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ACRP Certified Professional Sample Questions:

1. Which of the following reports should be retained in participant charts?

A) DSMB/IDMC reports
B) Safety reports
C) IRB/IEC progress reports
D) Lab reports

2. An impartial witness should be present during the entire informed consent discussion when:

A) A subject has been determined to be vulnerable.
B) A parent/guardian is consenting for a minor subject.
C) An interpreter is translating the consent form for a subject.
D) A legally acceptable representative is unable to read.

3. Which statement does NOT represent a study monitor's responsibilities?

A) Check the accuracy and completeness of case report forms with source documents.
B) Verify that the PI has adequate qualifications and resources to conduct the study.
C) Provide communication between the sponsor and the PI.
D) Report serious adverse events to the IRB/IEC.

4. When assessing the monitoring needs for a study, sponsors should:

A) Use central monitoring instead of conducting physical monitoring visits at sites.
B) Permit PIs to select a monitor for their site as long as they are independent of the PI.
C) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
D) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.

5. The composition of an IDMC/DSMB should include which one of the following?

A) A sponsor representative who is knowledgeable about the study's unblinded information
B) A member from the IRB/IEC
C) A lead PI for the study
D) A clinical scientist who is knowledgeable in the appropriate discipline

Solutions: