If noncompliance significantly affects trial results, what action should the sponsor take according to ICH E6?

When noncompliance significantly affects trial results, conducting a root cause analysis is essential as outlined in ICH E6. This process involves systematically investigating the circumstances and factors that led to the noncompliance, allowing sponsors to identify underlying issues and understand how they impacted the trial outcomes.

Addressing the root causes helps in devising appropriate corrective and preventive actions to mitigate similar issues in future trials. Additionally, it contributes to maintaining the integrity of the study data, ensuring that reliable findings can be generated and reported. This approach aligns with the principles of protecting the rights of subjects and maintaining data quality and validity, which are critical in clinical research.

While other options may seem viable, they do not adequately address the need for thorough investigation and learning from noncompliance events, which is crucial for the ongoing improvement of clinical trial processes and protection of participant welfare.