ACRP Certified Professional : ACRP-CP

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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, open-label, comparator 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, single-blind, placebo-controlled 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

2. Centralized monitoring can:

A) Enable appropriate stratification of subject enrollment.
B) Confirm why sites are deviating from the protocol.
C) Identify IP accountability and storage issues.
D) Indicate the need to send monitors to perform onsite visits.

3. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) Investigator
B) Health authority
C) Sponsor
D) DSMB/IDMC

4. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) QA Department
B) Sponsor
C) Monitor
D) Data Manager

5. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) PI
B) Regulatory Agency
C) CRC
D) Sponsor

Solutions: