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

IRB/IEC approval is the formal authorization that permits a site to begin enrolling subjects into a clinical trial.

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

The delegation log is reviewed at SIV to confirm that all site staff are properly qualified and have been assigned appropriate trial responsibilities.

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

IRB/IEC approval of the informed consent form must be obtained before any subject is consented.

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

The Investigator Site File (ISF) contains the essential documents required at the site to demonstrate compliance with GCP and regulatory requirements.

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

The PI must update the delegation log with the sub-investigator's roles and submit their CV and training records to the sponsor.

(CCA) CATO Certified Associate Practice Test

(CCA) CATO Certified Associate Practice Test

CCA CATO Associate Site Initiation & Management