Implications of the New FDA Guideline for a Risk-Based Approach to Monitoring July 2012

Jul 16, 2012
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Course Description

The FDA’s Guideline for the Monitoring of Clinical Investigations (1988-2010) has been removed from the FDA list of guidance documents. Instead, the FDA has released an updated version of the Bioresearch Monitoring (BIMO) Compliance Program Guidance Manual for Sponsor/CRO and Monitoring, and most recently the agency released a draft guidance to reflect their expectations and recommendations related to monitoring investigation sites, monitoring systems, and investigative site oversight. In this web seminar, the content and the implications to sponsor monitoring and clinical investigation sites will be discussed.


Learning Objectives

  • Explain ways in which the regulatory climate is reflected in the new monitoring guideline
  • Discuss the content of the guideline in relation to traditional monitoring plans
  • Assess the implications of the guideline to current monitoring practices and relationships with oversight of Clinical Investigator

Who Should Attend

  • Clinical Research Associates
  • Study and Clinical Research Associate Managers
  • Clinical Investigators and Staff
  • Sponsors/CROs Clinical Operations
  • Clinical Quality Compliance and Quality Assurance Professionals


Nikki Christison, B.S. 

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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 


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