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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A) How does the risk of developing cancer compare to the anticipated side effects from the drug?
B) How willing are current patients to participate in a trial with potentially serious side effects?
C) How effective is the drug at treating patients that have been previously diagnosed with cancer?
D) How likely are patients at high risk of cancer going to develop cancer during the study?

2. An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A) Study sponsor
B) Original reporting investigator
C) Regulatory authority
D) Investigator at each site

3. The sponsor should supply a PI with the IP after:

A) Submission of documents to IRB/IEC and regulatory authority for review.
B) Approval of protocol by the sponsor.
C) Approval of protocol by the PI.
D) Approval/favorable opinion from IRB/IEC and regulatory authority.

4. All of the following are examples of what monitors review EXCEPT:

A) Potential patient medical records for eligibility prior to the informed consent process.
B) Regulatory binder which includes copies of current certifications for all laboratories.
C) The signed ICF retained in the participant's study file.
D) Documentation in the participant's medical record of study drug administration.

5. 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) Monitor
B) Sponsor
C) QA Department
D) Data Manager

Solutions: