Good Clinical Practice (GCP) Practice Exam

What is the main objective of monitoring in a clinical trial?

1. To ensure compliance with approval timelines

2. To assess the financial health of the trial

3. To supervise the trial’s adherence to protocols and regulations

4. To evaluate patient satisfaction

The correct answer is: To supervise the trial’s adherence to protocols and regulations

The primary purpose of monitoring in a clinical trial is to supervise the trial's adherence to established protocols and regulatory requirements. This includes ensuring that the study follows good clinical practice guidelines, which are set to protect the rights, safety, and wellbeing of participants. Monitoring activities involve reviewing the processes for data collection, verifying the accuracy of the information reported, and ensuring that the trial is conducted according to its approved protocols. Effectively monitoring helps identify issues early on, which can prevent deviations from the protocol and minimize potential risks to participants, ultimately leading to the integrity of the trial results. While compliance with approval timelines, the financial health of the trial, and patient satisfaction are important considerations in a clinical trial, they do not directly reflect the fundamental objectives of monitoring. Monitoring primarily focuses on protocol adherence and regulatory compliance, which are essential for the overall success and ethical conduct of clinical research.