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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. 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) Perform a periodic review to see if the quality methods are effective and relevant.
D) Train the research coordinator on the required study assessments schedule.

2. 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) Placebo-controlled
C) Privacy controls
D) Blinding

3. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Clinical Monitoring Plan
B) Data & Safety Monitoring Plan
C) Standard Operating Procedure
D) Investigator's Brochure

4. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A) Sponsor
B) Investigator
C) IRB/IEC
D) CRO

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

Solutions: