1/19/2020
SAM Sather and Keith Dorricott co-authored an article published in Clinical Leader entitled, “Clinical Trial Root Cause Analysis: Can't We Do Better Than Five Whys?” If you have experience with Good Clinical Practice (GCP), you may know that ICH E6(R2) now requires sponsors to conduct a root cause analysis (RCA) and implement appropriate corrective and preventive actions (CAPA) for noncompliance “that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results.” You may be familiar with RCA and tools commonly taught and used. One of the RCA tools is the Five Whys method where you ask ‘Why’ five times in an attempt to get to the root cause. The article describes why this is many times not effective and what flaws are apparent. It further describes types of questions that are more helpful at finding root cause(s). RCA is essential to stop recurrence of critical issues, but what if confidence in the results is lacking?
Understanding how to perform effective root cause is critical to planning appropriate CAPA. Unsure what tools to use or what steps to follow? There is a better solution to getting to root cause in a more reproducible way, to developing actions and implementing them. Find out how with the DIGR-ACT® solution!
DIGR-ACT® is a solution for those looking to improve their critical thinking skills in relation to clinical trials and dig further into the root cause. It is developed by industry experts and is a new and an exciting composite of well-tested approaches from other industries synthesized specifically for the clinical trial professional in an eLearning format.
DIGR-ACT® can be purchased as a single license for limited individual use, as a SCORM package for use in your LMS, or can be fully customized to your organization's requirements. After completion of DIGR-ACT®, customizable and scalable in-person training is available to practice and enforce learning objectives based upon your organizations’ training needs.
Want to try an interactive demo of DIGR-ACT®? Click here. To buy the course, click here.
You may also enjoy our blog, “Bye Bye to the Five Whys.”
- The Clinical Pathways Team
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