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ACRP Certified Professional Sample Questions:

1. 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) Randomization
B) Privacy controls
C) Blinding
D) Placebo-controlled

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

A) Recording the date and time each data element is entered onto the source document.
B) Recording data on source documents at the time the data are collected during the conduct of the study.
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.

3. After the site qualification visit report has been finalized, it must be:

A) Kept in the CRO/sponsor's trial master file.
B) Sent to the IRB/IEC for review and approval.
C) Included in the PI's regulatory file.
D) Stored in the sponsor's budgets and contracts file.

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) Programming
B) Quality Control
C) Quality Assurance
D) Validation

5. Who must be blinded in a double-blind study in order to prevent bias?

A) Pharmacist
B) Subject
C) IRB/IEC
D) Data entry staff

Solutions: