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ACRP Certified Professional Sample Questions:

1. The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A) Inform participant and assure proper care is provided.
B) Inform the monitor of the termination of the study.
C) Inform the IRB/IEC of the study closure.
D) Schedule participant for early termination visit.

2. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A) 8 calendar days
B) 15 calendar days
C) 7 calendar days
D) 30 calendar days

3. 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.

4. A deferred consent can take place in which of the following situations?

A) Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
B) Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
C) In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
D) In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.

5. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A) Applicable regulatory authorities
B) Applicable site SOPs
C) PI
D) Sponsor

Solutions: