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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A. Data Manager
B. Monitor
C. QA Department
D. Sponsor

Question 2

The inclusion and exclusion criteria are in place so all subjects are:

A. Ethically vulnerable and patients with the disease under study.
B. Medically appropriate and protected from ethical vulnerability.
C. Healthy and willing to complete the clinical trial.
D. Patients with the disease under study and will not have any adverse events.

Question 3

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. Documenting all possible risk scenarios.
C. Controlling risk by setting thresholds of risk acceptability.
D. Assessing risk based on study impact.

Question 4

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

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

Question 5

Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A. CRO
B. PI
C. Subject
D. Sponsor

Solutions: