Oversight of Clinical Monitoring: Trends and Strategies

Overview

This online training will be broadcast in Eastern Time (ET)

DIA is pleased to present a three-part online training series focusing on clinical monitor oversight. Hear from experienced faculty on the trends impacting monitors, requirements, approaches, selection, and how to manage a site monitor’s performance. This basic to intermediate level course also focuses on the elements of risk-based monitoring.

Course Level: Intermediate

What you will learn

Trends in the clinical development landscape driving change
ICH and FDA requirements for site monitoring
Current approaches to risk-based monitoring
Warning signs and problems with site monitors
Managing site monitors and their performance
Common errors made in site monitoring
Metrics used to measure site monitor performance

Who should attend?

Clinical research professionals
Professionals who work with or manage site monitors
Sponsors from small-to-mid-size pharmaceutical, biotechnology, and device companies who have clinical operations responsibilities including interaction with sourcing site monitors

Learning objectives

At the conclusion of this course, participants should be able to:

Describe the current factors impacting clinical development necessitating change
Recognize the impact on approaches to risk-based monitoring from FDA Guidance and TransCelerate viewpoints
Identify audit trends and inspection findings relative to site monitoring
Discuss how to develop measurable expectations and objectives for site monitors
Identify best practices in managing site monitors