CATO Associate Site Initiation & Management Flashcards

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

Answer: IRB/IEC Approval

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

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

Answer: To confirm staff qualifications and assigned responsibilities

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

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

Answer: IRB/IEC approval of the consent form

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

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

Answer: Investigator Site File (ISF)

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

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

Answer: Update the delegation log and submit CV to sponsor

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

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

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

The SQV assesses whether a site has the necessary facilities, staff, and patient population to conduct the trial before selection.