SOCRA CCRP Certification Exam
Study Guide Update.
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)
Study Guide Update.
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)
