ACRP Certified Professional : ACRP-CP Exam

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

A) Submit the diary to the sponsor for approval.
B) No approval is necessary: give the diary to each subject.
C) Submit the diary to the regulatory authority for approval.
D) Submit the diary to the IRB/IEC for approval.

2. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
C) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D) A monitoring report that identifies deviation from the approved protocol.

3. Which of the following is a conflict of interest for a PI conducting a study?

A) A PI who receives payment for the study
B) A PI that presents at an investigator meeting
C) A PI that votes on the IRB/IEC approval of the protocol
D) A PI who is a key opinion leader, writes the protocol

4. Which document confirms the PI's agreement to permit auditing at the study site?

A) Protocol
B) Delegation Log
C) IB
D) ICF

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

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

Solutions: