[2026] ACRP Certified Professional - ACRP-CP 무료 시험 문제

문제1

During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

A. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.

B. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.

C. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.

D. Immediately unblind the entire trial to ensure patient safety.

정답: B

설명: (Fast2test 회원만 볼 수 있음)

문제2

The IB contains which of the following sections?

A. Known pharmacokinetic effects

B. Participant eligibility criteria

C. Participant dosing schedule

D. IP preparation instructions

정답: A

설명: (Fast2test 회원만 볼 수 있음)

문제3

A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

A. A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population

B. A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population

C. A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population

D. A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population

정답: B

설명: (Fast2test 회원만 볼 수 있음)

문제4

Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A. Consult the IB.

B. Report the AE to the sponsor.

C. Call the medical monitor.

D. Administer rescue medication.

정답: D

설명: (Fast2test 회원만 볼 수 있음)

문제5

AEs that occur between study visits of a clinical trial should be evaluated by the:

A. Principal Investigator

B. Subject's primary care physician

C. Study pharmacovigilance physician

D. Medical monitor

정답: A

설명: (Fast2test 회원만 볼 수 있음)

문제6

A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A. Draft a CAPA plan

B. Develop a monitoring plan

C. Establish a DSMB/IDMC

D. Conduct routine investigators' meetings

정답: C

설명: (Fast2test 회원만 볼 수 있음)

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