SoCRA Certification Exam 2024
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)
Closed System - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ The scripted name or legal mark of an individual
handwritten by that individual. (21 CFR, Sec. 11.3)
Act - ✔✔ The Food, Drug and Cosmetic Act, as amended.
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)
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)
Institutional Review Board (IRB) - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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)
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)
Closed System - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ The scripted name or legal mark of an individual
handwritten by that individual. (21 CFR, Sec. 11.3)
Act - ✔✔ The Food, Drug and Cosmetic Act, as amended.
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)
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)
Institutional Review Board (IRB) - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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 - ✔✔ 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)
