One of the revisions within the ICH E6 (R2) GCP update specifically notes when there is non-compliance “the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.” Additionally, in 2013 FDA noted in the Risk-based Monitoring (RBM) 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 skill set, and requires formal training and subsequent investigation experience. While it is important to learn and understand common RCA tools and techniques (e.g., the 5 Whys, Fishbone diagrams), the science of root cause analysis is critical to developing sound corrective and preventative action (CAPA) plans, as well as effective risk assessment action plans. By attending this session, you will learn, practice, and apply this science to create RCA tools specifically useful for both simple and complex clinical trials, risk management, and issues management.
During this interactive session, we will:
- 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