SoCRA CERTIFICATION EXAM QUESTIONS AND ANSWERS (VERIFIED
SoCRA Certification Exam
AND WELL DETAILED ANSWERS) LATEST UPDATE 2024/2025
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1. Biometrics 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)
2. Closed System An environment in which system access is controlled by persons who are respon-
sible for the content of electronic records that are on the system. (21 CFR, Sec.
11.3)
3. Digital Signature An electronic signature based upon cryptographic methods of originator authen-
tication, 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)
4. Electronic Record 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)
5. Electronic Signa- A computer data compilation of any symbol or series of symbols executed,
ture adopted, or authorized by an individual to be legally binding equivalent of the
handwritten signature. (21 CFR, Sec. 11.3)
6. Open system 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)
7. Clinical Investi- Any experiment that involves a test article and one or more human subjects and
gation that either is subject to requirements for prior submission to the Food and Drug
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)
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8. Investigator 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)
9. Sponsor A person who initiates a clinical investigation but 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
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)
10. Sponsor-Investi- An individual who both initiates and actually conducts, alone or with others, a
gator 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)
11. Handwritten Sig- The scripted name or legal mark of an individual handwritten by that individual.
nature (21 CFR, Sec. 11.3)
12. Act The Food, Drug and Cosmetic Act, as amended.
13. Human Subject 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)
14. Institution 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)
15.
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Institutional Re- Any board, committee, or other group formally designated by an institution to
view Board (IRB) 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)
16. Test Article Any food or drug (including a biological product for human use), medical device
for human use, human 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)
17. Minimal Risk 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 exam-
inations or tests. (21 CFR, sec. 50.3)
18. Legally Autho- An individual or judicial or other body authorized under applicable law to consent
rized Represen- on behalf of a prospective subject to the subject's participation in the procedures
tative involved. (21 CFR, sec. 50.3)
19. Family Member 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)
20. Assent 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)
21. Children Persons who have not attained the legal age for consent to treatment or proce-
dures involved in clinical investigations, under the applicable law of the jurisdic-
tion in which the clinical investigation will be conducted. (21 CFR, sec. 50.3)
SoCRA Certification Exam
AND WELL DETAILED ANSWERS) LATEST UPDATE 2024/2025
Study online at https://quizlet.com/_94xuw
1. Biometrics 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)
2. Closed System An environment in which system access is controlled by persons who are respon-
sible for the content of electronic records that are on the system. (21 CFR, Sec.
11.3)
3. Digital Signature An electronic signature based upon cryptographic methods of originator authen-
tication, 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)
4. Electronic Record 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)
5. Electronic Signa- A computer data compilation of any symbol or series of symbols executed,
ture adopted, or authorized by an individual to be legally binding equivalent of the
handwritten signature. (21 CFR, Sec. 11.3)
6. Open system 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)
7. Clinical Investi- Any experiment that involves a test article and one or more human subjects and
gation that either is subject to requirements for prior submission to the Food and Drug
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)
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8. Investigator 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)
9. Sponsor A person who initiates a clinical investigation but 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
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)
10. Sponsor-Investi- An individual who both initiates and actually conducts, alone or with others, a
gator 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)
11. Handwritten Sig- The scripted name or legal mark of an individual handwritten by that individual.
nature (21 CFR, Sec. 11.3)
12. Act The Food, Drug and Cosmetic Act, as amended.
13. Human Subject 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)
14. Institution 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)
15.
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Institutional Re- Any board, committee, or other group formally designated by an institution to
view Board (IRB) 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)
16. Test Article Any food or drug (including a biological product for human use), medical device
for human use, human 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)
17. Minimal Risk 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 exam-
inations or tests. (21 CFR, sec. 50.3)
18. Legally Autho- An individual or judicial or other body authorized under applicable law to consent
rized Represen- on behalf of a prospective subject to the subject's participation in the procedures
tative involved. (21 CFR, sec. 50.3)
19. Family Member 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)
20. Assent 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)
21. Children Persons who have not attained the legal age for consent to treatment or proce-
dures involved in clinical investigations, under the applicable law of the jurisdic-
tion in which the clinical investigation will be conducted. (21 CFR, sec. 50.3)
