What does an audit report evaluate?

An audit report primarily evaluates the results of the audit conducted by the sponsor's auditor. This report provides a thorough assessment of various aspects of the clinical trial, such as adherence to protocol, compliance with regulatory requirements, the integrity of data collected, and the overall management of the study. The auditor reviews documentation, case report forms, and other relevant materials to ensure that the trial was conducted in accordance with Good Clinical Practice (GCP) guidelines and the study protocol.

The outcome of this audit not only reflects the current state of the study but also highlights areas for improvement and potential risks, providing valuable insights for both the sponsor and the research site. This evaluation plays a critical role in maintaining the quality of clinical research and ensuring the reliability of the trial results. Such systematic reviews are essential in fostering accountability and transparency within clinical trials.

In contrast, aspects like marketing effectiveness, patient feedback, and potential future trials do not fall within the primary scope of what an audit report evaluates. These elements, while important in their respective domains, do not directly pertain to the audit's focus on compliance, data integrity, and adherence to established protocols.