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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A. Conduct routine investigators' meetings
B. Develop a monitoring plan
C. Draft a CAPA plan
D. Establish a DSMB/IDMC

Question 2

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. Train the research coordinator on the required study assessments schedule.
D. Identify critical processes and data during protocol development.

Question 3

Which statement does NOT represent a study monitor's responsibilities?

A. Report serious adverse events to the IRB/IEC.
B. Verify that the PI has adequate qualifications and resources to conduct the study.
C. Provide communication between the sponsor and the PI.
D. Check the accuracy and completeness of case report forms with source documents.

Question 4

Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

A. CRA
B. CRC
C. Sponsor
D. PI

Question 5

A root cause analysis should be:

A. Written by the investigator.
B. Validated before use in a CAPA.
C. Focused on issues of non-compliance.
D. Specific to a clinical trial.

Solutions: