Which document confirms that all activities required for trial close-out are completed and copies of essential documents are filed?

• A. Treatment Allocation and Decoding Documentations
• B. Record of Retained body Fluids
• C. Audit Certificate
• D. Final Trial Close-Out Monitoring Report

Answer: (D)

Documenting trial close-out activities means having a formal record that all required tasks for winding down the trial are completed and that copies of essential documents are properly filed. The Final Trial Close-Out Monitoring Report serves exactly that purpose. It is the report produced at the end of monitoring and trial activities and confirms that all close-out steps—such as resolving open data queries, ensuring data integrity, confirming data lock status, and filing essential documents in the trial master file or archive—have been completed. This report provides an auditable endpoint for the trial and supports regulatory compliance by showing the trial has been properly closed and records are retained as required. Other documents listed do not specifically certify completion of close-out activities and filing of essential documents.