ACRP CCRA EXAM AND PRACTICE EXAM NEWEST
2026/ 2027 TEST BANK| ARCP CCRA CERTIFICATION
EXAM PREP WITH COMPLETE 550 REAL EXAM
QUESTIONS AND CORRECT VERIFIED ANSWERS/
ALREADY GRADED A+ (BRAND NEW!!)
Q1. Which document serves as the international ethical and
scientific quality standard for designing, conducting,
recording, and reporting clinical trials involving human
subjects?
A) Declaration of Helsinki
B) Belmont Report
C) ICH GCP E6(R2) / E6(R3)
D) 21 CFR Part 11
Answer: C
Rationale: ICH GCP E6 is the international standard for clinical
trials. The Declaration of Helsinki (A) provides ethical principles
1
,but not a comprehensive quality standard; the Belmont Report (B)
outlines three ethical principles; 21 CFR Part 11 (D) governs
electronic records .
Q2. Under ICH GCP, the responsibility for initiating,
managing, and financing a clinical trial lies with the:
A) Clinical Research Associate (CRA)
B) Investigator
C) Sponsor
D) Institutional Review Board (IRB)
Answer: C
Rationale: The Sponsor is responsible for initiating, managing,
and financing the clinical trial. The Investigator (B) conducts the
trial at the site; the CRA (A) monitors the trial; the IRB (D) protects
subject rights .
2
,Q3. The Belmont Report established three basic ethical
principles for research involving human subjects. Which of the
following is NOT one of these principles?
A) Respect for persons
B) Beneficence
C) Justice
D) Confidentiality
Answer: D
Rationale: The Belmont Report's three principles are Respect for
Persons, Beneficence, and Justice. Confidentiality is an important
derived requirement but not one of the three foundational
principles .
Q4. According to ICH GCP, which of the following is one of
the core principles regarding trial subjects?
A) Informed consent is not required for low-risk studies
3
, B) The rights, safety, and well-being of trial subjects are the most
important considerations
C) Data can be fabricated as long as results are consistent
D) Investigators do not need to be qualified
Answer: B
Rationale: ICH GCP principle #1 states that the rights, safety,
and well-being of trial subjects are the most important
considerations and must prevail over interests of science and
society .
Q5. The Declaration of Helsinki is primarily concerned with:
A) Good Manufacturing Practices (GMP)
B) Ethical principles for medical research involving human subjects
C) Financial disclosure requirements
D) Data privacy regulations
4
2026/ 2027 TEST BANK| ARCP CCRA CERTIFICATION
EXAM PREP WITH COMPLETE 550 REAL EXAM
QUESTIONS AND CORRECT VERIFIED ANSWERS/
ALREADY GRADED A+ (BRAND NEW!!)
Q1. Which document serves as the international ethical and
scientific quality standard for designing, conducting,
recording, and reporting clinical trials involving human
subjects?
A) Declaration of Helsinki
B) Belmont Report
C) ICH GCP E6(R2) / E6(R3)
D) 21 CFR Part 11
Answer: C
Rationale: ICH GCP E6 is the international standard for clinical
trials. The Declaration of Helsinki (A) provides ethical principles
1
,but not a comprehensive quality standard; the Belmont Report (B)
outlines three ethical principles; 21 CFR Part 11 (D) governs
electronic records .
Q2. Under ICH GCP, the responsibility for initiating,
managing, and financing a clinical trial lies with the:
A) Clinical Research Associate (CRA)
B) Investigator
C) Sponsor
D) Institutional Review Board (IRB)
Answer: C
Rationale: The Sponsor is responsible for initiating, managing,
and financing the clinical trial. The Investigator (B) conducts the
trial at the site; the CRA (A) monitors the trial; the IRB (D) protects
subject rights .
2
,Q3. The Belmont Report established three basic ethical
principles for research involving human subjects. Which of the
following is NOT one of these principles?
A) Respect for persons
B) Beneficence
C) Justice
D) Confidentiality
Answer: D
Rationale: The Belmont Report's three principles are Respect for
Persons, Beneficence, and Justice. Confidentiality is an important
derived requirement but not one of the three foundational
principles .
Q4. According to ICH GCP, which of the following is one of
the core principles regarding trial subjects?
A) Informed consent is not required for low-risk studies
3
, B) The rights, safety, and well-being of trial subjects are the most
important considerations
C) Data can be fabricated as long as results are consistent
D) Investigators do not need to be qualified
Answer: B
Rationale: ICH GCP principle #1 states that the rights, safety,
and well-being of trial subjects are the most important
considerations and must prevail over interests of science and
society .
Q5. The Declaration of Helsinki is primarily concerned with:
A) Good Manufacturing Practices (GMP)
B) Ethical principles for medical research involving human subjects
C) Financial disclosure requirements
D) Data privacy regulations
4
