CCA CATO Associate Site Initiation & Management 2 — Questions and Answers
Question 1: What is the purpose of a protocol training session conducted at site initiation?
- To obtain IRB approval
- To ensure all site staff understand the study procedures and their responsibilities (Correct answer)
- To randomize the first patient
- To finalize the budget
Correct answer: To ensure all site staff understand the study procedures and their responsibilities
Protocol training at SIV ensures that all site personnel understand the study requirements, procedures, and their specific roles.
Question 2: Which of the following is a key component verified during the site initiation visit regarding laboratory facilities?
- Central lab courier schedule
- Local lab certification and normal reference ranges (Correct answer)
- IRB meeting minutes
- Data entry credentials
Correct answer: Local lab certification and normal reference ranges
During SIV, the CRA verifies local laboratory certification and confirms that current normal reference ranges are on file.
Question 3: If a site has not enrolled any subjects within 6 months of initiation, what action should the monitor consider recommending?
- Increase investigational product supply
- Request a protocol amendment
- Consider site non-performance review or closure (Correct answer)
- Re-train all site staff
Correct answer: Consider site non-performance review or closure
A site that fails to enroll patients within a reasonable period after initiation may be considered for a non-performance review or deactivation.
Question 4: What document captures the agreement between the sponsor and the investigative site regarding financial compensation and obligations?
- Delegation of Authority Log
- Clinical Trial Agreement (CTA) (Correct answer)
- Investigator Brochure
- Site Initiation Report
Correct answer: Clinical Trial Agreement (CTA)
The Clinical Trial Agreement (CTA) is a contract between the sponsor and site that outlines financial terms, obligations, and responsibilities.
Question 5: Who is ultimately responsible for the conduct of a clinical trial at an investigative site?
- The Clinical Research Associate (CRA)
- The Institutional Review Board (IRB)
- The Principal Investigator (PI) (Correct answer)
- The Sponsor's Medical Monitor
Correct answer: The Principal Investigator (PI)
The Principal Investigator is ultimately responsible for the conduct of the clinical trial at their site per GCP guidelines.
Question 6: What is the purpose of the 'essential documents' checklist used at site initiation?
- To track patient recruitment numbers
- To confirm all required regulatory and administrative documents are in place before enrollment begins (Correct answer)
- To schedule monitoring visits
- To reconcile drug inventory
Correct answer: To confirm all required regulatory and administrative documents are in place before enrollment begins
The essential documents checklist ensures all required documents are collected and filed before the site can enroll subjects.
CCA CATO Associate Site Initiation & Management 2
What is the purpose of a protocol training session conducted at site initiation?