SoCRA Certification Exam| 140 QUESTIONS|
WITH COMPLETE SOLUTION
Biometrics Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct Answer: The scripted name or legal mark of an individual
handwritten by that individual. (21 CFR, Sec. 11.3)
Act Correct Answer: The Food, Drug and Cosmetic Act, as amended.
Human Subject Correct 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 Correct 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) Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 blood or affinity whose close association with the subject is
equivalent of a family relationship. (21 CFR, sec. 50.3)
WITH COMPLETE SOLUTION
Biometrics Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 Correct Answer: The scripted name or legal mark of an individual
handwritten by that individual. (21 CFR, Sec. 11.3)
Act Correct Answer: The Food, Drug and Cosmetic Act, as amended.
Human Subject Correct 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 Correct 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) Correct 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 Correct 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 Correct 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 Correct 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 Correct 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 blood or affinity whose close association with the subject is
equivalent of a family relationship. (21 CFR, sec. 50.3)
