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ACRP ACRP-CP Exam Syllabus Topics:

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

2. Who is responsible for submitting a protocol amendment to the IRB/IEC?

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

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

A) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
B) The CRC is responsible for identifying the relationship of an SAE to the IP.
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.

4. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A witness
B) A legally acceptable representative
C) A member of the research team
D) A family member

5. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring report that identifies deviation from the approved protocol.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
C) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

Solutions: