SoCRA CERTIFICATION EXAM
QUESTIONS WITH VERIFIED ANSWERS
\.Biometrics - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-The scripted name or legal mark of
an individual handwritten by that individual. (21 CFR, Sec. 11.3)
\.Act - ANSWERS-The Food, Drug and Cosmetic Act, as amended.
\.Human Subject - ANSWERS-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)
QUESTIONS WITH VERIFIED ANSWERS
\.Biometrics - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-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 - ANSWERS-The scripted name or legal mark of
an individual handwritten by that individual. (21 CFR, Sec. 11.3)
\.Act - ANSWERS-The Food, Drug and Cosmetic Act, as amended.
\.Human Subject - ANSWERS-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)
