SoCRA Certification Exam 2026 SOCRA
Certification Actual Exam 2026 Questions
and Correct Answers Rated A+
Biometrics -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-The scripted name or legal mark of an
individual handwritten by that individual. (21 CFR, Sec. 11.3)
Act -Answer-The Food, Drug and Cosmetic Act, as amended.
, Human Subject -Answer-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 -Answer-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) -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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
Certification Actual Exam 2026 Questions
and Correct Answers Rated A+
Biometrics -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-The scripted name or legal mark of an
individual handwritten by that individual. (21 CFR, Sec. 11.3)
Act -Answer-The Food, Drug and Cosmetic Act, as amended.
, Human Subject -Answer-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 -Answer-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) -Answer-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 -Answer-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 -Answer-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 -Answer-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 -Answer-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
