CCA CATO Associate Site Initiation & Management 2

Question 1

What is the purpose of a protocol training session conducted at site initiation?

Accepted Answer

To ensure all site staff understand the study procedures and their responsibilities

Answer

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?

Accepted Answer

Local lab certification and normal reference ranges

Answer

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?

Accepted Answer

Consider site non-performance review or closure

Answer

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?

Accepted Answer

Clinical Trial Agreement (CTA)

Answer

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?

Accepted Answer

The Principal Investigator (PI)

Answer

The Principal Investigator is ultimately responsible for the conduct of the clinical trial at their site per GCP guidelines.

(CCA) CATO Certified Associate Practice Test