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Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders
Session Chair(s)
Mary Banach, PHD, MPH
Retired Instructor, Dept. of Biostatistics
DIA CDM Community, United States
This workshop will allow attendees to look at terms defined by regulatory authorities and to compare and contrast the understanding of risk-based monitoring (RBM) from the perspectives of the various stakeholders. We will use practical examples.
The DIA CDM and RBM Communities have been working on a project that creates a concrete ‘Roadmap’ for companies on how to implement ‘RBM’ - or more generally how to implement a data backbone in the organization that would allow the different functions (data management, pharmacovigilance, medical monitoring, operations, regulatory, etc.) to leverage the appropriate data collected/generated by CDM and other functions as indicators to identify critical risks in their specific area.
Learning Objective : Define risk-based monitoring (RBM) from different stakeholders’ perspectives: data management, pharmacovigilance, medical monitoring, operations, and regulatory; Compare and contrast terms used in RBM from different stakeholders’ perspectives; Review the major difficulties encountered in each phase of developing an RBM program.
Speaker(s)
Where We Are: Where We Are Going
Steve Young, MSC
CluePoints, United States
Chief Scientific Officer
Vendor Selection for Risk-Based Monitoring
Nimita Limaye, PHD
IDC, United States
Research VP, Life Sciences R&D Strategy and Technology, at IDC