RAC PRACTICE EXAM 1 / ACTUAL
TEST QUESTIONS WITH DETAILED
VERIFIED ANSWERS / ALREADY
GRADED A+
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Terms in this set (93)
,Which of the A.
following is NOT
required for
compliance under
21 CFR Part 11
(electronic records
and electronic
signatures)?
A Manually
generated
timestamped audit
trails to record the
date and time of
operator entries
and actions that
create, modify or
delete electronic
records.
B Validation of
systems to ensure
accuracy
C Authority checks
to ensure that only
authorized
personell can
create, modify or
delete electronic
records.
,D Establishment of
and adherence to
written
procedures
The final authority Institutional Review Board (IRB)
for ensuring the
adequacy of an
Investigational
New Drug (IND)
informed consent
document resides
with the:
, A sponsor wishes Suitability Petition
to obtain
permission from
FDA to submit an
ANDA for a drug
product that varies
from the
Reference Listed
Drug (RLD) in
route of
administration,
dosage form, or
strength, but
anticipates that the
labeling will be
identical to that of
the RLD. What
process should be
used to apply for
that permission
from FDA?
A 505(b)(2) NDA is New chemical entity when the sponsor
not an appropriate has a right of reference to all applicable
regulatory published studies
submission for the
approval to market
a
TEST QUESTIONS WITH DETAILED
VERIFIED ANSWERS / ALREADY
GRADED A+
Save
Terms in this set (93)
,Which of the A.
following is NOT
required for
compliance under
21 CFR Part 11
(electronic records
and electronic
signatures)?
A Manually
generated
timestamped audit
trails to record the
date and time of
operator entries
and actions that
create, modify or
delete electronic
records.
B Validation of
systems to ensure
accuracy
C Authority checks
to ensure that only
authorized
personell can
create, modify or
delete electronic
records.
,D Establishment of
and adherence to
written
procedures
The final authority Institutional Review Board (IRB)
for ensuring the
adequacy of an
Investigational
New Drug (IND)
informed consent
document resides
with the:
, A sponsor wishes Suitability Petition
to obtain
permission from
FDA to submit an
ANDA for a drug
product that varies
from the
Reference Listed
Drug (RLD) in
route of
administration,
dosage form, or
strength, but
anticipates that the
labeling will be
identical to that of
the RLD. What
process should be
used to apply for
that permission
from FDA?
A 505(b)(2) NDA is New chemical entity when the sponsor
not an appropriate has a right of reference to all applicable
regulatory published studies
submission for the
approval to market
a
