Findings and Recommendations from a Root Cause Analysis of a Clinical Trial Randomization Error: A Case Report

Introduction: Participants in NIH-funded multicenter clinical trial received the compound opposite to the randomization intention. We report the problem, subsequent root cause analysis (RCA) and corrective and preventative action (CAPA). Methods: The RCA was independently facilitated to identify study-level causes of the problem. Results were reviewed by institutional research administration leaders to identify institution-level causes and formulate corresponding CAPA. Both culminated in consensus. Results: The resulting causal chain consisted of two physical causes, two study-level system causes, and two institution-level system causes for which two institution-level CAPAs were formulated by institutional leadership. The CAPAs established institutional procedures for independent verification of critical processes, their specification, and their planned control on high-risk studies. Conclusions: Lack of study-level procedural infrastructure jeopardized a multicenter study led by our institution. Lack of institutional infrastructure supporting identification of critical study processes, risks to them, and appropriate controls enabled the problem to occur. Studies conducted in settings lacking institutional or study-level procedural infrastructure are susceptible to similar problems. Adding the needed institutional processes to support identification of critical study processes, risks to them, and appropriate controls required reprioritizing existing resources.