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

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

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

3. A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

A) Reduce the target sample size based on feedback from the sites.
B) Evaluate the screen failures to determine if the protocol needs revision.
C) Allocate additional monitoring resources to the trial.
D) Re-train investigators on recruitment obligations.

4. When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

A) Sponsor approved the PD.
B) Participant verbally agreed to the PD.
C) PD affected participant safety.
D) PD affected participant recruitment.

5. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B) A monitoring report that identifies deviation from the approved protocol.
C) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
D) Training records of site personnel on study protocol, and their study-related duties and functions.

Solutions: