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ACRP Certified Professional Sample Questions:

1. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A) Report a protocol deviation to the IRB/IEC.
B) Notify the sponsor.
C) Call the participant to return for an unscheduled visit.
D) Notify the PI.

2. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A) Information to be included in the advertising flyer
B) Availability of qualified staff to conduct the trial
C) Location of stored trial records
D) Length of time to receive the approved trial device

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

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

4. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A) 77%
B) 66%
C) 71%
D) 80%

5. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
B) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
C) They cannot be the PI on the clinical study due to conflict of interest.
D) They can attend the meeting and can vote/provide opinion on whether to approve the study.

Solutions: