Monitoring/ Monitoring Effectiveness
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2024 Agenda
Fri., Sept. 27 1:15 to 2:00 Track: Monitoring / Monitoring Effectiveness
Effective Strategies for an Entry Level Clinical Research Associate/Monitor
Ms. Mahanti will discuss what tools and resources new clinical research monitors can use to make their lives easier. 809
Presenter: Harshini Mahanti, MSc, CCRP, Senior Clinical Research Monitor, University of Miami
Fri., Sept. 27 2:05 to 2:50 Track: Monitoring / Monitoring Effectiveness
Monitoring Sponsor-Investigator Protocols: Lessons Learned from FDA Inspections
Monitoring of clinical trials is a pivotal aspect of quality control. Successful FDA inspections are often realized due to robust monitoring practices targeting specific components of subject protection, product management, and regulatory affairs. 811
Presenter: Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center
Fri., Sept. 27 3:25 to 4:10 Track: Monitoring / Monitoring Effectiveness
Optimizing Clinical Research Monitoring
Ms. Surdam will explore the nuances of central, remote, and risk-based monitoring to highlight the similarities, differences, and unique challenges of each. How to unlock the full potential of each monitoring approach individually and gain insight into the benefits of utilizing several techniques concurrently to effectively enhance monitoring strategies across the board will be discussed. 813
Presenter: Kristin Surdam, MS, PMP, CCRC, Senior Director, KOL & Strategy, Florence Healthcare
Fri., Sept. 27 4: 15 to 5:00 Track: Monitoring / Monitoring Effectiveness
Inspection Readiness: Are You Ready?
Mr. Wise will consider practical and useful recommendations on how to prepare for inspections and ensure proper monitoring of investigations. Not simply regurgitating the regulations but reading between the lines to understand the 'why' and to make smart, proactive choices throughout the clinical trial lifecycle. 815
Presenter: Andy Wise, BA, CCRC, CCRA, Staff Clinical Compliance Auditor, Beckman Coulter Inc.