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

To obtain IRB approval

Answer

To randomize the first patient

Answer

To finalize the budget

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

Central lab courier schedule

Answer

IRB meeting minutes

Answer

Data entry credentials

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

Increase investigational product supply

Answer

Request a protocol amendment

Answer

Re-train all site staff

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

Delegation of Authority Log

Answer

Investigator Brochure

Answer

Site Initiation Report

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 Clinical Research Associate (CRA)

Answer

The Institutional Review Board (IRB)

Answer

The Sponsor's Medical Monitor

Question 6

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

Accepted Answer

To confirm all required regulatory and administrative documents are in place before enrollment begins

Answer

To track patient recruitment numbers

Answer

To schedule monitoring visits

Answer

To reconcile drug inventory