Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What is the initial step to take when significant noncompliance is reported at a site?

1. Conduct a Site Visit

2. Notify the Regulatory Authority

3. Implement a Root Cause Analysis

4. Terminate the Site's Participation

The correct answer is: Implement a Root Cause Analysis

Beginning with a root cause analysis is essential when significant noncompliance is reported at a site because it helps identify the underlying reasons that led to the noncompliance rather than just addressing the symptoms. By understanding the root causes, whether they are due to procedural errors, misunderstandings, insufficient training, or other factors, appropriate corrective actions can be effectively developed. This focused approach not only rectifies the current issues but also helps prevent future occurrences of noncompliance. Addressing the other options, conducting a site visit may be useful to gather information, but without first understanding the root of the problem, the visit might not lead to effective solutions. Notifying the regulatory authority is also important, but it typically comes after an assessment of the situation has been conducted. Terminating the site's participation is a severe action and may not be warranted without a clear understanding of the reasons for the noncompliance. Thus, beginning with a root cause analysis ensures a thorough and constructive approach to resolving noncompliance issues.