Only need to practice for 20 to 30 hours

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

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

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

3. A root cause analysis should be:

A) Written by the investigator.
B) Focused on issues of non-compliance.
C) Validated before use in a CAPA.
D) Specific to a clinical trial.

4. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A family member
B) A member of the research team
C) A witness
D) A legally acceptable representative

5. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Clinical Monitoring Plan
B) Standard Operating Procedure
C) Investigator's Brochure
D) Data & Safety Monitoring Plan

Solutions: