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

Why is monitoring source documents critical in clinical trials?

1. To prepare for publication later

2. To ensure quality and accountability of data

3. To simplify audits by sponsors

4. To expedite participant recruitment

The correct answer is: To ensure quality and accountability of data

Monitoring source documents is essential in clinical trials because it ensures the quality and accountability of the data collected throughout the study. Source documents provide primary evidence of what has occurred during the clinical trial, including participant information, consent forms, treatment administration, and any adverse events reported. By closely monitoring these documents, clinical trial personnel can verify that the data reported in the case report forms accurately reflects the original records. This process helps in minimizing errors, ensuring compliance with regulatory requirements, and maintaining the integrity of the trial. Reliable and high-quality data is crucial for the overall credibility of the trial results, which may influence regulatory decisions and clinical practice. Other options, while related to aspects of clinical trials, do not capture the core reason for monitoring source documents. Preparing for publication, simplifying audits, and expediting participant recruitment are important factors in a study but are secondary to the fundamental goal of ensuring data quality and accountability.