ACRP Certified Professional : ACRP-CP exam

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They can attend the meeting and can vote/provide opinion on whether to approve the study.
B) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
C) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
D) They cannot be the PI on the clinical study due to conflict of interest.

2. A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

A) Re-train investigators on recruitment obligations.
B) Reduce the target sample size based on feedback from the sites.
C) Allocate additional monitoring resources to the trial.
D) Evaluate the screen failures to determine if the protocol needs revision.

3. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A) Sponsor
B) IRB/IEC
C) Investigator
D) CRO

4. Which one of the following is a primary objective of a Phase III study of a new IP?

A) To show superiority over another treatment
B) To establish the safety profile
C) To establish dose information
D) To demonstrate or confirm therapeutic benefit

5. A root cause analysis should be:

A) Written by the investigator.
B) Focused on issues of non-compliance.
C) Validated before use in a CAPA.
D) Specific to a clinical trial.

Solutions: