CRA Site Initiation & Monitoring Visits 2

Question 1

During a Site Initiation Visit (SIV), which document confirms the site has received and reviewed the final approved protocol?

Accepted Answer

Protocol signature page signed by the PI

Answer

The protocol signature page signed by the Principal Investigator documents that the PI has reviewed and accepted responsibility for conducting the study per the approved protocol.

Question 2

A CRA discovers during a monitoring visit that a sub-investigator was added to the study team but was not submitted to the IRB. What is the correct immediate action?

Accepted Answer

Advise the site to submit an amendment to the IRB before the sub-investigator sees any subjects

Answer

Any new personnel conducting study procedures must be approved by the IRB before participating; the site must submit an amendment and receive approval prior to that individual's involvement.

Question 3

What is the primary purpose of source data verification (SDV) during a monitoring visit?

Accepted Answer

To confirm that data in the CRF accurately reflects original source records

Answer

SDV ensures data integrity by comparing case report form entries directly against original source documents such as medical records and lab reports.

Question 4

During a routine monitoring visit, a CRA finds that informed consent was obtained AFTER the subject completed the screening visit procedures. This constitutes:

Accepted Answer

A serious protocol deviation that must be reported to the IRB and sponsor

Answer

Obtaining informed consent after study procedures begin is a serious deviation because it violates the subject's right to consent prior to participation and must be reported.

Question 5

At a Site Initiation Visit, which item in the Investigator Site File (ISF) should the CRA confirm is current and site-specific?

Accepted Answer

Laboratory normal reference ranges for the site's local lab

Answer

Laboratory normal reference ranges must reflect the specific lab used by the site and must be current, as they are used to evaluate subject safety data.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA Site Initiation & Monitoring Visits 2