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ACRP Certified Professional Sample Questions:

1. The PI should ensure that source data is:

A) Accurately reflected in the eCRFs.
B) Printed directly from the EMR.
C) Kept on site for a minimum of 2 years.
D) On worksheets that are provided by the sponsor.

2. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A) CRO
B) Investigator
C) IRB/IEC
D) Sponsor

3. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Privacy controls
B) Blinding
C) Randomization
D) Placebo-controlled

4. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A) Allow access to the entire records.
B) Deny the request until the sponsor approves.
C) Consult with the IRB/IEC first.
D) Redact subject identification for privacy protection.

5. A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

A) Sponsor.
B) Regulatory authority.
C) IRB/IEC.
D) Medical monitor.

Solutions: