You have probably heard about the changes to the ICH E6 GCP, the R2 addendum, and that it impacts clinical trial oversight. One particularly important section added was in ICH E6 (R2) 5.20.1: “If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.” Now it is clear that root cause analysis (RCA) and a corrective and preventive action plan (CAPA) are in order for issues that matter. But, the efficacy of the actions relies on getting the right root cause(s). Are you sure you can discover the real root cause(s)?
Think about this scenario. A study participant is administered with the wrong dose of investigational product with potentially serious consequences. On root cause analysis, it is discovered that the pharmacist had made an error and provided the wrong dose. They were reminded to review the protocol and follow the details exactly. But, a month later, the same issue recurred. This time with a different pharmacist. As it turned out, further root cause analysis uncovers this has happened at other sites too.
So, what was wrong with the first investigation? Did they really get to root cause? No, they needed to take a broader view. Had this happened before? Had it happened elsewhere? Was it simply a slip by the pharmacist, and if so, couldn’t the same happen again – even if they have received a reminder?
Back to our question of, “How can you be sure you can discover the right root cause?” RCA is not an intuitive process, and it requires some guidance. DIGR-ACT® is a solution that supports confidence and decision making for effective issues actions selection. It was developed by industry experts through a collaboration with Clinical Pathways, LLC and Dorricott Metrics & Process Improvement Limited. Going through the DIGR-ACT® steps guides you through the process to ask the right questions and effectively address the right issues.
- The Clinical Pathways Team
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