Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non-compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non-compliance ensures that the study adheres to GCP and regulatory requirements.
GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.
"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively."
Objectives:
Address non-compliance systematically.
Develop effective CAPA plans.
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