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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. 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) Redact subject identification for privacy protection.
C) Consult with the IRB/IEC first.
D) Deny the request until the sponsor approves.

2. When designing a clinical trial, why is it important to define the study population?

A) To determine the study objectives
B) To support subject recruitment to the study
C) To support the study objectives
D) To determine where to conduct the study

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) Placebo-controlled
C) Randomization
D) Blinding

4. 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 Control
C) Programming
D) Quality Assurance

5. Which of the following reports should be retained in participant charts?

A) IRB/IEC progress reports
B) Lab reports
C) DSMB/IDMC reports
D) Safety reports

Solutions: