Final FDA Guidance for Supervisory Responsibilities of Investigators: What Made it Through and How It Affects Sites and Sponsors February 2011

Feb 16, 2011
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Course Description 

This course presents content and impact discussion of the now FINAL FDA human subject protection guidance document posted in May 2007 and approved October 2009. The guidance document addresses definitions of adequate supervision, appropriate oversight and delegations, adequate training, proper credentialing by principal investigators, and reasonable medical care and access to appropriate care for study subjects. The seminar addresses how the guidance provides long awaited counseling on activities of the principal investigator regarding working with their study team and how the guidance impacts greatly on the role of the sponsor in qualifying and monitoring the research site.



Learning Objectives 

  • Recognize the history of the guidance draft and final releases
  • Analyze the two major content areas of the guidance for the clarification of certain investigator responsibilities
  • Examine implications on site and sponsor activities
  • Explore case scenarios: recent warning letters and more

 Who Should Attend 

  • Clinical Research Investigators
  • Clinical Research Coordinators
  • Clinical Research Associates
  • Managers
  • Quality Assurance


Sandra "SAM" Sather, MS, BSN, CCRA, CCRC

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Course Length Time 

1.5 hours; 12:00 - 1:30 p.m. Eastern

Course Dates 

February 16, 2011

mail ACPE statements within three weeks of program completion.  ACPE#: 778-000-09-053-L04-P. Released: 1/10.                                               

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