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 attendting 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:
This course will be of benefit to anyone involved in the clinical trial process. Those involved in the following disciplines will find this training particularly helpful:
Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC). She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).