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ACRP Certified Professional Sample Questions:

1. 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 lead PI for the study
C) A clinical scientist who is knowledgeable in the appropriate discipline
D) A member from the IRB/IEC

2. 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.

3. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A) Sponsor
B) Applicable regulatory authorities
C) Applicable site SOPs
D) PI

4. Who must be blinded in a double-blind study in order to prevent bias?

A) Subject
B) Pharmacist
C) IRB/IEC
D) Data entry staff

5. The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:

A) Validation
B) Programming
C) Quality Control
D) Quality Assurance

Solutions: