Oversight of Clinical Monitoring: Trends and Strategies
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.
This On Demand Training will take approximately 6 hours to complete.
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
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