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ACRP Certified Professional Sample Questions:

1. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A) Quarantine IP without registering in IWRS and request replacement from sponsor.
B) Register IP in IWRS and continue with subject allocation.
C) Register IP in IWRS, quarantine and notify sponsor of the excursion.
D) Dispose of IP and request replacement from sponsor.

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

3. 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, even when this process is not described in the protocol, but the sponsor approves the consent process.
D) In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.

4. Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

A) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
B) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
C) The CRC is responsible for identifying the relationship of an SAE to the IP.
D) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.

5. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

A) CRO
B) Data Manager
C) CRA
D) Sponsor

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