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ACRP Certified Professional Sample Questions:

1. IP is dispensed to all subjects who:

A) Consented for the trial.
B) Are eligible to receive it in the trial.
C) Need IP for their medical condition.
D) Screened for the trial.

2. 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) Blinding
B) Privacy controls
C) Randomization
D) Placebo-controlled

3. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Identify critical processes and data during protocol development.
B) Determine the quality tolerance limits for data transcription errors.
C) Train the research coordinator on the required study assessments schedule.
D) Perform a periodic review to see if the quality methods are effective and relevant.

4. Who is responsible for the ongoing safety evaluation of the IP?

A) IRB/IEC
B) Sponsor
C) PI
D) Regulatory agency

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

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

Solutions: