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MEGA SOCRA CCRP EXAM CONTENT with latest updated questions correctly answered guaranteed success
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MEGA SOCRA CCRP EXAM CONTENT with latest updated questions correctly answered guaranteed success
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MEGASOCRA
CCRP
EXAM
CONTENT
with
latest
updated
questions
correctly
answered
guaranteed
success
5
-
ANS
The
minimum
number
of
IRB
members
Subjects
cannot
be
enrolled
until
IRB/IEC
approval
has
been
obtained
-
ANS
In
a
non-emergency
situation,
under
which
of
the
following
conditions,
if
any,
may
subjects
be
enrolled
into
a
study
prior
to
IRB/IEC
approval?
The
Sponsor
-
ANS
The
responsibility
for
ensuring
that
the
investigator
understands
a
clinical
trial
lies
with:
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?
-
ANS
This
subject
should
undergo
all
study
procedures
as
outlined
in
the
protocol
A
significant
risk
device
is
defined
as
an
investigational
device
that
is:
-
ANS
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.
With
respect
to
IRB/IEC
membership,
both
the
FDA
and
the
ICH
require
that
-
ANS
At
least
one
member's
primary
area
of
interest
is
in
a
nonscientific
area
The
rights,
safety ,
and
well-being
of
human
subjects
are
protected
-
ANS
A
purpose
of
monitoring
clinical
trials
is
to
verify
that: Which
of
the
following
is
the
proper
way
to
make
a
correction
to
a
CRF?
-
ANS
Add
the
initials
of
the
person
making
the
change,
the
date
of
the
change,
and,
if
necessary ,
a
brief
explanation
of
the
change.
What
details
need
to
be
documented
in
the
subject
source
documentation
when
an
Adverse
Event
(AE)
occurs?
Select
all
that
apply
-
ANS
A.
The
severity
of
the
event
B.
When
the
event
occurred
C.
Setting
in
which
the
event
occurred
What
is
an
Unexpected
Adverse
drug
reaction?
-
ANS
A
reaction
that
is
not
consistent
with
the
applicable
product
information
The
terms
"serious"
and
"severe"
are
synonymous
according
to
ICH.
-
ANS
FALSE
A
serious
adverse
event
is
any
untoward
medical
occurrence
which
at
any
dose
is
best
described
by
which
of
the
following
statements?
Select
all
that
apply
-
ANS
A.
Results
in
death
B.
Is
life-threatening
C.
Is
a
congenital
anomaly
.
Which
of
the
following
options
describes
the
term
"severe"
in
regards
to
ICH?
-
ANS
The
Intensity
of
a
specific
event
Subject
3826
had
to
stay
in
the
hospital
for
three
extra
days
when
his
legs
started
swelling
after
participation
in
a
cardiac
drug
study .
Swelling
of
the
legs
was
listed
in
the
Investigator's
Brochure
as
a
possible
side
effect.
Which
of
the
following
options
best
describes
this
situation?
-
ANS
Serious
Adverse
Drug
Reaction
A
subject
in
your
diabetes
research
study
developed
colon
cancer ,
which
the
Investigator
has
determined
to
be
unrelated
to
the
study .
The
subject
is
currently
asymptomatic.
This
will
be
considered
a
serious
adverse
event
because
it
is
life
threatening.
Is
this
a
true
or
false
statement?
-
ANS
FALSE
In
pre-market
approval
studies,
all
noxious
and
unintended
responses
to
a
medicinal
product,
even
possibly
related
to
any
dose,
should
be
considered
which
of
the
following
options?
-
ANS
Adverse
Drug
Reaction
A
subject
has
a
suspected
serious
adverse
drug
reaction
with
the
outcome
of
death.
Per
the
ICH
E2A
guideline,
which
are
items
that
should
be
submitted
to
the
Sponsor?
-
ANS
1.
A
de-identified
autopsy
report,
if
available 2.
Cause
of
death,
and
a
comment
on
its
possible
relationship
to
the
suspected
drug
reaction
Two
weeks
after
starting
an
investigational
therapy ,
a
subject
is
rushed
to
the
hospital
after
experiencing
a
heart
attack.
The
subject
is
currently
being
treated
in
the
Intensive
Care
Unit
(ICU).
The
ICU
doctor
has
noticed
that
the
subject
was
enrolled
in
the
trial
and
has
contacted
the
trial
Principal
Investigator .
Heart
attack
is
not
described
in
the
Investigator's
Brochure.
What
actions
must
be
taken
by
the
Principal
Investigator?
-
ANS
1.
Report
to
the
Sponsor
per
the
protocol
timelines
for
serious,
unexpected
events.
2.
Report
to
the
IRB/IEC
per
their
event
reporting
requirements
for
serious,
unexpected
events.
What
is
the
timeframe
for
"expedited"
reporting
of
serious,
fatal
or
life-threatening,
unexpected
adverse
drug
reactions
to
regulatory
authorities?
-
ANS
As
soon
as
possible,
but
no
later
than
seven
calendar
days
after
first
knowledge
of
the
event
Adverse
Drug
Reaction
(ADR)
Example
-
ANS
Your
third
subject
in
a
Phase
III
drug
trial
calls
to
report
that
she
has
developed
a
rash
on
her
chest
12
hours
after
taking
her
second
dose
of
the
investigational
study
drug.
She
states
that
it
itches
and
is
slightly
uncomfortable.
She
tells
you
that
she
has
never
had
a
rash
and
this
is
totally
unexpected.
You
know
from
the
Investigator
Drug
Brochure
that
only
12%
of
the
patients
get
a
rash
from
this
drug.
Which
of
the
following
options
best
describes
this
situation?
What
is
the
purpose
of
the
IRB/IEC?
-
ANS
Safeguard
the
rights,
safety ,
and
well-being
of
all
trial
subjects
Who
is
responsible
for
designing
the
clinical
trial
protocol?
-
ANS
Sponsor
Informed
Consent
Process
-
ANS
The
process
by
which
a
subject
voluntarily
confirms
his
or
her
willingness
to
participate
in
a
clinical
trial
is
best
described
as
which
of
the
following
options?
The
Monitor
-
ANS
Who
is
ultimately
responsible
for
Source
Data
Verification
or
SDV?
A.
At
least
five
members
B.
At
least
one
member
whose
primary
interest
is
non-scientific C.
At
least
one
member
who
is
independent
from
the
Institution/trial
site
-
ANS
The
IRB/IEC
should
consist
of
a
reasonable
number
of
members,
who
collectively
have
the
qualifications
and
experience
to
review
and
evaluate
the
science,
medical
aspects,
and
ethics
of
the
proposed
trial.
It
is
recommended
that
the
IRB/IEC
should
include
which
of
the
following
options?
Which
of
the
following
is
NOT
one
of
the
required
elements
of
an
informed
consent
form?
-
ANS
A
listing
of
all
site
personnel
who
will
be
involved
in
the
research
Name
3
of
several
required
elements
of
an
informed
consent
form
-
ANS
1.
The
purpose
of
the
research
2.
A
description
of
benefits
that
may
be
reasonably
expected
from
the
research
3.
A
contact
person
for
questions
about
the
research
According
to
ICH
E6,
who
must
sign
the
Informed
Consent
Form
or
ICF?
-
ANS
The
person
who
conducted
the
informed
consent
discussion
The
subject
or
the
subject's
legally
acceptable
representative
As
per
ICH
E6
GCP ,
which
groups
of
potential
subjects
could
be
defined
as
"vulnerable
subjects"?
-
ANS
Members
of
the
armed
forces
Patients
with
incurable
diseases
Persons
in
nursing
homes
As
per
ICH
E6
GCP ,
patients
with
heart
conditions
alone
are
defined
as
"vulnerable
subjects"?
-
ANS
False
A
subject,
who
has
been
100%
compliant
thus
far,
has
forgotten
to
bring
her
medication
back
to
the
clinic
for
her
regular
visit.
She
reports
that
she
has
not
missed
any
doses
and
has
been
fully
compliant
with
the
protocol.
What
is
the
most
appropriate
action
for
the
investigator
or
clinical
research
coordinator
to
take?
-
ANS
Document
that
the
subject
has
forgotten
to
return
her
medication
in
the
source
document
and
ask
her
to
bring
the
medication
back
to
the
clinic
as
soon
as
possible
or
during
her
next
visit.
A
study
subject
reports
that
he
has
been
having
headaches
for
years
but
they
seem
to
have
become
more
frequent
since
starting
the
study
drug.
The
principal
investigator
believes
that
the
headaches
are
not
related
to
the
study
medication.
How
should
the
event
be
reported?
-
ANS
Adverse
event,
since
the
headaches
have
become
more
frequent
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