Which term refers to the written evaluation provided by the sponsor's auditor summarizing the audit results?

• A. Audit Certificate
• B. Audit
• C. Audit Trail
• D. Audit Report

Answer: (D)

The main idea is the formal written summary of what the audit found. When a sponsor’s auditor reviews a site or study process, the document that communicates the findings, conclusions, and any recommendations is the audit report. It consolidates observations, indicates whether procedures met GCP and regulatory requirements, and often includes actions needed to address any deficiencies (CAPA).

An audit is the activity of examining compliance, not the written product. An audit trail is the chronological record of data changes that helps verify integrity, not a summary of audit results. An audit certificate would imply a certification of compliance or passing, which isn’t the standard document used to summarize audit findings in GCP contexts.