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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

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

2. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A) Dispose of IP and request replacement from sponsor.
B) Register IP in IWRS and continue with subject allocation.
C) Quarantine IP without registering in IWRS and request replacement from sponsor.
D) Register IP in IWRS, quarantine and notify sponsor of the excursion.

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

4. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

A) Identifying potential study risks.
B) Controlling risk by setting thresholds of risk acceptability.
C) Documenting all possible risk scenarios.
D) Assessing risk based on study impact.

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

Solutions: