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ACRP Certified Professional Sample Questions:

1. 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) 3.0 mg/dL
B) 1.8 mg/dL
C) 3.6 mg/dL
D) 2.6 mg/dL


2. The composition of an IDMC/DSMB should include which one of the following?

A) A clinical scientist who is knowledgeable in the appropriate discipline
B) A member from the IRB/IEC
C) A sponsor representative who is knowledgeable about the study's unblinded information
D) A lead PI for the study


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

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


4. The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:

A) Programming
B) Quality Assurance
C) Quality Control
D) Validation


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:

Question # 1
Answer: A
Question # 2
Answer: A
Question # 3
Answer: D
Question # 4
Answer: D
Question # 5
Answer: A

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