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ACRP Certified Professional Sample Questions:

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

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

2. While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

A) Interview participants who have dropped out.
B) Submit revised ICFs to the IRB/IEC with increased compensation for participants.
C) Require participants to provide documented reason for withdrawal.
D) Meet with the site staff to understand their workflows and to review retention strategies.

3. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) Clinical Study Protocol
B) IDMC/DSMB Report
C) Clinical Study Report
D) Investigator Brochure

4. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
B) The IRB/IEC must approve the transfer of duties to a CRO.
C) All duties transferred to a CRO should be specified in writing.
D) Any trial-related duties can be documented as transferred by verbal agreement.

5. 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) In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
C) In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
D) Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.

Solutions: