Root Cause Analysis (RCA) is a structured method used to identify the underlying cause of a problem rather than only addressing its symptoms.
In clinical research, RCA is commonly used after deviations, audit findings, safety reporting issues, or data integrity concerns to determine why the issue occurred. Effective RCA examines contributing factors such as training gaps, unclear procedures, system limitations, or workload constraints. RCA outcomes typically feed into CAPA to implement corrective actions and prevent recurrence. Strong RCA documentation strengthens quality governance by demonstrating evidence-based problem solving and continuous improvement.