CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 1 — 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?
- Protocol
- Investigator Agreement
- Clinical Trial Agreement (Correct answer)
- Delegation of Authority Log
Correct answer: Clinical Trial Agreement
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?
- Enroll the next eligible participant using new criteria
- Submit the amendment to the IRB for approval before implementing (Correct answer)
- Implement the change immediately to protect participants
- Notify the FDA within 24 hours
Correct answer: Submit the amendment to the IRB for approval before implementing
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?
- Provide access only if the participant consents again
- Deny access to protect participant privacy entirely
- Provide access per the consent form and applicable regulations (Correct answer)
- Allow access only with IRB approval for each visit
Correct answer: Provide access per the consent form and applicable regulations
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?
- File it and wait for the next monitoring visit
- Submit the safety information to the IRB promptly (Correct answer)
- Report directly to the FDA on behalf of the sponsor
- Update the protocol without IRB review
Correct answer: Submit the safety information to the IRB promptly
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?
- To request additional study budget
- To document and resolve protocol deviations and prevent recurrence (Correct answer)
- To notify the FDA of site non-compliance
- To terminate the site's participation in the trial
Correct answer: To document and resolve protocol deviations and prevent recurrence
A CAPA plan identifies the root cause of a finding and details specific steps to correct the problem and prevent it from happening again.
Question 6: An FDA investigator arrives unannounced for a study inspection. What is the first step the coordinator should take?
- Ask the investigator to return with a scheduled appointment
- Notify the principal investigator and sponsor immediately (Correct answer)
- Begin shredding outdated study documents
- Delay the inspection until legal counsel is present
Correct answer: Notify the principal investigator and sponsor immediately
The site must welcome the FDA inspector and promptly notify the PI and sponsor so the appropriate personnel and documents are made available.
CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 1
Which document outlines the sponsor's expectations for site conduct and is the primary agreement between a sponsor and a clinical investigator?