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ACRP Certified Professional Sample Questions:

1. During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A) Validate protocol endpoints.
B) Evaluate study data.
C) Verify compliance with IP regimen.
D) Conduct safety analysis.

2. What would a sponsor use to implement and maintain quality in a study?

A) Protocol signature pages
B) Statistical analysis plan
C) Standard operating procedures
D) Clinical trial agreement

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) Re-train investigators on recruitment obligations.
C) Evaluate the screen failures to determine if the protocol needs revision.
D) Allocate additional monitoring resources to the trial.

4. The coding system for a double-blind clinical trial is accessible by the:

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

5. In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A) PI
B) IRB/IEC
C) CRC
D) CRA

Solutions: