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ACRP Certified Professional Sample Questions:

1. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A) Conduct routine investigators' meetings
B) Draft a CAPA plan
C) Develop a monitoring plan
D) Establish a DSMB/IDMC

2. Source data/documentation should be:

A) Attributable, legible, contemporaneous, original, accurate, and clear.
B) Attributable, legible, correct, original, accurate, and complete.
C) Attributable, legible, contemporaneous, original, accurate, and complete.
D) Attributable, legible, correct, original, accurate, and clear.

3. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They cannot be the PI on the clinical study due to conflict of interest.
B) They can attend the meeting and can vote/provide opinion on whether to approve the study.
C) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
D) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.

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

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

Solutions: