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SOCRA Exam questions and correct answers
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SOCRA Exam questions and correct answers
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SOCRAExam
questions
and
correct
answers
Electronic
Records
-
answer-Use
of
electronic
records
must
have
procedures
to
ensure
the
authenticity,
integrity
and
confidentiality
of
records.
Also,
the
procedures
must
ensure
the
signer
cannot
readily
repudiate
the
signed
records
a
snot
genuine
Electronic
Records
-
Audit
Trail
-
answer-Electronic
records
must
use
secure,
computer
generated,
time-stamped
audit
trails
to
independently
record
the
date
and
time
of
entries
and
actions
that
create,
modify
or
delete
records.
Electronic
Records
-
Changes
-
answer-Record
changes
must
not
obscure
previously
recorded
information
Electronic
Records
-
Audit
Trail
Retention
-
answer-Audit
trail
documentation
must
be
retained
for
a
period
at
least
as
long
as
that
required
for
the
subject
electronic
records
and
must
be
available
for
agency
(FDA)
review
and
copying.
Electronic
records
-
Controls
over
systems
documentation
-
answer-1.
Controls
over
the
distribution
of,
access
to,
and
use
of
documentation
for
system
operation
and
maintenance
2.
Revision
and
change
control
procedures
to
maintain
an
audit
trail
that
documents
time-sequenced
development
and
modification
of
systems
documentation
Electronic
records
-
Open
system
-
answer-Procedures
and
controls
must
be
used
to
ensure
the
authenticity,
integrity
and
confidentiality
of
electronic
records
from
the
point
of
creation
to
the
point
of
receipt.
Examples:
Encryption,
Use
of
digital
signatures
Signed
Electronic
Records
-
answer-Must
contain
information
associated
with
the
signing
that
clearly
indicate
all
of
the
following:
1.
Printed
name
of
signer
2.
Date
and
time
when
signature
was
executed
3.
Meaning
(such
as
review,
approval,
responsibility
or
authorship)
associated
with
signature
Electronic
Signature
Verification
-
answer-Before
any
organization
establishes,
assigns,
certifies
or
otherwise
sanctions
an
individual's
electronic
signature,
the
identity
of
the
individual
must
be
verified Electronic
Signature
Certification
-
answer-Prior
to
using
their
electronic
signature,
one
must
certify
to
the
agency
that
the
electronic
signatures
in
their
system,
used
on
or
after
8/20/97,
are
intended
to
be
the
legally
binding
equivalent
of
traditional
handwritten
signatures
1.
Certification
must
be
submitted
in
paper
form
and
signed
with
a
traditional
handwritten
signature
2.
Upon
agency
request,
must
provide
additional
certification
or
testimony
that
a
specific
electronic
signature
is
the
legally
binding
equivalent
of
the
handwritten
signature
Electronic
Signatures
not
based
on
biometrics
-
answer-1.
Employ
at
least
2
distinct
identification
components
such
as
identification
code
and
password
a.
During
a
series
of
signings
over
a
continuous
period
of
controlled
system
access,
the
first
signing
uses
all
electronic
signature
components
while
each
subsequent
signature
uses
at
least
1
electronic
signature
component
that
is
only
executable
by
the
individual
2.
Be
used
by
the
genuine
owners
3.
Administered
and
executed
to
ensure
that
attempted
use
of
an
electronic
signature
by
anyone
other
than
its
genuine
owner
requires
the
collaboration
of
2
or
more
individuals
Electronic
Signatures
based
on
biometrics
-
answer-Designed
to
ensure
that
they
cannot
be
used
by
anyone
other
that
their
genuine
owners
Security
and
Integrity
of
identification
codes/passwords
-
answer-1.
Maintain
uniqueness
of
each
combined
ID
code
and
password
(No
2
people
have
same
combo)
2.
ID
code
and
password
are
periodically
checked,
recalled,
revised
(Prevent
PW
aging)
3.
Loss
management
procedures
to
deauthorize
lost,
stolen,
missing
or
otherwise
compromised
devices
that
generate
ID
code
or
PW
information
and
issue
replacements
4.
Use
of
safeguards
to
prevent
unauthorized
use
of
PWs
and/or
ID
codes
and
to
detect
and
report
any
attempts
at
their
unauthorized
use
5.
Initial
and
periodic
testing
of
devices
that
generate
ID
or
PW
information
to
ensure
they
function
properly
General
Requirements
for
informed
consent
-
answer-Must
obtain
legally
effective
informed
consent
Must
allow
for
sufficient
opportunity
to
consider
whether
or
not
to
participate
Minimize
possibility
of
coercion
or
undue
influence
Must
use
language
understandable
by
participant
Informed
consent
-
Language
may
not
-
answer-Language
may
not
include
exculpatory
language
in
which
the
subject
is
made
to
waive
or
appear
to
waive
their
legal
rights
or
releases
or
appears
to
release
the
investigator,
the
sponsor
or
its
agents
from
liability
or
negligence
Exception-
Obtaining
informed
consent
-
answer-Obtaining
informed
consent
is
deemed
feasible
unless
both
the
investigator
and
a
physician
who
is
not
not
participating
in
clinical
investigation
certify
in
writing
all
of
the
following:
1.
Subject
is
confronted
by
life-threatening
situation
necessitating
the
use
of
the
test
article 2.
Informed
consent
cannot
be
obtained
from
the
subject
because
of
an
inability
to
communicate
with,
or
obtain
legally
effective
consent
from,
the
subject
3.
Time
is
not
sufficient
to
obtain
consent
from
the
subject's
legal
representative
4.
There
is
now
alternative
method
available
or
approved
or
generally
recognized
therapy
that
provides
an
equal
or
greater
likelihood
of
saving
the
life
of
the
subject
Immediate
use
of
the
test
article
-
answer-If
immediate
use
is
required,
in
the
opinion
of
the
investigator,
to
preserve
the
life
of
the
subject
and
time
is
not
sufficient
to
obtain
independent
determination,
the
determination
of
the
investigator
shall
be
made
and,
within
5
working
days
of
the
use
of
the
article,
be
reviewed
and
evaluated
in
writing
by
a
physician
who
is
not
participating
in
the
clinical
investigation
Documentation
for
exception
in
obtaining
informed
consent
-
answer-Documentation
required
for
waiving
informed
consent
must
be
submitted
to
the
IRB
within
5
working
days
after
the
use
of
the
test
article
Waiver
of
consent
-
President
-
answer-The
president
may
waive
prior
consent
for
the
administration
of
an
investigational
new
drug
to
a
member
of
the
armed
forces
in
connection
with
the
member's
participation
in
a
particular
military
operation
The
president
must
determine
in
writing
that
obtaining
informed
consent
is
not
feasible,
is
contrary
to
the
best
interests
of
the
military
member,
or
is
not
in
the
interest
of
national
security
Waiving
informed
consent
for
investigation
in
vitro
diagnostic
devices
used
to
identify
chemical,
biological,
radiological
or
nuclear
agents
-
answer-Before
use
of
the
test
article,
the
investigatory
and
uninvolved
physician
must
certify
in
writing:
1.
Subject
is
in
life-threatening
situation
necessitating
the
use
of
the
product
to
identify
an
agent
that
would
suggest
a
terrorism
event
or
other
public
health
emergency
2.
Consent
cannot
be
obtained
because
the
person
collecting
the
specimen
could
not
know
there
would
be
a
need
to
use
the
product
on
that
specimen
and
time
is
not
sufficient
to
obtain
consent
without
risking
the
subject's
life
3.
Time
is
not
sufficient
to
obtain
consent
from
LAR
4.
No
available
alternative
method
of
diagnosis
Waiving
informed
consent
for
investigation
in
vitro
diagnostic
devices
used
to
identify
chemical,
biological,
radiological
or
nuclear
agents
-
answer-Before
use
of
the
test
article,
the
investigatory
and
uninvolved
physician
must
certify
in
writing:
1.
Subject
is
in
life-threatening
situation
necessitating
the
use
of
the
product
to
identify
an
agent
that
would
suggest
a
terrorism
event
or
other
public
health
emergency
2.
Consent
cannot
be
obtained
because
the
person
collecting
the
specimen
could
know
there
would
be
a
need
to
use
the
product
on
that
specimen
and
time
is
not
sufficient
to
botain
consent
without
risking
the
subject's
life
3.
Time
is
not
sufficient
to
obtain
consent
from
LAR
4.
No
available
alternative
method
of
diagnosis Waiving
informed
consent
for
use
of
in-vitro
diagnostic
device
and
not
sufficient
time
to
obtain
independent
determination
-
answer-Before
using
the
device,
the
investigator
must
make
the
determination
and
it
must
be
reviewed
within
5
working
days
by
uninvolved
physician
Waiving
informed
consent
for
in-vitro
diagnostic
device
-
answer-Determination
for
waiving
consent
must
be
submitted
to
the
IRB
for
review
within
5
working
days
Exception
from
informed
consent
for
emergency
research
-
answer-1.
Subject
is
in
life-threatening
situation,
available
treatments
are
unproved
or
unsatisfactory,
and
collection
of
scientific
evidence
is
necessary
to
determine
safety
and
effectiveness
of
intervention
2.
Consent
is
not
feasible
because
subject
cannot
consent
due
to
their
condition,
intervention
must
be
administered
before
consent
can
feasibly
be
attained,
no
reasonable
way
to
prospectively
ID
eligible
participants
3.
Participation
on
the
research
holds
the
prospect
of
a
direct
benefit
to
the
subject
4.
Clinical
investigation
could
not
be
carried
out
without
waiver
of
informed
consent
5.
Potential
therapeutic
window
is
defined
and
efforts
are
made
to
contact
LAR
and
obtain
consent
Waiving
informed
consent
for
emergency
research
-
Additional
protections
of
the
rights
and
welfare
of
subjects
-
answer-1.
Consultation
with
representative
of
the
communities
from
which
subjects
will
be
drawn
2.
Public
disclosure
to
the
communities
where
the
clinical
investigation
will
take
place
prior
to
study
and
include
risks
and
benefits.
Disclosure
will
also
take
place
following
conclusion
of
the
study
including
demographic
characteristics
and
resukts
3.
Establish
independent
data
monitoring
comittee
Elements
of
Informed
consent
-
General
requirements
-
answer-1.
A
statement
that
the
study
involves
research,
purpose
of
the
research,
expected
duration,
description
of
procedures,
ID
of
an
experimental
procedures
2.
Description
of
risks
or
discomforts
3.
Description
of
benefits
4.
Disclosure
of
alternative
procedures
or
courses
of
treatment
5.
Statement
describing
extent
to
which
confidentiality
will
be
maintained
and
notes
FDA
may
inspect
records
6.
For
research
involving
more
than
minimal
risk,
statement
explaining
whether
an
compensation
or
medical
treatments
are
available
if
injury
occurs
7.
Explanation
of
who
to
contact
for
answers
to
pertinent
questions
about
the
research
8.
Statement
that
participation
is
voluntary
and
refusal
to
participate
will
involve
no
penalty
Additional
elements
of
informed
consent
-
General
requriements,
when
appropriate
-
answer-1.
Statement
that
treatment
may
involve
risks
to
subject
which
are
currently
unforeseeable
2.
Circumstances
under
which
participation
may
be
terminsted
by
investigator
without
participant's
consent
3.
Additional
costs
to
subject
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