Good Clinical Practice (GCP) Practice Exam

At what intervals does the Independent Data-Monitoring Committee typically assess a clinical trial?

1. Weekly

2. Once at the end of the trial

3. At regular intervals throughout the trial

4. Only after major safety concerns arise

The correct answer is: At regular intervals throughout the trial

The Independent Data-Monitoring Committee (IDMC) is responsible for overseeing the data and safety of participants enrolled in a clinical trial. They conduct their assessments at regular intervals throughout the trial to ensure ongoing safety and efficacy. By reviewing accumulated data periodically, the IDMC can identify any emerging safety issues, assess the efficacy of the intervention, and determine whether the trial should continue, be modified, or be terminated. This proactive approach is essential in maintaining participant safety and the integrity of the clinical trial, allowing for timely decisions based on the data that has been collected up to that point. Regular assessments ensure that any potential risks are addressed promptly and ethically, which is a fundamental safety principle in clinical research.