Good Clinical Practice (GCP) Practice Exam

What is the main function of Quality Assurance (QA) in clinical trials?

1. To monitor trial costs

2. To ensure compliance with GCP and regulatory requirements

3. To improve patient satisfaction ratings

4. To develop marketing strategies

The correct answer is: To ensure compliance with GCP and regulatory requirements

The main function of Quality Assurance (QA) in clinical trials is to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements. This is vital for maintaining the integrity of the trial data and safeguarding the rights, safety, and well-being of trial participants. QA is focused on establishing systems, processes, and methodologies that promote adherence to regulatory standards throughout the trial lifecycle, from planning and execution to reporting and archiving data. By implementing QA measures, organizations can systematically assess and enhance the processes involved in conducting clinical trials, thus preventing deviations from established protocols and ensuring that any non-compliance issues are identified and addressed promptly. This rigor ultimately contributes to the quality and reliability of the clinical trial results, which are essential for the approval and market entry of new medical interventions. In contrast, the other options are not primary functions of QA in clinical trials. Monitoring trial costs, improving patient satisfaction ratings, and developing marketing strategies are important aspects in the broader context of clinical research, but they do not focus on the core QA responsibilities which concentrate on compliance with GCP standards and regulatory guidelines.