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ACRP Certified Professional Sample Questions:

1. Which of the following statements is TRUE about an EDC system?

A) The eCRF should be an exact page-by-page replica of the paper CRF.
B) A separate workstation should be made available for the monitor.
C) There should be an audit trail to track data entries, deletions, and changes.
D) IRB/IEC approval is required before the use of the computerized system.

2. Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A) Sponsor
B) PI
C) CRO
D) Subject

3. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A) Length of time to receive the approved trial device
B) Location of stored trial records
C) Information to be included in the advertising flyer
D) Availability of qualified staff to conduct the trial

4. Centralized monitoring can:

A) Identify IP accountability and storage issues.
B) Indicate the need to send monitors to perform onsite visits.
C) Confirm why sites are deviating from the protocol.
D) Enable appropriate stratification of subject enrollment.

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

Solutions: