CCA CATO Associate Site Initiation & Management 1 — Questions and Answers
Question 1: What document formally authorizes a clinical site to begin enrolling subjects in a trial?
- Site Initiation Letter
- Protocol Amendment
- Investigator Brochure
- IRB/IEC Approval (Correct answer)
Correct answer: IRB/IEC Approval
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?
- To verify sponsor payments
- To confirm staff qualifications and assigned responsibilities (Correct answer)
- To reconcile investigational product inventory
- To check subject enrollment numbers
Correct 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.
Question 3: Which regulatory document must be in place at the site BEFORE any subject can sign the informed consent form?
- Final protocol version
- IRB/IEC approval of the consent form (Correct answer)
- Completed 1572 form
- Signed CTA
Correct answer: IRB/IEC approval of the consent form
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?
- Site Master File
- Investigator Site File (ISF) (Correct answer)
- Clinical Study Report
- Regulatory Binder
Correct 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.
Question 5: When a new sub-investigator joins the study team, what is the first required action by the principal investigator?
- Notify the sponsor immediately
- Update the delegation log and submit CV to sponsor (Correct answer)
- Obtain IRB approval for the new staff member
- Amend the clinical trial agreement
Correct 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.
Question 6: Which activity is performed during a site qualification visit (SQV)?
- Training site staff on the protocol
- Dispensing first units of investigational product
- Evaluating the site's capability and resources to conduct the trial (Correct answer)
- Reviewing accumulated patient data
Correct 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.
CCA CATO Associate Site Initiation & Management 1
What document formally authorizes a clinical site to begin enrolling subjects in a trial?