Exam (elaborations)
CCRP SOCRA Exam - Practice Exam #1 questions and answers
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CCRP SOCRA Exam - Practice Exam #1 questions and answers
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CCRPSOCRA
Exam
-
Practice
Exam
#1
questions
and
answers
The
responsibility
for
ensuring
that
the
investigator
understands
a
clinical
trial
lies
with
which
individual/or
organization?
A)
FDA
B)
IRB
C)
Sponsor
D)
Coordinator
C)
Sponsor
What
is
the
minimum
number
of
IRB
Members?
A)
3
B)
5
C)
6
D)
10
B)
5
A
significant
risk
device
is
defined
as
an
investigational
device
that
is:
A)
Intended
as
an
implant
and
presents
a
potential
for
serious
risk
to
the
health,
safety,
or
welfare
of
a
subject
B)
Purported
or
represented
to
be
for
a
use
in
supporting
or
sustaining
human
life
and
presents
a
potential
risk
to
the
health,
safety,
or
welfare
of
a
subject
C)
For
a
use
of
substantial
importance
in
diagnosing,
curing,
mitigating,
or
treating
disease,
or
otherwise
preventing
impairment
of
human
health
and
presents
a
potential
for
serious
risk
to
the
health,
safety,
or
welfare
of
a
subject.
D)
All
the
above
D
)
All
of
the
above
With
respect
to
IRB/IEC
membership,
both
the
FDA
and
the
ICH
require
that: A)
A
majority
of
the
members'
primary
area
of
interest
is
in
a
scientific
area
B)
At
least
one
member
holds
a
Ph.D.
degree
or
equivalent
C)
At
least
one
member's
primary
area
of
interest
is
in
a
nonscientific
area
D)
A
majority
of
the
members
are
from
or
have
ties
to
the
institution
of
record
C)
At
least
one
member's
primary
area
of
interest
is
in
a
nonscientific
area
In
a
non-emergency
situation,
under
which
of
the
following
conditions,
if
any,
may
subjects
been
rolled
into
a
study
prior
to
IRB/IEC
approval?
A)
The
investigator
provides
his/her
written
approval
B)
The
study
drug
has
an
FDA
approved
marketing
application
C)
The
FDA
provides
written
approval
of
the
IND
D)
Subjects
cannot
be
enrolled
until
IRB/IEC
approval
has
been
obtained
D)
Subjects
cannot
be
enrolled
until
IRB/IEC
approval
has
been
obtained
A
subject
has
been
enrolled
on
a
study
and
was
randomized
to
the
non-treatment
arm.
The
protocol
outlines
study
procedures
for
all
subjects
to
be
performed
within
one
week
of
enrollment.
Which
of
the
following
statements
about
this
case
is
correct?
A)
This
subject
does
not
need
to
undergo
any
of
the
study
procedures
since
the
subject
is
enrolled
on
the
non-treatment
arm
B)
This
subject
should
undergo
all
study
procedures
as
outlined
in
the
protocol
C)
This
subject
only
needs
to
undergo
the
study
procedures
that
pertain
specifically
to
the
subject
D)
This
subject
can
undergo
the
study
procedures
whenever
it
is
convenient
B)
This
subject
should
undergo
all
study
procedures
as
outlined
in
the
protocol
A
purpose
of
monitoring
clinical
trials
is
to
verify
that:
A)
The
rights,
safety,
and
well-being
of
human
subjects
are
protected
B)
Investigators
receive
adequate
payment
for
their
participation
in
the
clinical
trial
C)
The
investigator
has
received
annual
reports
from
the
sponsor
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