A root cause analysis should be:

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.