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ACRP Certified Professional Sample Questions:

1. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A) Co-monitoring of CRO site visits
B) Pre-qualification assessment of CRO
C) Risk-based audits of CRO activities as delegated
D) Central monitoring of data fields by sponsor

2. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A) Develop a monitoring plan
B) Conduct routine investigators' meetings
C) Draft a CAPA plan
D) Establish a DSMB/IDMC

3. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A) To determine if the deviations invalidate the data
B) To escalate corrective actions to the regulatory authority
C) To determine if a protocol amendment is needed
D) To establish a procedure for PI oversight of protocol deviations

4. After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

A) Submit the diary to the regulatory authority for approval.
B) Submit the diary to the sponsor for approval.
C) No approval is necessary: give the diary to each subject.
D) Submit the diary to the IRB/IEC for approval.

5. 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) 2.6 mg/dL
B) 3.0 mg/dL
C) 3.6 mg/dL
D) 1.8 mg/dL

Solutions: