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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The number of users with access was not defined.
B) The frequency of data backup was not defined.
C) The list of comparable technology solutions was not included.
D) The number of unique eCRF templates was not specified.

2. A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A) Regulatory authority.
B) IRB/IEC.
C) Sponsor.
D) Medical monitor.

3. After the completion or termination of a clinical trial, who should store the enrollment log?

A) Regulatory authority
B) CRO
C) Sponsor
D) PI

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

5. 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, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
B) A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
C) A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
D) A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population

Solutions: