Certified Clinical Research Coordinator (CCRC) Practice Exam

What is the first step a CRC should take when a subject becomes non-compliant?

1. Document the incident

2. Notify the IRB immediately

3. Consult with the investigator

4. Discontinue the subject

The correct answer is: Consult with the investigator

When a subject becomes non-compliant in a clinical trial, the first step a Clinical Research Coordinator (CRC) should take is to consult with the investigator. This step is crucial because the investigator has the ultimate responsibility for the safety and wellbeing of the subjects as well as for ensuring the integrity of the study data. By consulting with the investigator, the CRC can gain a clearer understanding of the situation and determine appropriate actions that may include addressing compliance issues directly with the subject, considering any necessary modifications to the study protocol, or deciding whether further action is warranted. This step emphasizes the importance of communication and collaboration within the research team. The investigator may have insights into why the subject is non-compliant and may also have strategies in place for addressing such situations. Effective resolution often requires a tailored approach based on the specific circumstances surrounding the subject's non-compliance. Taking this initial action ensures that any response is consistent with regulatory guidelines and the study protocol, protecting both the subject and the research project as a whole.