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

What should the sponsor do if serious noncompliance is identified from an investigator?

1. Offer additional training to the investigator

2. Promptly notify the regulatory authorities and terminate participation

3. Conduct a further site monitoring visit

4. Ignore the findings unless complaints arise

The correct answer is: Promptly notify the regulatory authorities and terminate participation

When serious noncompliance is identified from an investigator, the appropriate course of action is to promptly notify the regulatory authorities and terminate participation. This approach is crucial because serious noncompliance can jeopardize the integrity of the study, affect participant safety, and potentially lead to adverse outcomes in the research. Reporting to regulatory authorities ensures that the issue is formally documented and addressed, maintaining accountability and upholding ethical standards in research practices. Terminating the participation of the investigator prevents any further compromise of the study and protects the interests of both the participants and the integrity of the collected data. This action reflects a commitment to compliance with regulatory guidelines and emphasizes the importance of adherence to protocols in clinical research. Other options may not adequately address the seriousness of the noncompliance. For example, offering additional training may not be sufficient if the violation is severe. Conducting a further site monitoring visit may help assess the situation, but it does not directly resolve the issue of noncompliance. Ignoring the findings is not a viable option as it undermines the ethical and regulatory framework governing clinical research. Thus, the most responsible and effective approach is to notify the regulatory authorities and terminate the investigator's participation.