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SOCRA Certification questions with complete solution Investigator should (qualifications/agreements) - correct answer-Be qualified by training/education and expertise Be familiar with the product investigational Be aware and comply with GCP and regulatory requirements Permit auditing/mo...

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SOCRA
Certification
questions
with
complete
solution
Investigator
should
(qualifications/agreements)
-
correct
answer-Be
qualified
by
training/education
and
expertise
Be
familiar
with
the
product
investigational
Be
aware
and
comply
with
GCP
and
regulatory
requirements
Permit
auditing/monitoring
Delegate
authority
and
maintain
a
log
Be
responsible
for
the
training
of
the
staff
Nuremberg
Code
-
correct
answer-(1947)
Ten
guidelines
for
the
ethical
treatment
of
human
subjects
in
research
-
Came
about
after
Nuremberg
trial
in
Germany
during
world
war
II
Legal
force
of
the
document
was
NOT
established
or
incorporated
directly
into
the
American
or
German
law
Nuremberg
Code
10
Ethical
Guidelines
-
correct
answer-1.
Voluntary
consent
of
the
human
subject
is
absolutely
essential.
2.
The
experiment
should
be
such
as
to
productive
results
for
the
good
of
society
unprocuable
by
other
methods
or
means
and
not
ransom
and
unnecessary
in
nature.
3.
The
experiment
should
be
so
designed
and
based
on
the
results
of
animal
experimentation
and
a
knowledge
of
the
natural
history
of
the
disease.
4.
The
experiment
should
be
so
conducted
as
to
avoid
all
unnecessary
physical
and
mental
suffering
and
injury.
5.
No
experiment
should
be
conducted
where
there
is
an
a
prior
reason
to
believe
that
death
or
disabling
injury
will
occur.
6.
The
degree
of
risk
to
be
taken
should
never
exceed
that
determined
by
the
humanitarian
importance
of
the
problem
to
be
solved
by
the
experiment.
7.
Proper
preparations
should
be
made
and
adequate
facilities
provided
to
protect
the
experimental
subject
against
even
remote
possibilities
of
injury,
disability,
or
death.
8.
The
experiment
should
be
conducted
only
by
scientifically
qualified
persons.
The
highest
degree
of
skill
and
care.
9.
During
the
course
of
the
experiment
the
human
subject
should
be
at
liberty
to
bring
the
experiment
to
an
end.
10.
During
the
course
of
the
experiment
the
scientist
in
charge
must
be
prepared
to
terminate
the
experiment
at
any
stage.
Nuremberg
Code
-
Key
Principles
-
correct
answer-1.
Voluntary
participation 2.
Informed
Consent
3.
Minimization
of
risk
The
Nuremberg
Code
and
the
Declaration
of
Helsinki
are
the
basis
for
the...
-
correct
answer-Code
of
Federal
Regulations
Title
45
Volume
46
which
are
regulations
issued
by
the
United
states
department
of
heath
and
human
services
Declaration
of
Helsinki
-
correct
answer-(1964)
Is
a
set
of
ethical
principles
regarding
human
experimentation
developed
for
the
medical
community
by
the
WMA
(World
Medical
Association).
Declaration
is
addressed
primarily
to
physicians.
The
WMA
(World
Medical
Association)
encourages
others
who
are
involved
in
medical
research
involving
human
subjects
to
adopt
these
principles.
Not
legally
mandated
Declaration
of
Helsinki
Key
Principles
-
correct
answer-1.
Well-being
of
subjects
takes
precedence
2.
Respect
for
persons
3.
Protection
of
subjects
heath
and
rights
5.
Special
protection
for
vulnerable
populations
Declaration
of
Helsinki
has
undergone..
-
correct
answer-7
revisions
and
2
clarifications
-
first
in
Finland
in
June
1964
Who
developed
the
Declaration
of
Helsinki
and
why
-
correct
answer-The
World
Medical
Associated
(WMA)
-
as
a
statement
of
ethical
principals
for
medical
research
involving
human
subjects,
including
research
on
identifiable
human
material
and
data
General
Principals
of
the
Declaration
of
Helsinki
-
correct
answer-1.
"the
health
of
my
patient
will
be
my
first
consideration"
2.
It
is
the
duty
of
the
clinician
to
promote
and
safeguard
the
health,
well-being
and
rights
of
patients
3.
Medical
progress
is
based
on
research
that
ultimately
must
include
studies
involving
human
subjects
4.
The
primary
purpose
of
medical
research
involving
human
subjects
is
to
understand
the
causes,
development
and
effects
of
diseases
5.
Medical
research
is
subject
to
ethical
standards
that
promote
and
ensure
respect
for
all
human
subjects
and
protect
their
heath
and
rights
6.
While
the
primary
purpose
of
medical
research
is
to
generate
new
knowledge,
this
goal
can
never
take
precedence
over
the
rights
and
interests
of
individual
research
subjects
7.
It
is
the
duty
of
clinicians
who
are
involved
in
medical
research
to
protect
the
life,
health,
dignity,
integrity,
right
to
self-determination,
privacy,
and
confidentiality
of
personal
information
of
research
subjects 8.
Physicians
must
consider
the
ethical,
legal
and
regulatory
norms
and
standards
for
research
involving
human
subjects
in
their
own
countries
as
well
as
applicable
international
norms
and
standards
9.
Medical
research
must
be
conducted
in
a
manner
that
minimizes
possible
harm
to
the
environment
10.
Medical
research
involving
human
subjects
must
be
conducted
only
by
individuals
with
the
appropriate
ethics
and
and
scientific
education,
training
and
qualifications
11.
Groups
that
are
underrepresented
in
medical
research
should
be
provided
appropriate
access
to
participation
in
research
12.
Physicians
who
combine
medical
research
with
medical
care
should
involve
their
patients
in
research
only
to
the
extent
that
is
justified
by
its
potential
preventative,
diagnostic
or
therapeutic
value
13.
Appropriate
compensation
and
treatment
for
subjects
who
are
harmed
as
a
result
of
participating
in
resear
The
Belmont
Report
-
correct
answer-April
18th,
1979
1.
Respect
for
persons-informed
consent,
protection
of
vulnerable
populations
2.
Beneficence-non
malfeasance
3.
Justice-fairness
These
principles
remain
the
basis
for
the
United
States
Department
of
Health
and
Human
Services
(HSS)
Human
Subject
Protection
regulations
The
Belmont
report
was
created/established
by...
-
correct
answer-The
National
Commission
for
the
Protection
of
Human
Subjects
of
Biomedical
and
Behavioral
Research
in
1979
Prompted
from
the
Tuskegee-Syphilis
Study
(1932-1972)
Tuskegee
Syphilis
Study
-
correct
answer-(1932-1972)
prompted
the
belmont
report
Conducted
by
the
US
Public
Heath
Service
to
study
the
natural
progression
of
untreated
syphilis
in
rural
African
american
men
who
thought
they
were
receiving
free
healthcare
from
the
US
government
In
1947
the
treatment
for
syphilis
(penicillin)
had
become
standard
trx
-
the
experiment
continued
The
Belmont
Report
continues
as
an
essential
reference
for
IRB
-
correct
answer-1.
They
must
make
sure
the
study
is
approved
by
an
IRB
2.
Get
Informed
consent
from
the
patient
3.
Be
sure
that
the
patient
understands
the
full
extent
to
the
experiment,
and
if
not
contact
the
study
coordinator
4.
Make
sure
the
patient
wasnt
coerced
into
doing
the
experiment
by
means
of
threatening
or
bullying

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