Good Clinical Practice (GCP) Practice Exam

What is meant by an audit in the context of clinical trials?

1. A random examination of trial participants’ responses

2. An investigation of a trial's advertising and promotion

3. A systematic examination of trial-related activities

4. An internal review of financial records

The correct answer is: A systematic examination of trial-related activities

An audit in the context of clinical trials refers to a systematic examination of trial-related activities. This process ensures that the trial is being conducted in compliance with regulatory requirements and the study protocol, as well as ethical standards. The purpose of such an audit is to verify that data collection, management, and reporting practices are accurate and consistent with Good Clinical Practice (GCP) guidelines. During a clinical trial audit, various aspects of the trial are reviewed, including the study design, participant recruitment procedures, data handling processes, and adherence to the protocol. This systematic approach not only helps in identifying any discrepancies or areas for improvement but also enhances the overall integrity and credibility of the trial results. The other options do not capture the essence of what an audit entails within clinical trials. For example, a random examination of trial participants’ responses focuses on data collection rather than a comprehensive review of trial activities. Investigating a trial's advertising and promotion is related to regulatory compliance but does not encompass the broad scope of auditing trial conduct. Similarly, an internal review of financial records pertains more to budgeting and funding rather than the systematic assessment of trial processes and adherence to protocols.