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US RAC Review Questions RAPS Modules
Question 1: In which situation is an IND not required?
a) You intend to conduct a clinical trial with an investigational
new drug
b) You intend to conduct a clinical trial with an approved drug
to support a marketing application for a new indication
c) You intend to collect blood samples from subjects to look for
biomarkers or pharmacogenetic information
d) You intend to conduct a clinical trial using 2 of your
approved drugs in a new combination
CORRECT ANSWER : c) You intend to collect blood samples
from subjects to look for biomarkers or pharmacogenetic information
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Question 2: In the clinical development plan for an
investigational antihypertensive drug, which of the following studies would typically be conducted first?
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- 1 month repeat dose toxicology study
b) Single dose escalation PK study in healthy volunteers
c) Multiple dose PK study in healthy volunteers
d) Single dose escalation study in hypertensive patients
CORRECT ANSWER : b) Single dose escalation PK study in
healthy volunteers
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Question 3: A sponsor must report an unexpected, fatal or life-
threatening experience believed to be associated with an
unapproved drug/biologic:
- to FDA, investigators and IRBs within 7 calendar days
- to FDA and investigators within 7 calendar days
- to FDA within 14 calendar days
- to FDA and investigators within 7 working days
CORRECT ANSWER : b) to FDA and investigators within 7
calendar days
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Question 4: Which of the following is a covered study as
defined under Financial Disclosure regulations?
a) Phase I dose escalation study
b) Phase I/II Pharmacokinetic Study
c) A large open label safety study conducted at a large number
of study sites
d) Phase III pivotal study
CORRECT ANSWER : d) Phase III pivotal study
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Question 5: Your company is developing a product to treat a
serious and life threatening disease. A clinically meaningful, well established primary endpoint will be used in the pivotal studies. Which regulatory strategy might you select prior to commencing Phase 3 studies?
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a) Request Special Protocol Assessment
b) Request Fast Track Designation
c) Request Priority Review
d) Approval under Subpart H, Accelerated Approval of New
Drugs for Serious or Life Threatening Illnesses
CORRECT ANSWER : a) Request Special Protocol Assessment
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Question 6: As a regulatory affairs professional, you are
responsible for developing the content of an information package for a Type B meeting with FDA. Your primary
objective is to:
a) Reach consensus on content from contributing team members
b) Ensure content is sufficient to support meeting objective(s)
and questions to FDA