CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers

Question 1

Which document outlines the sponsor's expectations for site conduct and is the primary agreement between a sponsor and a clinical investigator?

Accepted Answer

Clinical Trial Agreement

Answer

Protocol

Answer

Investigator Agreement

Answer

Delegation of Authority Log

Question 2

When a sponsor sends a protocol amendment that changes inclusion/exclusion criteria, what must the site coordinator do FIRST?

Accepted Answer

Submit the amendment to the IRB for approval before implementing

Answer

Enroll the next eligible participant using new criteria

Answer

Implement the change immediately to protect participants

Answer

Notify the FDA within 24 hours

Question 3

During a sponsor monitoring visit, the Clinical Research Associate (CRA) requests access to source documents. What is the coordinator's obligation?

Accepted Answer

Provide access per the consent form and applicable regulations

Answer

Provide access only if the participant consents again

Answer

Deny access to protect participant privacy entirely

Answer

Allow access only with IRB approval for each visit

Question 4

A sponsor issues a Safety Letter describing a new serious risk identified in another study. What is the coordinator's required action?

Accepted Answer

Submit the safety information to the IRB promptly

Answer

File it and wait for the next monitoring visit

Answer

Report directly to the FDA on behalf of the sponsor

Answer

Update the protocol without IRB review

Question 5

What is the purpose of a Corrective and Preventive Action (CAPA) plan submitted to a sponsor after a monitoring finding?

Accepted Answer

To document and resolve protocol deviations and prevent recurrence

Answer

To request additional study budget

Answer

To notify the FDA of site non-compliance

Answer

To terminate the site's participation in the trial

Question 6

An FDA investigator arrives unannounced for a study inspection. What is the first step the coordinator should take?

Accepted Answer

Notify the principal investigator and sponsor immediately

Answer

Ask the investigator to return with a scheduled appointment

Answer

Begin shredding outdated study documents

Answer

Delay the inspection until legal counsel is present