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SoCRA Certification Exam Questions and
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Biometrics— Ans: A method of verifying an individual's identity
based on measurement of the individual's physical features or
repeatable actions where those features and or actions are both
unique to that individual and measurable. (21 CFR, Sec. 11.3)
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Closed System— Ans: An environment in which system access is
controlled by persons who are responsible for the content of
electronic records that are on the system. (21 CFR, Sec. 11.3)
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Digital Signature— Ans: An electronic signature based upon
cryptographic methods of originator authentication, computed
by using a set of rules and a set of parameters such that the
identity of the signer and the integrity of the data can be verified.
(21 CFR, Sec. 11.3)
Electronic Record— Ans: Any combination of text, graphics,
data, audio, pictorial, or other information representation in digital
form that is created, modified, maintained, archived, retrieved or
distributed by a computer system. (21 CFR, Sec. 11.3)
Electronic Signature— Ans: A computer data compilation of any
symbol or series of symbols executed, adopted, or authorized by
an individual to be legally binding equivalent of the handwritten
signature. (21 CFR, Sec. 11.3)
Open system— Ans: An environment in which system access is
not controlled by persons who are responsible for the content of
the electronic records that are on the system. (21 CFR, Sec. 11.3)
Clinical Investigation— Ans: Any experiment that involves a test
article and one or more human subjects and that either is subject
to requirements for prior submission to the Food and Drug
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Administration under section 505(i) or 520(g) of the act, or is not
subject to requirements for prior submission to the Food and Drug
Administration under these sections of the Act, but the results of
which are intended to be submitted later to, or held for inspection
by, the Food and Drug Administration as part of an application for
a research or marketing permit. (21 CFR, sec. 50.3)
Investigator— Ans: An individual who actually conducts a clinical
investigation, i.e., under whose immediate direction the test article
is administered or dispensed to, or used involving, a subject, or, in
the event of an investigation conducted by a team of individuals,
is the responsible leader of that team. (21 CFR, sec. 50.3)
Sponsor— Ans: A person who initiates a clinical investigation but
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who does not actually conduct the investigation, i.e., the test
article is administered or dispensed to, or used involving, a subject
under the immediate direction of another individual. A person
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other than the individual (e.g., corporation or agency) that uses
one or more of its own employees to conduct a clinical
investigation it has initiated it has initiated is considered to be a
sponsor (not a sponsor-investigator), and the employees are
considered to be investigators. (21 CFR, sec. 50.3)
Sponsor-Investigator— Ans: An individual who both initiates and
actually conducts, alone or with others, a clinical investigation,
i.e., under whose immediate direction the test article is
administered or dispensed to, or used involving, a subject. The
term does not include any other person other than an individual,
e.g. corporation or agency. (21 CFR, sec. 50.3)
Handwritten Signature— Ans: The scripted name or legal mark of
an individual handwritten by that individual. (21 CFR, Sec. 11.3)
Act— Ans: The Food, Drug and Cosmetic Act, as amended.
Human Subject— Ans: An individual who is or becomes a
participant in research, either as a recipient of the test article or as
a control. A subject may be either a healthy human or a patient.
(21 CFR, sec. 50.3)
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Institution— Ans: Any public or private entity or agency (including
Federal, State or other agencies). The word facility as used in
section 520(g) of the Act is deemed to by synonymous with the
term institution for purposes of this part.(21 CFR, sec. 50.3)
Institutional Review Board (IRB)— Ans: Any board, committee, or
other group formally designated by an institution to review
biomedical research involving humans as subjects, to approve the
initiation of and conduct periodic review of such research. The
term has the same meaning as the phrase institutional review
committee as used in section 520(g) of the act. (21 CFR, sec. 50.3)
Test Article— Ans: Any food or drug (including a biological
product for human use), medical device for human use, human
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food additive, color additive, electronic product, or any other
article subject to regulation under the act or under sections 351,
and 354-360F of the Public Health Services Act. (21 CFR, sec. 50.3)
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Minimal Risk— Ans: Means that the probability and magnitude of
harm or discomfort anticipated in the research are no greater in
an of themselves than those ordinarily encountered in daily life or
during the performance of routine physical or psychological
examinations or tests. (21 CFR, sec. 50.3)
Legally Authorized Representative— Ans: An individual or judicial
or other body authorized under applicable law to consent on
behalf of a prospective subject to the subject's participation in the
procedures involved. (21 CFR, sec. 50.3)
Family Member— Ans: Any one of the following legally
competent persons: spouse; parents; children (including adopted
children); brothers, sisters and spouses of brothers and sisters; and
any individual related by blood or affinity whose close association
with the subject is equivalent of a family relationship. (21 CFR, sec.
50.3)
Assent— Ans: A child's affirmative agreement to participate in a
clinical investigation. Mere failure to object may not, absent
affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
For Expert help and assignment solutions, +254707240657
SoCRA Certification Exam Questions and
Answers (100% Correct Answers) Already
Graded A+
Biometrics— Ans: A method of verifying an individual's identity
based on measurement of the individual's physical features or
repeatable actions where those features and or actions are both
unique to that individual and measurable. (21 CFR, Sec. 11.3)
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Closed System— Ans: An environment in which system access is
controlled by persons who are responsible for the content of
electronic records that are on the system. (21 CFR, Sec. 11.3)
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Digital Signature— Ans: An electronic signature based upon
cryptographic methods of originator authentication, computed
by using a set of rules and a set of parameters such that the
identity of the signer and the integrity of the data can be verified.
(21 CFR, Sec. 11.3)
Electronic Record— Ans: Any combination of text, graphics,
data, audio, pictorial, or other information representation in digital
form that is created, modified, maintained, archived, retrieved or
distributed by a computer system. (21 CFR, Sec. 11.3)
Electronic Signature— Ans: A computer data compilation of any
symbol or series of symbols executed, adopted, or authorized by
an individual to be legally binding equivalent of the handwritten
signature. (21 CFR, Sec. 11.3)
Open system— Ans: An environment in which system access is
not controlled by persons who are responsible for the content of
the electronic records that are on the system. (21 CFR, Sec. 11.3)
Clinical Investigation— Ans: Any experiment that involves a test
article and one or more human subjects and that either is subject
to requirements for prior submission to the Food and Drug
, 2
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Administration under section 505(i) or 520(g) of the act, or is not
subject to requirements for prior submission to the Food and Drug
Administration under these sections of the Act, but the results of
which are intended to be submitted later to, or held for inspection
by, the Food and Drug Administration as part of an application for
a research or marketing permit. (21 CFR, sec. 50.3)
Investigator— Ans: An individual who actually conducts a clinical
investigation, i.e., under whose immediate direction the test article
is administered or dispensed to, or used involving, a subject, or, in
the event of an investigation conducted by a team of individuals,
is the responsible leader of that team. (21 CFR, sec. 50.3)
Sponsor— Ans: A person who initiates a clinical investigation but
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who does not actually conduct the investigation, i.e., the test
article is administered or dispensed to, or used involving, a subject
under the immediate direction of another individual. A person
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other than the individual (e.g., corporation or agency) that uses
one or more of its own employees to conduct a clinical
investigation it has initiated it has initiated is considered to be a
sponsor (not a sponsor-investigator), and the employees are
considered to be investigators. (21 CFR, sec. 50.3)
Sponsor-Investigator— Ans: An individual who both initiates and
actually conducts, alone or with others, a clinical investigation,
i.e., under whose immediate direction the test article is
administered or dispensed to, or used involving, a subject. The
term does not include any other person other than an individual,
e.g. corporation or agency. (21 CFR, sec. 50.3)
Handwritten Signature— Ans: The scripted name or legal mark of
an individual handwritten by that individual. (21 CFR, Sec. 11.3)
Act— Ans: The Food, Drug and Cosmetic Act, as amended.
Human Subject— Ans: An individual who is or becomes a
participant in research, either as a recipient of the test article or as
a control. A subject may be either a healthy human or a patient.
(21 CFR, sec. 50.3)
, 3
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Institution— Ans: Any public or private entity or agency (including
Federal, State or other agencies). The word facility as used in
section 520(g) of the Act is deemed to by synonymous with the
term institution for purposes of this part.(21 CFR, sec. 50.3)
Institutional Review Board (IRB)— Ans: Any board, committee, or
other group formally designated by an institution to review
biomedical research involving humans as subjects, to approve the
initiation of and conduct periodic review of such research. The
term has the same meaning as the phrase institutional review
committee as used in section 520(g) of the act. (21 CFR, sec. 50.3)
Test Article— Ans: Any food or drug (including a biological
product for human use), medical device for human use, human
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food additive, color additive, electronic product, or any other
article subject to regulation under the act or under sections 351,
and 354-360F of the Public Health Services Act. (21 CFR, sec. 50.3)
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Minimal Risk— Ans: Means that the probability and magnitude of
harm or discomfort anticipated in the research are no greater in
an of themselves than those ordinarily encountered in daily life or
during the performance of routine physical or psychological
examinations or tests. (21 CFR, sec. 50.3)
Legally Authorized Representative— Ans: An individual or judicial
or other body authorized under applicable law to consent on
behalf of a prospective subject to the subject's participation in the
procedures involved. (21 CFR, sec. 50.3)
Family Member— Ans: Any one of the following legally
competent persons: spouse; parents; children (including adopted
children); brothers, sisters and spouses of brothers and sisters; and
any individual related by blood or affinity whose close association
with the subject is equivalent of a family relationship. (21 CFR, sec.
50.3)
Assent— Ans: A child's affirmative agreement to participate in a
clinical investigation. Mere failure to object may not, absent
affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
