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ACRP Certified Professional Sample Questions:

1. 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) Availability of qualified staff to conduct the trial
D) Information to be included in the advertising flyer

2. The IB contains which of the following sections?

A) Known pharmacokinetic effects
B) IP preparation instructions
C) Participant eligibility criteria
D) Participant dosing schedule

3. During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A) Evaluate study data.
B) Verify compliance with IP regimen.
C) Conduct safety analysis.
D) Validate protocol endpoints.

4. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Identify critical processes and data during protocol development.
B) Determine the quality tolerance limits for data transcription errors.
C) Train the research coordinator on the required study assessments schedule.
D) Perform a periodic review to see if the quality methods are effective and relevant.

5. Who is responsible for the ongoing safety evaluation of the IP?

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

Solutions: