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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

A) The CRC is responsible for identifying the relationship of an SAE to the IP.
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 IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
D) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.

2. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A) To establish a procedure for PI oversight of protocol deviations
B) To determine if a protocol amendment is needed
C) To determine if the deviations invalidate the data
D) To escalate corrective actions to the regulatory authority

3. Which strategy is used to safeguard subject privacy?

A) Conduct subject-related conversations in controlled environments.
B) Utilize subject initials on correspondence.
C) Email updated enrollment logs to the CRA.
D) Store source documentation in the CRC's office.

4. A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A) After the protocol amendment is approved by the IRB/IEC
B) As soon as the protocol amendment is submitted to the IRB/IEC
C) When the need for the additional data is discovered
D) After the original planned data collection is completed

5. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Report the AE to the sponsor.
B) Call the medical monitor.
C) Consult the IB.
D) Administer rescue medication.

Solutions: