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. This web seminar 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 Institutional Review Board (IRB).
- Define root cause analysis concepts
- Implement Gilbert’s Root Cause Analysis Diagnostic Process
- Apply root cause analysis 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, Clinical Research Associate (CRA) management, and more
- Clinical Research Coordinators
- Clinical Research Associates
- Site Managers
- Clinical Research Associate Managers
- Project Managerss
Gary B. Freeman, M.S., C.C.R.A.
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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.