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ACRP Certified Professional Sample Questions:

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

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

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

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

3. Who ensures information regarding payments to subjects is documented in a written consent form?

A) PI
B) IRB/IEC
C) Coordinator
D) Sponsor

4. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) Clinical Study Protocol
B) Clinical Study Report
C) IDMC/DSMB Report
D) Investigator Brochure

5. An impartial witness should be present during the entire informed consent discussion when:

A) A legally acceptable representative is unable to read.
B) An interpreter is translating the consent form for a subject.
C) A parent/guardian is consenting for a minor subject.
D) A subject has been determined to be vulnerable.

Solutions: