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ACRP Certified Professional Sample Questions:

1. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Randomization
B) Privacy controls
C) Blinding
D) Placebo-controlled

2. SAEs must be reported immediately by the site to the:

A) Regulatory agency.
B) IRB/IEC.
C) DSMB/IDMC.
D) Sponsor.

3. A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

A) Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
B) Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
C) Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
D) Report this incident immediately to the sponsor and leave the treatment decision to them.

4. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) DSMB/IDMC
B) Investigator
C) Sponsor
D) Health authority

5. When assessing the monitoring needs for a study, sponsors should:

A) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
B) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
C) Use central monitoring instead of conducting physical monitoring visits at sites.
D) Permit PIs to select a monitor for their site as long as they are independent of the PI.

Solutions: