ACRP Certified Professional : ACRP-CP

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question #1
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 who is independent of the institution/trial site.
B. One member of the site's QA group.
C. One member whose primary area of interest is in the same scientific area.
D. A total of five members.

Question #2
A deferred consent can take place in which of the following situations?

A. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
B. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
C. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
D. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.

Question #3
During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A. Conduct safety analysis.
B. Validate protocol endpoints.
C. Evaluate study data.
D. Verify compliance with IP regimen.

Question #4
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A. The frequency of data backup was not defined.
B. The number of users with access was not defined.
C. The list of comparable technology solutions was not included.
D. The number of unique eCRF templates was not specified.

Question #5
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A. Deny the request until the sponsor approves.
B. Allow access to the entire records.
C. Consult with the IRB/IEC first.
D. Redact subject identification for privacy protection.

Solutions: