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

During a monitoring visit, what records would a CRA reference to verify a subject's compliance with the study visit schedule and assessments?

1. The subject's referral letter

2. The electronic medical record

3. The clinical trial budget

4. The subject's insurance claim forms

The correct answer is: The electronic medical record

The electronic medical record is the most relevant choice for verifying a subject's compliance with the study visit schedule and assessments. These records provide comprehensive documentation of the subject's medical history, including visits, assessments performed, and any other relevant health information tied to the study protocol. By examining the electronic medical record, a Clinical Research Associate (CRA) can confirm whether a subject attended scheduled visits, received the appropriate assessments, and any notes on their condition during the trial. While referral letters, clinical trial budgets, and insurance claim forms contain useful information, they do not directly track or detail a subject's adherence to the study visit schedule or specific assessments performed under the study. Referral letters are typically related to initial consultations and may not include ongoing study information. The clinical trial budget outlines financial aspects but lacks detailed subject visit records. Insurance claim forms may reflect treatments received but do not provide a complete account of participation in the study protocol. Thus, the electronic medical record is the most direct and reliable source for this verification.