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ACRP Certified Professional Sample Questions:

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

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

2. After the site qualification visit report has been finalized, it must be:

A) Sent to the IRB/IEC for review and approval.
B) Stored in the sponsor's budgets and contracts file.
C) Kept in the CRO/sponsor's trial master file.
D) Included in the PI's regulatory file.

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

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

4. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A) To determine if the deviations invalidate the data
B) To escalate corrective actions to the regulatory authority
C) To determine if a protocol amendment is needed
D) To establish a procedure for PI oversight of protocol deviations

5. Which of the following should be considered when implementing a risk-based monitoring plan?

A) 100% source document review is mandatory.
B) On-site monitoring frequency may change depending on the quality of the data.
C) Monitoring schedule must be pre-defined in the monitoring plan.
D) Centralized monitoring must be incorporated in any trials.

Solutions: