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Examining Revisions to the FDA ORA Compliance Program Guidance Manual September 2010

Sep 29, 2010
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Course Description

Clinical Investigator compliance has long been a key metric for assessing the credibility of data obtained from, and the protection of human participants involved in, clinical research. In an effort to increase uniformity in inspections and secure compliance, the FDA has recently reassessed and updated how its investigators inspect Clinical Investigators. This course will examine the new FDA/ORA Compliance Program Guidance Manual and highlight the recent changes and how they reflect the agency’s current focus on assessing the conduct of clinical trials.



Learning Objectives

  • Examine the FDA’s revised approach to evaluating historic noncompliance issues, as well as new areas of concern
  • Describe how information on electronic records and signatures will be assessed during inspections and additional requirements for U.S. Investigators inspected by foreign health authorities
  • Explain how the Clinical Investigator’s responsibilities and interaction with other key clinical research team members will be evaluated

Who Should Attend

  • Clinical Quality Assurance Professionals
  • Clinical Research Associates
  • Project Managers
  • Clinical Investigators
  • Study Coordinators
  • Institutional Officials involved in oversight of clinical research
  • GCP -Focused Regulatory Affairs Professionals


Elizabeth Ronk Nelson, MPH

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Course Length Time

2 hours; 1:00 - 3:00 p.m. Eastern

Course Dates 

September 29, 2010                       

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For more information, contact Naila Ganatra at (215) 413-2471