Certified Clinical Research Coordinator (CCRC) Practice Exam

If evidence suggests non-compliance at a site, what is the likely action taken by the sponsor?

1. They will ignore it

2. They will conduct a verification

3. They will terminate the trial immediately

4. They will shift the trials to a different site

The correct answer is: They will conduct a verification

In situations where evidence indicates non-compliance at a site, the sponsor's likely action is to conduct a verification. This approach allows the sponsor to assess the extent and nature of the non-compliance before making further decisions. Verification typically involves monitoring activities, reviewing documentation, and possibly conducting on-site visits to gather more information regarding the compliance issues. This step is crucial because it helps ensure that any concerns are based on accurate and comprehensive data, facilitating an informed response to the issues at hand. By choosing to verify compliance rather than immediately terminating the trial or ignoring the issue, sponsors demonstrate due diligence and a commitment to maintaining the integrity of the study. This proactive approach also allows for the possibility of corrective actions to be implemented, which can help bring sites back into compliance while still adhering to regulatory standards and protecting the study's overall validity.