CRA Site Initiation & Monitoring Visits 3

Question 1

Which regulatory document must be in place before the first subject can be enrolled at a US clinical trial site?

Accepted Answer

Signed FDA Form 1572

Answer

FDA Form 1572 is the Statement of Investigator, which must be signed before the investigator can conduct an IND-regulated study in the US.

Question 2

A CRA is reviewing the delegation of authority log during a monitoring visit. What is the most critical thing to verify?

Accepted Answer

That each person's delegated tasks fall within their professional qualifications and training

Answer

Tasks must only be delegated to individuals whose qualifications and training allow them to perform those duties safely and in compliance with regulations.

Question 3

During a close-out visit, which action regarding the Investigational Product (IP) must be completed before the visit is considered finished?

Accepted Answer

Completing final drug accountability reconciliation and arranging destruction or return of all IP

Answer

Final drug accountability must reconcile all dispensed, returned, and remaining IP, and all unused product must be returned to the sponsor or destroyed per protocol.

Question 4

What does the term 'essential documents' refer to in clinical research monitoring?

Accepted Answer

Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced

Answer

ICH E6(R2) defines essential documents as those that permit evaluation of trial conduct and data quality, and they must be retained in both the ISF and the Trial Master File.

Question 5

A site has missed the required follow-up visit window for three subjects. As the CRA, you should:

Accepted Answer

Document the protocol deviations and ensure the site submits reports to the IRB and sponsor per the protocol requirements

Answer

Missed visit windows are protocol deviations that require documentation, reporting to the IRB and sponsor as specified in the protocol, and corrective action planning.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA Site Initiation & Monitoring Visits 3