ACRP ACRP-CP

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

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

2. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?

A) To escalate corrective actions to the regulatory authority
B) To establish a procedure for PI oversight of protocol deviations
C) To determine if a protocol amendment is needed
D) To determine if the deviations invalidate the data

3. One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

A) Recording data on source documents at the time the data are collected during the conduct of the study.
B) Allowing real-time access for data review in the eCRF.
C) Comparing source document data to other data recorded in the same study time period.
D) Recording the date and time each data element is entered onto the source document.

4. Centralized monitoring can:

A) Indicate the need to send monitors to perform onsite visits.
B) Confirm why sites are deviating from the protocol.
C) Identify IP accountability and storage issues.
D) Enable appropriate stratification of subject enrollment.

5. Which of the following elements of the Informed Consent are NOT required?

A) Statement that study involves research
B) Subject legal rights can be waived
C) A description of any reasonably foreseeable risks or discomforts
D) A description of potential benefits

Solutions: