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

Which document should detail the findings from monitoring a closed clinical trial?

1. The Final Report

2. The Close-out Report

3. The Monitoring Report

4. The Study Protocol

The correct answer is: The Close-out Report

The document that should detail the findings from monitoring a closed clinical trial is the Close-out Report. This report is specifically designed to summarize the overall outcomes of the trial, including insights drawn from monitoring activities. It includes information about the trial's conduct, any deviations from the protocol, data management practices, and final outcome measures. The Close-out Report serves as a comprehensive account that reflects the status of the investigation at the time of closing. It provides essential information that researchers and stakeholders can review to understand how the study was managed and any relevant observations that emerged during monitoring. This is particularly important for ensuring transparency and accountability in clinical research, as it allows for evaluation of the study's integrity and compliance with regulatory expectations. In contrast, while the other documents may play various roles in the clinical trial process, they do not specifically encapsulate the monitoring findings of a closed trial. The Final Report typically summarizes the overall results and conclusions of the study rather than the monitoring aspects. The Monitoring Report generally outlines ongoing monitoring activities and findings during the study, so it would not reflect the overall insights after closure. Meanwhile, the Study Protocol lays out the plan for the study prior to initiation, including objectives, design, and methodology, but does not encompass the findings from the monitoring conducted