SoCRA Certification Exam Complete
Questions with Graded A+ Answers
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)
Questions with Graded A+ Answers
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)
