ACRP ACRP-CP Questions & Answers - in .pdf
- Total Q&A: 127
- Update: Jun 24, 2026
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- Vendor: ACRP
- Exam Code: ACRP-CP
- Exam Name: ACRP Certified Professional Exam
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ACRP ACRP-CP Q&A - Testing Engine
- Total Q&A: 127
- Update: Jun 24, 2026
- Price: $59.99
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- Exam Code: ACRP-CP
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ACRP Certified Professional Sample Questions:
1. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?
A) Notify the subject.
B) Notify the regulatory authority.
C) Withdraw the subject.
D) Notify the sponsor.
2. During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?
A) Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
B) Immediately unblind the entire trial to ensure patient safety.
C) Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
D) Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
3. Who takes responsibility for initiating a clinical trial?
A) CRO
B) Sponsor
C) IRB/IEC
D) Investigator
4. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:
A) Executive board members.
B) Independent qualified individuals.
C) Investigators participating in the trial.
D) Regulatory authority expert advisors.
5. What would a sponsor use to implement and maintain quality in a study?
A) Statistical analysis plan
B) Clinical trial agreement
C) Protocol signature pages
D) Standard operating procedures
Solutions:
Question # 1
Answer: D | Question # 2
Answer: D | Question # 3
Answer: B | Question # 4
Answer: B | Question # 5
Answer: D |
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