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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Who should vote during the IRB/IEC review and discussion process?

A) All IRB/IEC members
B) All IRB/IEC members and non-member experts
C) All members who were involved in the review and discussion and non-member experts
D) All members who were involved in the review and discussion

2. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A) Dispose of IP and request replacement from sponsor.
B) Quarantine IP without registering in IWRS and request replacement from sponsor.
C) Register IP in IWRS and continue with subject allocation.
D) Register IP in IWRS, quarantine and notify sponsor of the excursion.

3. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?

A) Time to occurrence of symptoms of the disease
B) Impact of an approved vaccine against the disease
C) Use of concomitant medications to treat the symptoms
D) Occurrence of known side effects of the IP

4. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, informed consent, and clinical trial agreement
B) Protocol, site coordinator CVs, and clinical trial agreement
C) Protocol, IB, and information about payments and compensation available to subjects
D) IB, site coordinator CVs, and information about payments and compensation available to subjects

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

Solutions: