Good Clinical Practice (GCP) Practice Exam

What characterizes a trial-related audit?

1. Focus solely on financial aspects

2. Independently examining activities and documents

3. Examining only patient surveys

4. Evaluating only the final results of the study

The correct answer is: Independently examining activities and documents

A trial-related audit is characterized by the independent examination of activities and documents associated with a clinical trial. This process ensures that the trial is conducted according to the protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements. By evaluating various aspects of the study, such as participant recruitment, data collection, and adherence to study protocols, the audit helps to ensure data integrity and the safety of participants. This independent examination is crucial because it enables auditors to verify whether all procedures have been followed correctly and whether the documentation matches the activities performed. This thorough scrutiny not only reinforces compliance but also enhances the credibility and reliability of the study's findings. Focusing solely on financial aspects, examining only patient surveys, or evaluating only the final results of the study does not embody the holistic approach that a trial-related audit requires. The objective of an audit is to take a comprehensive look at all aspects of the clinical trial to ensure correct practices were maintained throughout the study.