US RAC Review Questions RAPS Modules

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US RAC Review Questions RAPS Modules

Question 1: In which situation is an IND not required?

• You intend to conduct a clinical trial with an investigational

new drug

• You intend to conduct a clinical trial with an approved drug

to support a marketing application for a new indication

• You intend to collect blood samples from subjects to look for

biomarkers or pharmacogenetic information

• 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:

• 1 month repeat dose toxicology study
• Single dose escalation PK study in healthy volunteers

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• Multiple dose PK study in healthy volunteers
• 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:

• Phase I dose escalation study
• Phase I/II Pharmacokinetic Study
• A large open label safety study conducted at a large number

of study sites

• 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?

• Request Special Protocol Assessment
• Request Fast Track Designation
• Request Priority Review

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• 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:

• Reach consensus on content from contributing team

members

• Ensure content is sufficient to support meeting objective(s)

and questions to FDA

• Provide appropriate preclinical summary
• Provide appropriate clinical summary

CORRECT ANSWER : B) Ensure content is sufficient to

support meeting objective(s) and questions to FDA