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ACRP Certified Professional Sample Questions:

1. The coding system for a double-blind clinical trial is accessible by the:

A) IRB/IEC
B) Regulatory authority
C) Sponsor
D) PI

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

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

3. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) Source document.
B) Worksheet.
C) CRF.
D) PRO.

4. Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A) How effective is the drug at treating patients that have been previously diagnosed with cancer?
B) How willing are current patients to participate in a trial with potentially serious side effects?
C) How likely are patients at high risk of cancer going to develop cancer during the study?
D) How does the risk of developing cancer compare to the anticipated side effects from the drug?

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

Solutions: