What do automotive assembly lines and modern clinical trials have in common? More than many people realize. As the clinical research enterprise implements the International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice, clinical research teams are increasingly expected to apply concepts such as Quality by Design, Risk-Based Quality Management, Root Cause Analysis, and proactive risk mitigation, many of which originated from manufacturing quality systems.

This session will translate these concepts into practical applications for clinical research professionals by exploring how “factory tools” like the 5 Whys and Fishbone (Ishikawa) diagrams can strengthen Corrective and Preventive Action plan development, improve operational workflows, and support inspection readiness. Through real-world examples, attendees will learn how to move beyond superficial findings such as “human error” to identify true systemic contributors to noncompliance and quality issues while preserving the human-centered nature of clinical trials and participant safety oversight.

CEU: 1.0 ACRP

Speaker:

• Asma Khan, MS, MBBS, CCRC, CCRP, Associate Director, PRMS & Quality, Stanford Cancer Institute