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ACRP Certified Professional Sample Questions:

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

2. A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

A) The site should retain the essential documents longer to meet the regulatory requirements.
B) The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
C) The site may proceed with the destruction of the essential documents.
D) The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.

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

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

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

5. What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

A) Audit
B) Site qualification
C) Routine monitoring
D) Inspection

Solutions: