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SOCRA Certification Exam with 100% complete solution latest review graded A+
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SOCRA Certification Exam with 100% complete solution latest review graded A+
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SOCRACertification
Exam
with
100%
complete
solution
latest
review
graded
A+
Biometrics
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
The
scripted
name
or
legal
mark
of
an
individual
handwritten
by
that
individual.
(21
CFR,
Sec.
11.3)
Act
-
ANS
The
Food,
Drug
and
Cosmetic
Act,
as
amended.
Human
Subject
-
ANS
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
-
ANS
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)
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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
-
ANS
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)
Assent
-
ANS
A
child's
affirmative
agreement
to
participate
in
a
clinical
investigation.
Mere
failure
to
object
may
not,
absent
affirmative
agreement,
be
construed
as
assent.
(21
CFR,
sec.
50.3)
Children
-
ANS
Persons
who
have
not
attained
the
legal
age
for
consent
to
treatment
or
procedures
involved
in
clinical
investigations,
under
the
applicable
law
of
the
jurisdiction
in
which
the
clinical
investigation
will
be
conducted.
(21
CFR,
sec.
50.3)
Parent
-
ANS
A
child's
biological
or
adoptive
parent.
(21
CFR,
sec.
50.3)
Ward
-
ANS
A
child
who
is
placed
in
legal
custody
of
the
State
or
other
agency ,
institution,
or
entity ,
consistent
with
applicable
Federal,
State
or
Local
law.
(21
CFR,
sec.
50.3)
Permission
-
ANS
The
agreement
of
the
parent(s)
or
guardian
to
the
participation
of
their
child
or
ward
in
a
clinical
investigation.
Permission
must
be
obtained
in
compliance
with
part
50
subpart
B
and
must
include
all
the
elements
of
the
informed
consent.
(21
CFR,
sec.
50.3)
Guardian
-
ANS
An
individual
who
is
authorized
under
applicable
State
or
local
law
to
consent
on
behalf
of
a
child
to
general
medical
care
when
general
medical
care
includes
research.
(21
CFR,
sec.
50.3) Emergency
Use
-
ANS
The
use
of
a
test
article
on
a
human
subject
in
a
life-threatening
situation
in
which
no
standard
acceptable
treatment
is
available,
and
in
which
there
is
no
sufficient
time
to
obtain
IRB
approval.
(21
CFR,
sec.
56.102)
IRB
Approval
-
ANS
The
determination
of
the
IRB
that
the
clinical
investigation
has
been
reviewed
and
may
be
conducted
at
an
institution
within
the
constraints
set
forth
by
the
IRB
and
by
other
institutional
and
federal
Requirements.
(21
CFR,
sec.
56.102)
Contract
Research
Organization
-
ANS
A
person
that
assumes,
as
an
independent
contractor
with
the
sponsor ,
one
or
more
of
the
obligations
of
a
sponsor ,
e.g.,
design
of
a
protocol,
selection
or
monitoring
of
investigations,
evaluation
of
reports,
and
preparation
of
materials
to
be
submitted
to
the
FDA.
(21
CFR,
sec.
312.3)
IND
-
ANS
An
investigational
new
drug
application.
Is
synonymous
with
"Notice
of
Claimed
Investigational
Exemption
for
a
New
Drug".
(21
CFR,
sec.
312.3)
Independent
Ethics
Committee
(IEC)
-
ANS
A
review
panel
the
is
responsible
for
ensuring
the
protection
of
the
rights,
safety ,
and
well-being
of
human
subjects
involved
in
a
clinical
investigation
and
is
adequately
constituted
to
provide
assurance
of
that
protection.
An
IRB
is
one
type
of
IEC.
(21
CFR,
sec.
312.3)
Custom
Device
-
ANS
A
device
that
1)
necessarily
deviates
from
devices
generally
available
2)
is
not
generally
available
to
Physicians/dentists
3)
not
generally
available
in
finished
form
for
purchase
or
dispensing
4)
is
not
offered
for
commercial
distribution
through
labeling/advertising
5)
is
intended
for
use
by
an
individual
patient
named
in
the
order
of
the
physician
or
dentist
and
is
made
to
be
in
a
specific
form
for
that
patient.
(21
CFR,
sec.
812.3)
Implant
-
ANS
A
device
that
is
placed
into
a
surgically
or
naturally
formed
cavity
of
the
human
body
if
it
is
intended
to
remain
there
for
a
period
of
30
days
or
more.
(21
CFR,
sec.
812.3)
Investigational
Device
-
ANS
A
device,
including
a
transitional
device
that
is
the
object
of
investigation.
(21
CFR,
sec.
812.3)
Monitor
-
ANS
When
used
as
a
noun,
means
an
individual
designated
by
a
sponsor
or
contract
research
organization
to
oversee
the
progress
of
and
investigation.
When
used
as
a
verb,
means
to
oversee
and
investigation.
(21
CFR,
sec.
812.3)
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