Good Clinical Practice (GCP) Practice Exam

What does an audit certificate confirm?

1. A declaration of confirmation by the auditor that an audit has taken place

2. A summary of the audit findings

3. An estimate of future audit costs

4. A list of trial participants

The correct answer is: A declaration of confirmation by the auditor that an audit has taken place

An audit certificate serves as a formal declaration from the auditor indicating that an audit has been conducted. This document confirms that the auditor has performed their review in accordance with applicable standards and regulations, helping to establish credibility and assurance regarding the audit process. The certificate typically encompasses the auditor's findings and whether the audited entity complies with the relevant guidelines or frameworks. In the context of clinical trials and good clinical practice, obtaining an audit certificate is a critical step in demonstrating that proper protocols have been followed, which is essential for the integrity of the study and the reliability of its outcomes. It is not merely a summary of findings, an estimate of future costs, or a list of trial participants, as those serve different purposes and would not convey the formal confirmation that the audit has occurred and met the necessary standards.