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ACRP Certified Professional Sample Questions:

1. Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

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

2. Who determines the age of assent for pediatric studies?

A) Sponsor
B) PI
C) IRB/IEC
D) Parent

3. Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

A) Ensure submission of a data management plan to the regulatory authorities.
B) Develop a plan that describes the monitoring approach for a clinical study.
C) Conduct annual reviews of the protocol and accompanying study documents.
D) Ensure there is an accompanying written record that describes the consent process.

4. A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
B) Before accepting this site, report the risk to the trial sponsor and await their decision.
C) Accept this site and plan to undertake routine safety evaluations of the IP.
D) Accept this site and implement and maintain QA and QC systems with written SOPs.

5. In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

A) One member whose primary area of interest is in the same scientific area.
B) A total of five members.
C) One member who is independent of the institution/trial site.
D) One member of the site's QA group.

Solutions: