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Risk-Based Monitoring Symposium

Track:
Clinical Operations

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
326

Room Number:
2

Level:
Intermediate

Type:
Symposium

Title:
Risk-Based Monitoring Symposium

Chair(s):
Marcus Thornton
Senior Director, CTMS
Medidata Solutions Worldwide, United Kingdom

Description:
Life science organizations are actively implementing and executing risk-based monitoring programs, but what will this mean for current onsite monitoring practices and how will this shape the role of a clinical research associate (CRA)? This symposium will examine practical approaches to building a site management and monitoring team that supports a risk-based program and discuss how today's functional monitoring role might evolve.


Learning Objective(s):
Assess how onsite and remote monitoring and centralized site quality management functions are influenced by technology, analytics, and benchmarks; Demonstrate a model for collaboration between data managers and CRAs that optimizes site performance and delivers higher quality site captured data at a lower cost; Discuss how to evolve from the traditional CRA role into a risk-based monitoring world where there is interplay between remote, central, and onsite monitoring activities.

Presentation(s) & Speaker(s):
The Role of the Monitor: Considerations to Adopting a Risk-Based and Adaptive Monitoring Program
Marcus Thornton
Senior Director, CTMS
Medidata Solutions Worldwide, United Kingdom

Occupying the White Space Between the Clinical Data Manager and the Clinical Research Associate
Dermot Kenny
Executive Vice President, Global Clinical and Data Operations
ICON, Ireland

De-Risking Your Risk-Based Monitoring (RBM) Plan: Practical Considerations in Implementing RBM at the CRA Level
Rita Purvis
Vice President, Clinical Operations
inVentiv Health Clinical, United States