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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A) Package insert
B) IB
C) ICF
D) Protocol

2. The sponsor should supply a PI with the IP after:

A) Approval/favorable opinion from IRB/IEC and regulatory authority.
B) Submission of documents to IRB/IEC and regulatory authority for review.
C) Approval of protocol by the sponsor.
D) Approval of protocol by the PI.

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 regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
D) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.

4. When assessing the monitoring needs for a study, sponsors should:

A) Use central monitoring instead of conducting physical monitoring visits at sites.
B) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
C) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
D) Permit PIs to select a monitor for their site as long as they are independent of the PI.

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

Solutions: