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ACRP Certified Professional Sample Questions:

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

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

2. After the completion or termination of a clinical trial, who should store the enrollment log?

A) CRO
B) Sponsor
C) Regulatory authority
D) PI

3. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
B) The IRB/IEC must approve the transfer of duties to a CRO.
C) Any trial-related duties can be documented as transferred by verbal agreement.
D) All duties transferred to a CRO should be specified in writing.

4. Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

A) IRB/IEC
B) Sponsor-Investigator
C) CRO
D) Regulatory authority

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

Solutions: