CRA ACRP ACTUAL EXAM TEST PAPER FULL QUESTIONS CORRECT RESPONSES
Question:
What takes priority in clinical research?
Answer:
The rights, safety, and well-being of subjects.
Question:
What is the ethical foundation document for human subject research?
Answer:
Declaration of Helsinki.
Question:
What are the three core ethical principles?
Answer:
Respect for persons; Beneficence; Justice.
Question:
What does respect for persons mean?
Answer:
Autonomy and informed consent.
Question:
What does beneficence mean?
Answer:
, Maximize benefits and minimize harm.
Question:
What does justice mean?
Answer:
Fair and equitable subject selection.
Question:
What guideline governs GCP?
Answer:
ICH E6.
Question:
Which version of ICH E6 is referenced for 2025 exams?
Answer:
E6 (R2) with principles aligned to E6 (R3).
Question:
What is the primary focus of ICH E6 (R3)?
Answer:
Quality by design, risk-based approach, subject protection.
Question:
Does the ACRP exam test FDA regulations?
Answer:
No, the exam is based on ICH and global GCP principles.
Question:
What takes priority in clinical research?
Answer:
The rights, safety, and well-being of subjects.
Question:
What is the ethical foundation document for human subject research?
Answer:
Declaration of Helsinki.
Question:
What are the three core ethical principles?
Answer:
Respect for persons; Beneficence; Justice.
Question:
What does respect for persons mean?
Answer:
Autonomy and informed consent.
Question:
What does beneficence mean?
Answer:
, Maximize benefits and minimize harm.
Question:
What does justice mean?
Answer:
Fair and equitable subject selection.
Question:
What guideline governs GCP?
Answer:
ICH E6.
Question:
Which version of ICH E6 is referenced for 2025 exams?
Answer:
E6 (R2) with principles aligned to E6 (R3).
Question:
What is the primary focus of ICH E6 (R3)?
Answer:
Quality by design, risk-based approach, subject protection.
Question:
Does the ACRP exam test FDA regulations?
Answer:
No, the exam is based on ICH and global GCP principles.