ACRP-CP by ACRP Actual Free Exam Questions And Answers

Question 1

Who ensures information regarding payments to subjects is documented in a written consent form?

A. IRB/IEC

B. Coordinator

C. PI

D. Sponsor

Discussion 0

Correct Answer: A Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

Question 2

A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A. CRF.

B. Worksheet.

C. PRO.

D. Source document.

Discussion 0

Correct Answer: A Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

Question 3

While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

A. Get an impartial witness involved in consenting this person.

B. Locate a translator and have them work with the person.

C. There are no circumstances under which this person can be enrolled.

D. Have the Principal Investigator consent the person.

Discussion 0

Correct Answer: A Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

Question 4

A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A. Notify the regulatory authority.

B. Notify the subject.

C. Withdraw the subject.

D. Notify the sponsor.

Discussion 0

Correct Answer: D Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

Question 5

Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

A. The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.

B. The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.

C. The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.

D. The CRC is responsible for identifying the relationship of an SAE to the IP.

Discussion 0

Correct Answer: C Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

Question 6

A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A. A signed clinical trial agreement between the site and sponsor is in place.

B. The CRA has performed source document review and verification at the site.

C. The DSMB meets and the first DSMB meeting report has been issued.

D. The site receives approval from the medical monitor to begin enrolling.

Discussion 0

Correct Answer: A Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

Question 7

Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A. Dispose of IP and request replacement from sponsor.

B. Register IP in IWRS, quarantine and notify sponsor of the excursion.

C. Quarantine IP without registering in IWRS and request replacement from sponsor.

D. Register IP in IWRS and continue with subject allocation.

Discussion 0

Correct Answer: B Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

Question 8

While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

A. Submit revised ICFs to the IRB/IEC with increased compensation for participants.

B. Require participants to provide documented reason for withdrawal.

C. Meet with the site staff to understand their workflows and to review retention strategies.

D. Interview participants who have dropped out.

Discussion 0

Correct Answer: C Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

Question 9

The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A. The CRC should amend the medical chart.

B. The PI should amend the medical chart.

C. The CRC should write a note to file.

D. The PI should notify the monitor.

Discussion 0

Correct Answer: B Vote an answer

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

ACRP Certified Professional - ACRP-CP Exam Practice Test

Contact Us

Useful Links

Latest Updated