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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. AEs that occur between study visits of a clinical trial should be evaluated by the:

A) Study pharmacovigilance physician
B) Subject's primary care physician
C) Principal Investigator
D) Medical monitor

2. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Data & Safety Monitoring Plan
B) Standard Operating Procedure
C) Clinical Monitoring Plan
D) Investigator's Brochure

3. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The number of users with access was not defined.
B) The frequency of data backup was not defined.
C) The number of unique eCRF templates was not specified.
D) The list of comparable technology solutions was not included.

4. 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) Comparing source document data to other data recorded in the same study time period.
C) Recording the date and time each data element is entered onto the source document.
D) Allowing real-time access for data review in the eCRF.

5. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A) Contemporaneous
B) Attributable
C) Complete
D) Original

Solutions: