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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Ethical and Participant Safety Considerations | - Regulatory compliance
|
| Topic 2: Quality Management | - Risk management
|
| Topic 3: Clinical Trial Operations | - Study start-up activities
|
| Topic 4: Data Management and Documentation | - Clinical trial documentation
|
| Topic 5: Professional Responsibilities | - Communication and collaboration
|
ACRP Certified Professional Sample Questions:
A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?
- A. Evaluate the screen failures to determine if the protocol needs revision.
- B. Re-train investigators on recruitment obligations.
- C. Allocate additional monitoring resources to the trial.
- D. Reduce the target sample size based on feedback from the sites.
Correct Answer: A 🗳️
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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.
Correct Answer: A 🗳️
Explanation: Only visible for DumpsTorrent members. You can sign-up / login (it's free).
All site financial matters pertaining to a trial are listed in what document?
- A. Financial disclosure
- B. Informed consent form
- C. Protocol
- D. Signed contract
Correct Answer: D 🗳️
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The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?
- A. Time to occurrence of symptoms of the disease
- B. Use of concomitant medications to treat the symptoms
- C. Occurrence of known side effects of the IP
- D. Impact of an approved vaccine against the disease
Correct Answer: A 🗳️
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A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:
- A. Worksheet.
- B. PRO.
- C. Source document.
- D. CRF.
Correct Answer: D 🗳️
Explanation: Only visible for DumpsTorrent members. You can sign-up / login (it's free).
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