Root Cause Analysis for GCP – A Risk Action Plan Guide
Every year, millions of dollars are wasted on ineffective management of clinical trials. More often than not, this waste can be addressed with better risk management that includes root cause analysis (RCA) assessments as part of risk mitigation. This course goes beyond root cause techniques, and takes a deeper dive into the factors that must be assessed to ensure effective risk action planning for GCP product development and study management. Course curriculum takes the scientific concepts of root cause analysis and applies them specifically in the clinical trial setting, providing tools that can be used by sponsors/CROs, IRBs/ECs, Investigation Sites and other GCP stakeholders.
During this interactive 120-minute online course, you will learn:
- How to apply root cause analysis in GCP - actionable steps for success
- The most common mistakes made in RCA for GCP and how to avoid them
- How to implement RCA processes that work with sponsors, sites and CROs alike
- RCA for interventions, risk action planning and diagnostic process
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:
- Quality Risk Managers
- CRAs, CRA Managers
- Site Managers, Investigators, CRCs
- Project Managers
- Study Managers
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).