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

When a compliant subject forgets to bring her medication to a visit, what should the investigator do?

1. Immediately report her noncompliance

2. Document the incident and request her to return the medication

3. Conduct a Root Cause Analysis

4. Provide additional medication for the visit

The correct answer is: Document the incident and request her to return the medication

Documenting the incident and requesting the subject to return the medication is the appropriate course of action because it ensures that the situation is accurately recorded for future reference while simultaneously addressing the immediate need for medication. This documentation serves several purposes: it creates a reliable record of medication compliance issues that could impact the study results, helps to maintain a comprehensive data trail for regulatory oversight, and may assist in evaluating the subject's adherence pattern over time. Requesting the subject to return the medication also reflects consideration for their well-being and reinforces the importance of adhering to the prescribed regimen. This approach fosters open communication between the investigator and the subject, which is crucial for ensuring trusts and compliance with the study protocol. The focus is placed not solely on compliance but also on the subject's health and the integrity of the research. Other options would not adequately address the situation. Reporting immediate noncompliance may not factor in the context of forgetting, and conducting a root cause analysis is excessive at this early stage. Providing additional medication could lead to complications regarding dosage records and compliance assessments, which can impact the study's data integrity.