am - 9:45am
#403 CH: Who Should Be in the Room to Discuss Risk-Based Quality Management (RBQM) for a Clinical Trial Protocol?

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Component Type: Workshop
Level: Basic

Clinical operations, statistics, medical monitors, and other functions manage portions of a trial. But are they collectively defining critical processes and variables per risk-based quality management as cited by ICH? Who should be in the room?

Learning Objectives

Discuss how Risk-Based Quality Management (RBQM) is more than Risk Based Monitoring (RBM). ICH E6 includes risk identification, evaluation, control, communication, review, and reporting; Describe how clinical operations can drive the discussion, but critical variables and processes are owned by many functions who need to understand, attend, engage and collaborate; Present results of GCP-QA RBQM awareness survey.


Terry Katz, MS

avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Thursday June 23, 2022 9:15am - 9:45am CDT
Room 470 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616