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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) Worksheet.
B) Source document.
C) CRF.
D) PRO.

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

A) Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
B) Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
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.

3. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

A) Assessing risk based on study impact.
B) Documenting all possible risk scenarios.
C) Identifying potential study risks.
D) Controlling risk by setting thresholds of risk acceptability.

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

5. Centralized monitoring can:

A) Identify IP accountability and storage issues.
B) Enable appropriate stratification of subject enrollment.
C) Indicate the need to send monitors to perform onsite visits.
D) Confirm why sites are deviating from the protocol.

Solutions: