Certified Clinical Research Coordinator (CCRC) Practice Exam

If a subject has consistently elevated WBC count with no clinical signs, what should the investigator do?

1. Report the elevated WBCs to the sponsor as an unexpected adverse event

2. Ignore the elevated WBC counts

3. Request a follow-up evaluation by a specialist

4. Wait for the next study visit to reassess

The correct answer is: Report the elevated WBCs to the sponsor as an unexpected adverse event

When a subject exhibits consistently elevated white blood cell (WBC) counts without any clinical signs, the investigator is required to report this finding to the sponsor as an unexpected adverse event. This is because an elevated WBC count can indicate an underlying issue, such as an infection or inflammatory response, even if the subject does not show any outward clinical signs. Reporting such results is crucial for several reasons. Firstly, it ensures that the sponsor is aware of potential safety concerns associated with the study and the investigational product being tested. It contributes to the ongoing assessment of the drug’s safety profile. Secondly, documenting unexpected adverse events is important for regulatory compliance, allowing for the collection of comprehensive data that might be relevant to other participants in the study or future studies. Transparency in documenting any deviations from normal laboratory results is vital for protecting the well-being of subjects and upholding the integrity of the research protocol. In this instance, ignoring the elevated WBC counts could lead to missed opportunities for identifying safety issues, while waiting for the next study visit to reassess may delay necessary intervention or monitoring. Consulting a specialist could be an appropriate action but does not replace the obligation to report these findings to the sponsor. Thus, reporting the elevation ensures that all necessary parties are