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

2. Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

A) Investigator
B) CRO
C) Sponsor
D) CRC

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

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

4. The IB contains which of the following sections?

A) Known pharmacokinetic effects
B) Participant eligibility criteria
C) IP preparation instructions
D) Participant dosing schedule

5. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Placebo-controlled
B) Blinding
C) Privacy controls
D) Randomization

Solutions: