CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 1

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

The Clinical Trial Agreement (CTA) is the binding contract between the sponsor and the site that governs financial, operational, and legal obligations.

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

Protocol amendments that affect participant safety or study conduct must receive IRB approval before implementation at the site.

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

Source document access for monitors is typically authorized in the informed consent form and is required under GCP to verify data integrity.

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

New safety information received from the sponsor must be forwarded to the IRB in a timely manner so the IRB can assess whether consent forms or protocols need updating.

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

A CAPA plan identifies the root cause of a finding and details specific steps to correct the problem and prevent it from happening again.

CCRC - Certified Clinical Research Coordinator Practice Test

CCRC - Certified Clinical Research Coordinator Practice Test

CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 1