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

During a monitoring visit, what records would a CRA review to confirm a subject's compliance with study schedules?

1. Subject diaries

2. Paper charts

3. Electronic medical record

4. Monitoring visit reports

The correct answer is: Electronic medical record

The electronic medical record is a critical resource in confirming a subject's compliance with study schedules. These records typically contain comprehensive and up-to-date information about a patient's medical history, treatment, and any scheduled visits or interventions they have undergone. The ability to efficiently access and analyze this data allows the Clinical Research Associate (CRA) to verify if the subject adhered to the timelines set forth in the study protocol. In this context, while subject diaries, paper charts, and monitoring visit reports may contain relevant information about individual subjects, they might not be as consistently accurate or comprehensive as electronic medical records. Subject diaries depend on the participant's personal entries, which could be subjective or inconsistently maintained. Paper charts, although valuable, can be incomplete due to potential issues with legibility or missing documentation. Monitoring visit reports are summaries of previous site visits rather than real-time data about the subject’s adherence to the study schedule. Therefore, the electronic medical record stands out as the most reliable option for validating compliance with established study timelines.