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ACRP Certified Professional Sample Questions:

1. In a quality management system, in which category do risk reduction activities belong?

A) Risk Control
B) Risk Review
C) Risk Evaluation
D) Risk Communication

2. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A) Attributable
B) Contemporaneous
C) Complete
D) Original

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

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

4. 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) A monitoring report that identifies deviation from the approved protocol.
C) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D) Training records of site personnel on study protocol, and their study-related duties and functions.

5. A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A) Phase I
B) Phase IV
C) Phase III
D) Phase II

Solutions: