DIA 48th Annual Meeting
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Optimizing Study Monitoring Performance and Efficiency
Track : Track 01: Clinical Operations
Program Code: 374
Date: Wednesday, June 27, 2012
Time: 3:30 PM to 5:00 PM  EST
CHAIR :
 Kenneth Getz, Tufts University, United States
PRESENTER (S):
 Kenneth Getz, Tufts University, United States
 Lisa Rhiner, Clinical Study Lead, PharmaNet/i3 Strategic Resourcing
 Michael Brennan, Johnson & Johnson Pharmaceutical Research & Development, LLC, United States
Description
The global CRA workforce plays a vital role in assessing clinical trial compliance, maintaining relationships with investigative sites, monitoring patient safety and ensuring data quality. During the past decade, study monitor workload has increased and utilization has changed dramatically, with wide variability by geographic region. This symposium explores key characteristics, responsibilities and capacity of the global CRA workforce, notes trends impacting study monitor performance, and explores practices and solutions designed to improve CRA capacity, efficiency and effectiveness.

Learning Objectives:
Review baseline metrics characterizing global CRA workforce workload and utilization
Identify workforce trends and key management issues
Describe monitoring practices that can reduce cycle time, lower work burden and impact efficiency Discuss the impact of data standards on enabling 'real-time' data review.