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Oversight of Clinical Monitoring: Trends and Strategies

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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.

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 TranCelerate viewpoints
  • Identify sponsor responsibilities relative to site monitoring, including oversight
  • 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

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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