• 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

• 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 activity, 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