What action should be taken with safety updates and periodic reports?

• A. Submit to regulatory authorities as required
• B. Delete after a year
• C. Ignore unless requested
• D. Share only within the sponsor's team

Answer: (A)

Safety reporting to regulatory authorities is a fundamental responsibility in GCP. Updates on safety findings and periodic safety reports are not for internal review alone; they are required communications to regulators to enable ongoing assessment of risk and benefit. The sponsor or their designee must ensure these safety updates are submitted promptly and in the manner and timeline specified by applicable regulations, so participant protection and regulatory oversight are maintained. Deleting records after a year would breach retention requirements, ignoring safety information undermines protection, and sharing only within the sponsor’s team would fail to meet regulatory communication duties. Therefore, submitting to regulatory authorities as required is the correct action.