FDA noted in a 2013 guidance document that a sponsor should have a “Processes to ensure that root cause analyses are conducted where important deviations are discovered and that appropriate corrective and preventive actions are implemented to address issues identified by monitoring”. Root cause analysis (RCA) is not an inherent activity and requires formal training. While it is important to learn and understand common RCA tools and techniques (e.g., the 5 Whys, Fishbone diagrams), understanding the science of root cause is critical to developing sound corrective and preventative action (CAPA) plans, as well as effective risk assessment action plans. Come to this session and learn, practice and apply this science to create RCA tools specifically useful for both simple and complex clinical trials issues management.
- Define root cause analysis concepts
- Implement Gilbert’s Root Cause Analysis Diagnostic Process
- Apply root cause in clinical trial study site management
- Assign the right intervention for successful solutions
- Apply root cause factors into RCA tools for better intervention assignment