SOCRA CERTIFICATION EXAM
QUESTIONS WITH 100% CORRECT
ANSWERS | LATEST VERSION 2025/2026.
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)
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)
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)
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
,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 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 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)
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.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
, 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)
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 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)
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)
3 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
QUESTIONS WITH 100% CORRECT
ANSWERS | LATEST VERSION 2025/2026.
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)
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)
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)
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
,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 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 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)
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.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
, 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)
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 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)
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)
3 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED
