SOCRA CERTIFICATION ACTUAL EXAM 100%
WITH QUESTIONS AND WELL VERIFIED
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)
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.
Human Subject - 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 - 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) - 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)
WITH QUESTIONS AND WELL VERIFIED
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)
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.
Human Subject - 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 - 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) - 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)
