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

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

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

3. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) QA Department
B) Monitor
C) Data Manager
D) Sponsor

4. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Investigator's Brochure
B) Standard Operating Procedure
C) Clinical Monitoring Plan
D) Data & Safety Monitoring Plan

5. Which of the following statements is TRUE about an EDC system?

A) The eCRF should be an exact page-by-page replica of the paper CRF.
B) A separate workstation should be made available for the monitor.
C) There should be an audit trail to track data entries, deletions, and changes.
D) IRB/IEC approval is required before the use of the computerized system.

Solutions: