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ACRP Certified Professional Sample Questions:

1. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

A) Group sequential
B) Parallel Group
C) Crossover
D) Factorial

2. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
B) Any trial-related duties can be documented as transferred by verbal agreement.
C) The IRB/IEC must approve the transfer of duties to a CRO.
D) All duties transferred to a CRO should be specified in writing.

3. Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

A) 1.8 mg/dL
B) 3.6 mg/dL
C) 2.6 mg/dL
D) 3.0 mg/dL

4. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) PRO.
B) CRF.
C) Worksheet.
D) Source document.

5. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The PI should amend the medical chart.
B) The CRC should write a note to file.
C) The CRC should amend the medical chart.
D) The PI should notify the monitor.

Solutions: