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Root Cause Analysis: Applying the Concept for Better Study Compliance Management August 2010

Course Description

Managing compliance in the research industry is vital to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, intervene, and then evaluate the effectiveness of the intervention.  Without root cause analysis, interventions cannot be effectively identified and designed. Millions of dollars are wasted yearly on ineffective interventions. This course will present the scientific concepts of root cause analysis and apply them specifically in the clinical trial setting. Root cause analysis is invaluable for all stakeholders in clinical research, the sponsor, CRO, site, and IRB.



Learning Objectives

  • Define root cause analysis concepts and definitions
  • Implement Gilbert’s Root Cause Analysis Diagnostic Process
  • Apply root cause in clinical trial study site management
  • Assign the right intervention for successful solutions
  • Proactively use root cause analysis to manage stakeholder compliance: research site management, CRA management, and more

Who Should Attend

  • CRCs
  • CRAs
  • Site Managers
  • CRA Managers
  • Project Managers 


Sandra “SAM” Sather, MS, BSN, CCRA, CCRC

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Course Length Time

2.5 hours; 12:00 - 2:30 p.m. Eastern

Course Dates 

August 26, 2010                                 

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