What action must the sponsor take if noncompliance is identified according to ICH E6?

When a sponsor identifies noncompliance according to ICH E6 guidelines, the appropriate action is to perform a root cause analysis. This is essential for understanding the underlying reasons behind the noncompliance, which enables the sponsor to develop effective corrective and preventive actions. Identifying and analyzing the root causes ensures that similar issues are less likely to recur, thereby upholding the integrity of the clinical trial data and ensuring participant safety.

A root cause analysis allows the sponsor to engage thoroughly with the situation, leading to actionable insights rather than just addressing symptoms of the problem. This systematic approach aligns with GCP principles, promoting a culture of continuous improvement and compliance with regulations.

Taking such proactive measures reflects the sponsor's commitment to maintaining compliance and ensuring the quality of the trial, which is crucial for successful regulatory submissions and ultimately for the safety and well-being of study participants.