SOCRA Certification Exam Questions And Answers
Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - ANS Yes (although permission to use such e-cigs has to be approved by the FDA)
Does the FDA consider electronic records that meet r...
SOCRA
Certification
Exam
Does
the
FDA
consider
electronic
signatures
to
be
as
trustworthy
and
reliable
as
handwritten
paper
signatures?
-
ANS
Yes
(although
permission
to
use
such
e-cigs
has
to
be
approved
by
the
FDA)
Does
the
FDA
consider
electronic
records
that
meet
requirements
to
be
equivalent
to
handwritten
records
?
-
ANS
Yes
Open
system
(FDA
term)
-
ANS
System
access
is
NOT
controlled
by
people
who
are
responsible
for
the
content
of
the
electronic
records
in
the
system.
(Like
me
putting
data
into
CHOP
-
controlled
databases)
Closed
system
(FDA
term)
-
ANS
Environment
in
which
SYSTEM
ACCESS
is
controlled
by
the
same
people
responsible
for
the
content
of
the
system
(I.E.
I
control
the
Robotic
Database
access
AND
its
contents)
What
are
some
FDA
Standards
to
meet
when
operating
a
closed
record
system?
-
ANS
1.
Must
be
able
to
tell
if
records
have
been
altered
or
invalid
2.
Must
be
able
to
copy
records
for
agency
review
3.
Protect
records
throughout
retention
period
4.
Limit
system
to
authorized
individuals
only
5.
Use
time-stamped
audit
trails
of
modification
etc
6.
Use
operational
system
checks
and
restrictions
7.
Use
authority
checks
to
make
sure
only
authorized
individuals
are
using
the
system
8.
Use
device
checks
to
validate
data
input
9.
Make
sure
those
authorized
to
use
system
have
appropriate
training,
education,
experience
10.
Have
written
policies
that
deter
data
falsification
11.
Audit
and
control
the
maintenance
of
the
actual
system
What
are
some
FDA
standards
to
meet
when
using
an
Open
System?
-
ANS
All
those
mentioned
for
the
closed
system.
1.
Document
encryption
as
appropriate
What
information
should
a
handwritten
SIGNATURE
block
contain?
-
ANS
1.
Printed
name
of
signer
2.
Date
and
Time
when
signature
was
executed
3.
The
MEANING
associated
with
the
signature
(approval?
responsibility?
authorship?)
Signature
and
record
linking
?
-
ANS
Signatures
must
be
linked
to
their
respective
electronic
records
to
make
sure
they
cannot
be
copied,
falsified,
transferred
etc. Do
researchers
need
to
request
permission
from
the
FDA
to
use
electronic
signatures
in
place
of
regular
signatures?
-
ANS
Yes
What
controls
should
an
E-SIGNATURE
contain?
-
ANS
Employ
at
least
2
identification
components
-
such
as
an
identification
code
AND
a
password.
Name
some
CONTROLS
for
the
identification
components
(i.e.
identification
code
and
password)
for
e-signature?
-
ANS
1.
no
2
people
should
have
the
same
identification
controls
(password...
code)
2.
Identification
codes
and
passwords
should
be
periodically
checked,
revised,
etc.
3.
Deauthorize
lost,
stolen,
missing
codes
and
passwords
4.
Periodically
test
your
devices
that
generate
these
codes
Can
an
informed
consent
contain
exculpatory
language?
-
ANS
NO!
Cannot
say
things
like
"you
are
waiving
your
right
to
damages"
etc
When
may
an
experimental
drug
or
device
be
used
on
a
patient
WITHOUT
informed
consent?
((EMERGENCY
USE))
-
ANS
1.
the
investigator
and
an
independent
physician
agree
that
the
patient
is
-life
threatening
situation
-informed
consent
cannot
be
obtained
-
there
is
no
time
to
obtain
consent
from
th
esubject's
legal
representation
-there
is
no
recognized
therapy
that
provides
equal
or
greater
likelihood
of
saving
life
-
within
5
working
days
this
must
be
evaluated
by
another
independent
physician
-documentation
must
be
submitted
to
the
IRB
within
5
working
days
-the
president
can
authorize
use
on
the
military
(lots
of
information
on
this
military
stuff..)
When
is
it
okay
to
skip
informed
consent
and
perform
((EMERGENCY
RESEARCH))?
-
ANS
1.
Human
subjects
are
in
life
threatening
danger,
available
treatments
are
unproven
or
unsatisfactory,
and
collection
of
valid
science
is
needed
2.
Obtaining
consent
is
not
feasible
-subjects
can't
consent
due
to
medical
state
-can't
feasibly
get
LAR
consent
in
time
-no
reasonable
way
to
identify
ahead
of
time
individuals
who
will
be
eligible
for
participation
3.
Participation
holds
the
prospect
of
direct
benefit
to
subjects
-animal/preclinical
studies
support
it
-risks
are
reasonable
4.
could
not
practicably
be
carried
out
without
waiver
of
consent
5.
OTHER
protective
measures
are
in
place
(counseling,
disclosure,
disclosure
to
public,
data
monitoring
committee
ETC
Name
the
8
elements
of
INFORMED
CONSENT
-
ANS
1.
statement
of
research.
purpose
of
research.
duration
of
participation.
procedures
involved.
identification
of
all
that
is
experimental.
2.
Risks
and
discomforts
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