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Oversight of Clinical Monitoring: Trends and Strategies


Overview

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 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?

  • 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 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