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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) IDMC/DSMB Report
B) Investigator Brochure
C) Clinical Study Report
D) Clinical Study Protocol

2. At a close-out visit, which document should be retained only at the site?

A) Subject identification code list
B) Treatment allocation
C) Final trial close-out monitoring report
D) IP accountability

3. A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

A) Alternate dose
B) No treatment
C) Active control
D) Placebo

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

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

5. An impartial witness should be present during the entire informed consent discussion when:

A) A parent/guardian is consenting for a minor subject.
B) A subject has been determined to be vulnerable.
C) An interpreter is translating the consent form for a subject.
D) A legally acceptable representative is unable to read.

Solutions: