CCRC
CCRC – CERTIFIED CLINICAL RESEARCH COORDINATOR | EXAM
QUESTIONS AND CORRECT ANSWERS | VERIFIED CLINICAL
RESEARCH CERTIFICATION
CERTIFIED CLINICAL RESEARCH COORDINATOR (CCRC)
1. Which principle did the Nuremberg Code establish as its first and
most essential requirement for human experimentation?
A. The voluntary consent of the human subject is absolutely essential
B. All study results must be published within one year
C. Placebo-controlled studies are prohibited in all circumstances
D. Every study must be reviewed by an institutional review board
ANSWER : A. The voluntary consent of the human subject is
absolutely essential
The Nuremberg Code (1947) placed voluntary consent as its first and
most fundamental principle.
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, CCRC
2. The Belmont Report identifies three basic ethical principles for
research involving human subjects. Which set is correct?
A. Respect for persons, beneficence, and justice
B. Justice, privacy, and voluntariness
C. Autonomy, confidentiality, and equity
D. Beneficence, nonmaleficence, and fidelity
ANSWER : A. Respect for persons, beneficence, and justice
The Belmont Report (1979) is built on respect for persons, beneficence,
and justice.
3. Under the Belmont Report, the informed consent process is the
practical application of which principle?
A. Fidelity
B. Justice
C. Beneficence
D. Respect for persons
ANSWER : D. Respect for persons
Respect for persons recognizes individual autonomy, which is honored
through informed consent.
4. A site enrolls subjects only from a free clinic because they are easy to
recruit, even though the condition affects all income groups. Which
Belmont principle is most at risk?
A. Respect for persons
B. Veracity
C. Justice
D. Beneficence
ANSWER : C. Justice
Justice requires the fair selection of subjects so that burdens are not
placed on one group for convenience.
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, CCRC
5. The systematic assessment of risks and benefits during protocol
review is the application of which Belmont principle?
A. Respect for persons
B. Autonomy
C. Beneficence
D. Justice
ANSWER : C. Beneficence
Beneficence obliges researchers to maximize possible benefits and
minimize possible harms.
6. The Declaration of Helsinki was developed and adopted by which
organization?
A. International Council for Harmonisation
B. World Medical Association
C. U.S. Food and Drug Administration
D. World Health Organization
ANSWER : B. World Medical Association
The World Medical Association first adopted the Declaration of Helsinki in
1964 and revises it periodically.
7. Public reaction to the U.S. Public Health Service syphilis study at
Tuskegee most directly led to which development?
A. The National Research Act of 1974 and the commission that wrote the
Belmont Report
B. The Nuremberg Code
C. The Kefauver-Harris Amendments
D. 21 CFR Part 11
ANSWER : A. The National Research Act of 1974 and the commission
that wrote the Belmont Report
The National Research Act created the National Commission, which
produced the Belmont Report.
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, CCRC
8. The thalidomide tragedy contributed to the passage of which
legislation?
A. The 1962 Kefauver-Harris Amendments requiring proof of
effectiveness and informed consent
B. The Health Insurance Portability and Accountability Act
C. The 1938 Federal Food, Drug, and Cosmetic Act
D. The FDA Amendments Act of 2007
ANSWER : A. The 1962 Kefauver-Harris Amendments requiring
proof of effectiveness and informed consent
The Kefauver-Harris Amendments required substantial evidence of
efficacy and consent from investigational drug subjects.
9. Which event prompted passage of the 1938 Federal Food, Drug, and
Cosmetic Act requiring proof of safety before marketing?
A. The Tuskegee syphilis study
B. The Willowbrook hepatitis studies
C. Deaths from Elixir Sulfanilamide prepared with diethylene glycol
D. Birth defects caused by thalidomide
ANSWER : C. Deaths from Elixir Sulfanilamide prepared with
diethylene glycol
More than 100 deaths from Elixir Sulfanilamide led Congress to require
premarket safety evidence.
10. The Willowbrook State School studies are most often cited as
unethical because researchers:
A. Exposed soldiers to radiation without their knowledge
B. Deliberately infected institutionalized children with hepatitis, with
admission linked to enrollment
C. Injected live cancer cells into elderly patients without consent
D. Withheld penicillin from men with syphilis
ANSWER : B. Deliberately infected institutionalized children with
hepatitis, with admission linked to enrollment
Children with intellectual disabilities were infected with hepatitis, and
parents faced pressure because enrollment affected admission.
Page 4 of 64
CCRC – CERTIFIED CLINICAL RESEARCH COORDINATOR | EXAM
QUESTIONS AND CORRECT ANSWERS | VERIFIED CLINICAL
RESEARCH CERTIFICATION
CERTIFIED CLINICAL RESEARCH COORDINATOR (CCRC)
1. Which principle did the Nuremberg Code establish as its first and
most essential requirement for human experimentation?
A. The voluntary consent of the human subject is absolutely essential
B. All study results must be published within one year
C. Placebo-controlled studies are prohibited in all circumstances
D. Every study must be reviewed by an institutional review board
ANSWER : A. The voluntary consent of the human subject is
absolutely essential
The Nuremberg Code (1947) placed voluntary consent as its first and
most fundamental principle.
Page 1 of 64
, CCRC
2. The Belmont Report identifies three basic ethical principles for
research involving human subjects. Which set is correct?
A. Respect for persons, beneficence, and justice
B. Justice, privacy, and voluntariness
C. Autonomy, confidentiality, and equity
D. Beneficence, nonmaleficence, and fidelity
ANSWER : A. Respect for persons, beneficence, and justice
The Belmont Report (1979) is built on respect for persons, beneficence,
and justice.
3. Under the Belmont Report, the informed consent process is the
practical application of which principle?
A. Fidelity
B. Justice
C. Beneficence
D. Respect for persons
ANSWER : D. Respect for persons
Respect for persons recognizes individual autonomy, which is honored
through informed consent.
4. A site enrolls subjects only from a free clinic because they are easy to
recruit, even though the condition affects all income groups. Which
Belmont principle is most at risk?
A. Respect for persons
B. Veracity
C. Justice
D. Beneficence
ANSWER : C. Justice
Justice requires the fair selection of subjects so that burdens are not
placed on one group for convenience.
Page 2 of 64
, CCRC
5. The systematic assessment of risks and benefits during protocol
review is the application of which Belmont principle?
A. Respect for persons
B. Autonomy
C. Beneficence
D. Justice
ANSWER : C. Beneficence
Beneficence obliges researchers to maximize possible benefits and
minimize possible harms.
6. The Declaration of Helsinki was developed and adopted by which
organization?
A. International Council for Harmonisation
B. World Medical Association
C. U.S. Food and Drug Administration
D. World Health Organization
ANSWER : B. World Medical Association
The World Medical Association first adopted the Declaration of Helsinki in
1964 and revises it periodically.
7. Public reaction to the U.S. Public Health Service syphilis study at
Tuskegee most directly led to which development?
A. The National Research Act of 1974 and the commission that wrote the
Belmont Report
B. The Nuremberg Code
C. The Kefauver-Harris Amendments
D. 21 CFR Part 11
ANSWER : A. The National Research Act of 1974 and the commission
that wrote the Belmont Report
The National Research Act created the National Commission, which
produced the Belmont Report.
Page 3 of 64
, CCRC
8. The thalidomide tragedy contributed to the passage of which
legislation?
A. The 1962 Kefauver-Harris Amendments requiring proof of
effectiveness and informed consent
B. The Health Insurance Portability and Accountability Act
C. The 1938 Federal Food, Drug, and Cosmetic Act
D. The FDA Amendments Act of 2007
ANSWER : A. The 1962 Kefauver-Harris Amendments requiring
proof of effectiveness and informed consent
The Kefauver-Harris Amendments required substantial evidence of
efficacy and consent from investigational drug subjects.
9. Which event prompted passage of the 1938 Federal Food, Drug, and
Cosmetic Act requiring proof of safety before marketing?
A. The Tuskegee syphilis study
B. The Willowbrook hepatitis studies
C. Deaths from Elixir Sulfanilamide prepared with diethylene glycol
D. Birth defects caused by thalidomide
ANSWER : C. Deaths from Elixir Sulfanilamide prepared with
diethylene glycol
More than 100 deaths from Elixir Sulfanilamide led Congress to require
premarket safety evidence.
10. The Willowbrook State School studies are most often cited as
unethical because researchers:
A. Exposed soldiers to radiation without their knowledge
B. Deliberately infected institutionalized children with hepatitis, with
admission linked to enrollment
C. Injected live cancer cells into elderly patients without consent
D. Withheld penicillin from men with syphilis
ANSWER : B. Deliberately infected institutionalized children with
hepatitis, with admission linked to enrollment
Children with intellectual disabilities were infected with hepatitis, and
parents faced pressure because enrollment affected admission.
Page 4 of 64
