WELL DETAILED ANSWERS|LATEST
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, CORRECT WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
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)
2
, 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.
3
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, CORRECT WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
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)
2
, 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.
3
