Which document is used to document that an audit was performed, if available?

Which document is used to document that an audit was performed, if available?

• A. Final Trial Close-Out Monitoring Report
• B. Signature Sheet
• C. Completed Subject Identification Code List
• D. Audit Certificate

Answer: (D)

Documenting that an audit occurred is about formally attesting that an independent evaluation took place. An Audit Certificate serves as that formal confirmation, outlining the audit's occurrence, scope, date, and the parties responsible. When an audit certificate is available, it provides clear evidence to sponsors, regulators, or QA teams that the audit was performed and by whom. Other documents mentioned serve different purposes: a Final Trial Close-Out Monitoring Report summarizes monitoring activities at trial close-out, a Signature Sheet records signatures or acknowledgments, and a Completed Subject Identification Code List relates to subject privacy coding. They do not document that an audit occurred.

Documenting that an audit occurred is about formally attesting that an independent evaluation took place. An Audit Certificate serves as that formal confirmation, outlining the audit's occurrence, scope, date, and the parties responsible. When an audit certificate is available, it provides clear evidence to sponsors, regulators, or QA teams that the audit was performed and by whom.

Other documents mentioned serve different purposes: a Final Trial Close-Out Monitoring Report summarizes monitoring activities at trial close-out, a Signature Sheet records signatures or acknowledgments, and a Completed Subject Identification Code List relates to subject privacy coding. They do not document that an audit occurred.