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.
- 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
- Clinical Research Investigators
- Clinical Research Coordinators
- Clinical Research Associates
- Managers
- Quality Assurance
Sandra "SAM" Sather, MS, BSN, CCRA, CCRC
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1.5 hours; 12:00 - 1:30 p.m. Eastern
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.