CCA CATO Associate Site Initiation & Management

Question 1

What document formally authorizes a clinical site to begin enrolling subjects in a trial?

Accepted Answer

IRB/IEC Approval

Answer

Site Initiation Letter

Answer

Protocol Amendment

Answer

Investigator Brochure

Question 2

During a site initiation visit (SIV), what is the primary purpose of reviewing the delegation log?

Accepted Answer

To confirm staff qualifications and assigned responsibilities

Answer

To verify sponsor payments

Answer

To reconcile investigational product inventory

Answer

To check subject enrollment numbers

Question 3

Which regulatory document must be in place at the site BEFORE any subject can sign the informed consent form?

Accepted Answer

IRB/IEC approval of the consent form

Answer

Final protocol version

Answer

Completed 1572 form

Answer

Signed CTA

Question 4

What is the term for the organized set of essential documents that must be maintained at the investigative site throughout a clinical trial?

Accepted Answer

Investigator Site File (ISF)

Answer

Site Master File

Answer

Clinical Study Report

Answer

Regulatory Binder

Question 5

When a new sub-investigator joins the study team, what is the first required action by the principal investigator?

Accepted Answer

Update the delegation log and submit CV to sponsor

Answer

Notify the sponsor immediately

Answer

Obtain IRB approval for the new staff member

Answer

Amend the clinical trial agreement

Question 6

Which activity is performed during a site qualification visit (SQV)?

Accepted Answer

Evaluating the site's capability and resources to conduct the trial

Answer

Training site staff on the protocol

Answer

Dispensing first units of investigational product

Answer

Reviewing accumulated patient data