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ACRP Certified Professional Sample Questions:

1. Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A) How effective is the drug at treating patients that have been previously diagnosed with cancer?
B) How willing are current patients to participate in a trial with potentially serious side effects?
C) How likely are patients at high risk of cancer going to develop cancer during the study?
D) How does the risk of developing cancer compare to the anticipated side effects from the drug?

2. Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

A) CRC
B) Sponsor
C) PI
D) CRA

3. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B) A monitoring report that identifies deviation from the approved protocol.
C) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D) Training records of site personnel on study protocol, and their study-related duties and functions.

4. When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

A) PD affected participant recruitment.
B) Sponsor approved the PD.
C) Participant verbally agreed to the PD.
D) PD affected participant safety.

5. 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.

Solutions: