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ACRP Certified Professional Sample Questions:

1. 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) Quality Assurance
C) Programming
D) Quality Control

2. The sponsor should supply a PI with the IP after:

A) Approval/favorable opinion from IRB/IEC and regulatory authority.
B) Approval of protocol by the PI.
C) Submission of documents to IRB/IEC and regulatory authority for review.
D) Approval of protocol by the sponsor.

3. A study protocol must contain which of the following elements?

A) Description of statistical methods
B) Chemical structure of the IP
C) Participant reimbursement details
D) Data management plan

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

5. At a close-out visit, which document should be retained only at the site?

A) Treatment allocation
B) IP accountability
C) Subject identification code list
D) Final trial close-out monitoring report

Solutions: