Exam ACRP-CP Topic 1 Question 112 Discussion

Actual exam question for ACRP's ACRP-CP exam
Question #: 112
Topic #: 1

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

Suggested Answer: B Vote an answer

Since both the investigator and the participant are unaware of the treatment assignment, the study is classified as double-blind. The study aims to establish the superiority of XYZ over ABC, making it a superiority study.
The use of masked IV bags confirms the double-blind design.
The answer is verified from GCP guidelines on blinding and superiority study designs.
"In double-blind studies, neither the participant nor the investigator knows the treatment assignment, which prevents bias." Objectives:
* Understanding blinding methods in clinical trials
* Ensuring unbiased efficacy comparisons

by Olga at Jul 22, 2026, 11:46 AM

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