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ACRP Certified Professional Sample Questions:

1. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) IDMC/DSMB Report
B) Clinical Study Protocol
C) Investigator Brochure
D) Clinical Study Report

2. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A) No, the PI is taking part in too many ongoing studies to participate in this study.
B) Yes, the PI can perform other imaging scans instead of the PET scans.
C) Yes, the PI has a sufficient patient population to take part in this study.
D) No, the PI does not have the resources to perform all protocol-required procedures.

3. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A) Investigator
B) Sponsor
C) IRB/IEC
D) CRO

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

5. Who determines the age of assent for pediatric studies?

A) Sponsor
B) PI
C) IRB/IEC
D) Parent

Solutions: