Good Clinical Practice (GCP) Practice Exam

What is the purpose of an audit report?

1. A detailed summary of the clinical outcomes

2. A written evaluation by the sponsor's auditor of the results of the audit

3. A tool for increasing participant engagement

4. A record of the trial's development history

The correct answer is: A written evaluation by the sponsor's auditor of the results of the audit

The purpose of an audit report is primarily to provide a written evaluation by the sponsor's auditor regarding the results of an audit conducted during a clinical trial. This document serves as a crucial part of the clinical research process, offering insights into compliance with regulatory standards, study protocols, and overall trial integrity. The audit report summarizes findings from the audit, addressing areas such as adherence to Good Clinical Practice (GCP) guidelines, data integrity, and any identified discrepancies or issues that need to be rectified. This report is essential for sponsors and regulatory bodies as it informs them about the strengths and weaknesses of the trial processes and can influence future actions, including the approval of trial results or iterations of study protocols. The other options reference elements that might be relevant in the context of clinical trials but do not capture the specific evaluative purpose that the audit report serves. While clinical outcomes are important, an audit report focuses more on compliance and assessment rather than merely summarizing results. Engaging participants is also an important aspect of trials but is not a function of the audit report. Similarly, documenting the trial's development history falls outside the purpose of an audit report, which concentrates on current compliance and quality assurance aspects rather than historical records.