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US RAC Review Questions RAPS Modules Exam Questions and Answers
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US RAC Review Questions RAPS ModulesExam Questions and Answers
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
In the clinical development plan for an investigational
antihypertensive drug, which of the following studies would
typically be conducted first:
A) 1 month repeat dose toxicology study
B) Single dose escalation PK study in healthy volunteers
C) Multiple dose PK study in healthy volunteers
,US RAC Review Questions RAPS Modules
Exam Questions and Answers
D) Single dose escalation study in hypertensive patients -
Correct Answer ✅ B) Single dose escalation PK study in
healthy volunteers
A sponsor must report an unexpected, fatal or life-threatening
experience believed to be associated with an unapproved
drug/biologic:
A) to FDA, investigators and IRBs within 7 calendar days
B) to FDA and investigators within 7 calendar days
C) to FDA within 14 calendar days
D) to FDA and investigators within 7 working days - Correct
Answer ✅ B) to FDA and investigators within 7 calendar
days
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
,US RAC Review Questions RAPS Modules
Exam Questions and Answers
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
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?
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
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:
, US RAC Review Questions RAPS Modules
Exam Questions and Answers
A) Reach consensus on content from contributing team
members
B) Ensure content is sufficient to support meeting objective(s)
and questions to FDA
C) Provide appropriate preclinical summary
D) Provide appropriate clinical summary - Correct Answer
✅ B) Ensure content is sufficient to support meeting
objective(s) and questions to FDA
You, a regulatory affairs professional, are assessing the
information to be submitted in support of a marketing
application for a new dosage form for a listed drug. You lack
right of reference to one key preclinical report. Which type of
application will you prepare for submission?
A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
D) PMA - Correct Answer ✅ B) 505 (b) (2)
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