NAPSR
Exam
Quiz
11,
Chapter
11
(Complete
with
A+
Rated
Answers)
According
to
NIH
ethical
guidelines,
which
of
the
following
is
the
most
important
criteria
in
selecting
subjects
for
clinical
studies?
-
ANSWER-scientific
objectives
Which
statement
about
the
IRB
is
INCORRECT?
-
ANSWER-The
members
of
the
IRB/IEC
must
be
experts
in
the
topic
of
the
study
Which
phases
of
clinical
studies
are
"open
label"
and
which
are
blinded?
-
ANSWER-Phase
I
and
IV
trials
are
often
open
label,
but
Phase
II
and
III
are
double
blinded
or
at
least
blinded
If
it
is
not
possible
to
measure
the
direct
effects
of
a
drug,
what
is
used
instead?
-
ANSWER-surrogate
markers
such
as
blood
pressure
and
cholesterol
levels
Which
of
the
following
is
an
observational
study
that
first
identifies
a
group
of
subjects
with
a
certain
disease
and
a
control
group
without
the
disease,
and
then
looks
to
back
in
time
(e.g.
via
chart
reviews)
to
find
exposure
to
risk
factors?
-
ANSWER-case-control
study
Which
measure
of
central
tendency
is
the
sum
of
all
observations
divided
by
the
number
of
observations?
-
ANSWER-mean
Which
measurement
describes
the
number
of
new
events
that
occur
during
a
specified
period
of
time
in
a
population
at
risk
for
the
event
(e.g.,
lung
infections
per
year)?
-
ANSWER-incidence
Which
of
the
following
measures
is
used
to
describe
the
variability
of
the
population
mean?
-
ANSWER-standard
error
of
the
mean
Exam
Quiz
11,
Chapter
11
(Complete
with
A+
Rated
Answers)
According
to
NIH
ethical
guidelines,
which
of
the
following
is
the
most
important
criteria
in
selecting
subjects
for
clinical
studies?
-
ANSWER-scientific
objectives
Which
statement
about
the
IRB
is
INCORRECT?
-
ANSWER-The
members
of
the
IRB/IEC
must
be
experts
in
the
topic
of
the
study
Which
phases
of
clinical
studies
are
"open
label"
and
which
are
blinded?
-
ANSWER-Phase
I
and
IV
trials
are
often
open
label,
but
Phase
II
and
III
are
double
blinded
or
at
least
blinded
If
it
is
not
possible
to
measure
the
direct
effects
of
a
drug,
what
is
used
instead?
-
ANSWER-surrogate
markers
such
as
blood
pressure
and
cholesterol
levels
Which
of
the
following
is
an
observational
study
that
first
identifies
a
group
of
subjects
with
a
certain
disease
and
a
control
group
without
the
disease,
and
then
looks
to
back
in
time
(e.g.
via
chart
reviews)
to
find
exposure
to
risk
factors?
-
ANSWER-case-control
study
Which
measure
of
central
tendency
is
the
sum
of
all
observations
divided
by
the
number
of
observations?
-
ANSWER-mean
Which
measurement
describes
the
number
of
new
events
that
occur
during
a
specified
period
of
time
in
a
population
at
risk
for
the
event
(e.g.,
lung
infections
per
year)?
-
ANSWER-incidence
Which
of
the
following
measures
is
used
to
describe
the
variability
of
the
population
mean?
-
ANSWER-standard
error
of
the
mean