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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Perform a periodic review to see if the quality methods are effective and relevant.
B) Determine the quality tolerance limits for data transcription errors.
C) Identify critical processes and data during protocol development.
D) Train the research coordinator on the required study assessments schedule.

2. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A) Sponsor
B) Applicable site SOPs
C) Applicable regulatory authorities
D) PI

3. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A) Obtain IRB/IEC approval
B) Ship/receive IP
C) Verify subject eligibility
D) Schedule a site initiation visit

4. Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

A) Sponsor-Investigator
B) Regulatory authority
C) IRB/IEC
D) CRO

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

A) A monitoring report that identifies deviation from the approved protocol.
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 plan that is tailored to the specific human subject protection and data integrity risks of the trial.

Solutions: