CATO Associate Site Initiation & Management Flashcards

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

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.

Which of the following is a key component verified during the site initiation visit regarding laboratory facilities?

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.

If a site has not enrolled any subjects within 6 months of initiation, what action should the monitor consider recommending?

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.

What document captures the agreement between the sponsor and the investigative site regarding financial compensation and obligations?

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.

Who is ultimately responsible for the conduct of a clinical trial at an investigative site?

Answer: The Principal Investigator (PI)

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

What is the purpose of the 'essential documents' checklist used at site initiation?

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.