Certified Clinical Research Coordinator (CCRC) Practice Exam

What is the overall goal of monitoring, audits, and inspection activities in clinical research?

1. To maintain financial accountability

2. To ensure the protection of human research subjects and data integrity

3. To increase the number of clinical trials

4. To minimize the duration of trial phases

The correct answer is: To ensure the protection of human research subjects and data integrity

The overall goal of monitoring, audits, and inspection activities in clinical research is to ensure the protection of human research subjects and data integrity. These activities are essential for safeguarding the rights, safety, and well-being of participants involved in clinical trials. By conducting thorough monitoring, audits, and inspections, researchers and regulatory bodies can verify that the trial is being conducted in compliance with ethical standards and regulatory requirements. This process helps confirm that informed consent is properly obtained, that adverse events are reported and managed appropriately, and that the study data is accurate, reliable, and verifiable. Protecting human subjects is a fundamental principle in clinical research, ensuring that their participation is ethical and that their rights are respected throughout the study. Additionally, ensuring data integrity is critical for producing valid and trustworthy results, which can impact decisions regarding future clinical practices and regulatory approvals. Thus, the emphasis on monitoring and oversight activities significantly contributes to upholding ethical standards and scientific rigor in clinical trials.