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ACRP Certified Professional Sample Questions:

1. A serious unexpected ADR is one:

A) That does not need to be reported to the IRB/IEC.
B) Severity and nature of the reaction is consistent with protocol.
C) Where the severity of the reaction is not consistent with IB.
D) That results in the death of the subject.

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

3. Who is responsible for the ongoing safety evaluation of the IP?

A) PI
B) IRB/IEC
C) Regulatory agency
D) Sponsor

4. Source data/documentation should be:

A) Attributable, legible, contemporaneous, original, accurate, and clear.
B) Attributable, legible, correct, original, accurate, and complete.
C) Attributable, legible, contemporaneous, original, accurate, and complete.
D) Attributable, legible, correct, original, accurate, and clear.

5. Which of the following elements of the Informed Consent are NOT required?

A) A description of any reasonably foreseeable risks or discomforts
B) Statement that study involves research
C) A description of potential benefits
D) Subject legal rights can be waived

Solutions: