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Published on: September 20, 2019
Findings and recommendations from a root cause analysis of a clinical trial randomization error
Muayad Hamidi1, Omar Abbaas2, Pavan Bhatraju3
1Joe R. and Teressa Lozano Long School of Medicine, University of Texas at San Antonio Health Science Center (UT Health San Antonio), San Antonio, TX, USA.
Journal of Clinical and Translational Science
|June 11, 2026
Summary
A multicenter clinical trial error occurred due to inadequate procedural infrastructure. Root cause analysis identified system failures, leading to corrective actions and new institutional procedures for high-risk studies.
Area of Science:
- Clinical research methodology
- Healthcare systems analysis
- Regulatory compliance in research
Background:
- A National Institutes of Health (NIH)-funded multicenter clinical trial experienced a critical deviation where participants received the incorrect compound due to randomization errors.
- This procedural breakdown highlights vulnerabilities in study-level and institutional oversight within complex research settings.
Purpose of the Study:
- To report a significant procedural error in an NIH-funded clinical trial.
- To conduct a thorough root cause analysis (RCA) to identify systemic failures.
- To implement corrective and preventative actions (CAPA) to mitigate future risks.
Main Methods:
- An independent root cause analysis (RCA) was performed to identify study-level causes of the randomization error.
- Institutional research administration leaders reviewed the RCA findings to pinpoint institution-level causes.
- Consensus was reached to formulate corresponding corrective and preventative actions (CAPA).
Main Results:
- The RCA identified a causal chain involving physical, study-level system, and institution-level system causes.
- Two institution-level CAPAs were developed, establishing procedures for independent verification of critical processes.
- New protocols were implemented for specifying and controlling critical processes in high-risk studies.
Conclusions:
- The absence of robust study-level and institutional procedural infrastructure jeopardized the multicenter study.
- Weaknesses in identifying critical study processes, associated risks, and controls enabled the error.
- Implementing institutional processes for risk identification and control is crucial and may require resource reprioritization.
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