SOCRA CCRP® Exam Practice
Questions (Verified 2022/2023)100+
Questions with Correct Answers and
Detailed Rationales
SECTION 1: REGULATORY FRAMEWORKS AND DEFINITIONS
(Questions 1-20)
Question 1
What does 21 CFR Part 11 address?
A) Protection of human subjects
B) Electronic records and electronic signatures
C) Investigational new drug applications
D) Institutional Review Boards
Correct Answer: B) Electronic records and electronic signatures
Rationale: 21 CFR Part 11 establishes FDA regulations for electronic
records and electronic signatures, setting standards for their use in
FDA-regulated industries. This includes requirements for ensuring that
electronic records are trustworthy, reliable, and equivalent to paper
records. Part 50 addresses human subject protection, Part 312 covers
IND applications, and Part 56 governs IRBs.
,Question 2
The Belmont Report established which three basic ethical principles?
A) Autonomy, non-maleficence, and justice
B) Respect for persons, beneficence, and justice
C) Informed consent, risk assessment, and confidentiality
D) Privacy, confidentiality, and respect
Correct Answer: B) Respect for persons, beneficence, and justice
Rationale: The Belmont Report (1979) established three fundamental
ethical principles for research involving human subjects: Respect for
Persons (recognizing autonomy and protecting those with diminished
autonomy), Beneficence (maximizing benefits while minimizing
harms), and Justice (fair distribution of research burdens and
benefits). These principles form the foundation for federal regulations
protecting human subjects.
Question 3
Which regulation covers Investigational New Drug (IND) applications?
A) 21 CFR Part 50
B) 21 CFR Part 56
C) 21 CFR Part 312
D) 21 CFR Part 812
Correct Answer: C) 21 CFR Part 312
Rationale: 21 CFR Part 312 establishes requirements for
Investigational New Drug (IND) applications. It covers the submission
process, content requirements, protocol amendments, safety
,reporting, and the conditions under which an IND is required. Part 50
covers informed consent, Part 56 covers IRBs, and Part 812 covers
Investigational Device Exemptions (IDE).
Question 4
What is the definition of a "Sponsor" under 21 CFR Part 50?
A) An individual who conducts a clinical investigation
B) A person who initiates a clinical investigation but does not actually
conduct it
C) A review board that approves research
D) A participant in a clinical trial
Correct Answer: B) A person who initiates a clinical investigation but
does not actually conduct it
Rationale: Under 21 CFR Part 50.3, a sponsor is a person who initiates
a clinical investigation but does not actually conduct it. The test article
is administered or dispensed to subjects under the immediate
direction of another individual (the investigator). A corporation or
agency that uses employees to conduct a study it initiated is
considered a sponsor, and the employees are investigators.
Question 5
What is the definition of "Minimal Risk" under federal regulations?
A) No risk of harm to participants
B) Probability and magnitude of harm no greater than those ordinarily
encountered in daily life or during routine physical or psychological
examinations
, C) Risk that is acceptable only if participants are compensated
D) Risk that requires full IRB review
Correct Answer: B) Probability and magnitude of harm no greater than
those ordinarily encountered in daily life or during routine physical or
psychological examinations
Rationale: Minimal risk is defined as the probability and magnitude of
harm or discomfort anticipated in research that are not greater than
those ordinarily encountered in daily life or during routine physical or
psychological examinations or tests. This definition appears in both
21 CFR Part 50.3 and 45 CFR Part 46.102.
Question 6
The Nuremberg Code was established in:
A) 1947
B) 1964
C) 1979
D) 1996
Correct Answer: A) 1947
Rationale: The Nuremberg Code was established in 1947 following the
Nuremberg Trials of Nazi physicians. It set forth ten principles for
ethical human experimentation, with voluntary informed consent being
the first and most fundamental principle. The Declaration of Helsinki
was established in 1964, and the Belmont Report was published in
1979.
Questions (Verified 2022/2023)100+
Questions with Correct Answers and
Detailed Rationales
SECTION 1: REGULATORY FRAMEWORKS AND DEFINITIONS
(Questions 1-20)
Question 1
What does 21 CFR Part 11 address?
A) Protection of human subjects
B) Electronic records and electronic signatures
C) Investigational new drug applications
D) Institutional Review Boards
Correct Answer: B) Electronic records and electronic signatures
Rationale: 21 CFR Part 11 establishes FDA regulations for electronic
records and electronic signatures, setting standards for their use in
FDA-regulated industries. This includes requirements for ensuring that
electronic records are trustworthy, reliable, and equivalent to paper
records. Part 50 addresses human subject protection, Part 312 covers
IND applications, and Part 56 governs IRBs.
,Question 2
The Belmont Report established which three basic ethical principles?
A) Autonomy, non-maleficence, and justice
B) Respect for persons, beneficence, and justice
C) Informed consent, risk assessment, and confidentiality
D) Privacy, confidentiality, and respect
Correct Answer: B) Respect for persons, beneficence, and justice
Rationale: The Belmont Report (1979) established three fundamental
ethical principles for research involving human subjects: Respect for
Persons (recognizing autonomy and protecting those with diminished
autonomy), Beneficence (maximizing benefits while minimizing
harms), and Justice (fair distribution of research burdens and
benefits). These principles form the foundation for federal regulations
protecting human subjects.
Question 3
Which regulation covers Investigational New Drug (IND) applications?
A) 21 CFR Part 50
B) 21 CFR Part 56
C) 21 CFR Part 312
D) 21 CFR Part 812
Correct Answer: C) 21 CFR Part 312
Rationale: 21 CFR Part 312 establishes requirements for
Investigational New Drug (IND) applications. It covers the submission
process, content requirements, protocol amendments, safety
,reporting, and the conditions under which an IND is required. Part 50
covers informed consent, Part 56 covers IRBs, and Part 812 covers
Investigational Device Exemptions (IDE).
Question 4
What is the definition of a "Sponsor" under 21 CFR Part 50?
A) An individual who conducts a clinical investigation
B) A person who initiates a clinical investigation but does not actually
conduct it
C) A review board that approves research
D) A participant in a clinical trial
Correct Answer: B) A person who initiates a clinical investigation but
does not actually conduct it
Rationale: Under 21 CFR Part 50.3, a sponsor is a person who initiates
a clinical investigation but does not actually conduct it. The test article
is administered or dispensed to subjects under the immediate
direction of another individual (the investigator). A corporation or
agency that uses employees to conduct a study it initiated is
considered a sponsor, and the employees are investigators.
Question 5
What is the definition of "Minimal Risk" under federal regulations?
A) No risk of harm to participants
B) Probability and magnitude of harm no greater than those ordinarily
encountered in daily life or during routine physical or psychological
examinations
, C) Risk that is acceptable only if participants are compensated
D) Risk that requires full IRB review
Correct Answer: B) Probability and magnitude of harm no greater than
those ordinarily encountered in daily life or during routine physical or
psychological examinations
Rationale: Minimal risk is defined as the probability and magnitude of
harm or discomfort anticipated in research that are not greater than
those ordinarily encountered in daily life or during routine physical or
psychological examinations or tests. This definition appears in both
21 CFR Part 50.3 and 45 CFR Part 46.102.
Question 6
The Nuremberg Code was established in:
A) 1947
B) 1964
C) 1979
D) 1996
Correct Answer: A) 1947
Rationale: The Nuremberg Code was established in 1947 following the
Nuremberg Trials of Nazi physicians. It set forth ten principles for
ethical human experimentation, with voluntary informed consent being
the first and most fundamental principle. The Declaration of Helsinki
was established in 1964, and the Belmont Report was published in
1979.
