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RAC EXAM PRACTICE QUESTIONS AND ANSWERS
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RAC EXAM PRACTICE QUESTIONS AND ANSWERS
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RAC EXAM PRACTICE QUESTIONS AND ANSWERSWhich of the following was NOT a requirement of the original Food Drug and Cosmetic
Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d)
Safe tolerances for unavoidable poisonous substances(1:1) - Answers -A: Proof of
efficacy
Which amendments to the FD&C Act resulted from the thalidomide tragedy? a)
Durham-Humphrey Amendments b) Hatch-Waxman Act c) Controlled Substances Act
d) Kefauver-Harris Amendments (1:2) - Answers -D: Kefauver-Harris Amendments
The Color Additive Amendment of 1960 required FDA to prove that a color additive was
unsafe before removing it from the market. a) True b) False(1:3) - Answers -B: False
What has been described as "the most extensive change to the agency's practices
since 1938?" a) Prescription Drug User Fee Act of 1922b) GMPs for the 21st Century
initiative c) Food and Drug Administration Modernization Act d) Food and Drug
Administration Amendments Act(1:4) - Answers -C: Food and Drug Administration
Modernization Act
True or False: FDA advisory committee meetings may be completely closed to the
public and notice of a meeting is not required to be published until the day of the
meeting. (5:1) - Answers -False: Advisory committee meetings may be closed but no
advisory committee meeting can be completely closed (21 CFR 14.27)
True or False: FDA advisory committees provide independent expert advice and
credibility to product reviews. (5:2) - Answers -True
Where can you find guidance on the time frames for preparing briefing materials for an
advisory committee meeting?(5:3) - Answers -"Guidance for Industry Advisory
Committee Meetings - Preparation and Public Availability of Information Given to
Advisory Committee Members (August 2008)"
True or False: There are 31 advisory committees within FDA.(5:4) - Answers -True
Industry representatives are/are not voting members of an advisory committee because
they are independent of the sponsor company and represent the industry as a whole.
(5:5) - Answers -Industry members are non-voting members of an advisory committee.
(21 CFR 14.84)
Stability testing of clinical trial materials and commercial drug products is subject to: a)
Good Laboratory Practice Regulations b) Good Scientific Practice Regulations c) Good
Manufacturing Practice Regulations d) Both a and b e) None f) All of the above(6:1) -
Answers -C: Good Manufacturing Practice Regulations
, True or False: Good Laboratory Practice Regulations require the Quality Assurance Unit
to prepare a GLP Compliance Statement for inclusion in the final study report(6:2). -
Answers -True
True or False: The Quality Assurance Unit must review and approve all standard
operating procedures applicable to a nonclinical test laboratory.(6:3) - Answers -False
Test systems for nonclinical laboratory studies may include: a) Rodents b) Primates c)
Humans d) Canines e) Bacteria f) All of the above g) a b and c h) a b d and e(6:4) -
Answers -H: a-Rodents b-Primates d-Canines and e-Bacteria
Corrections to the signed and dated final study report may be made in the form of a
report amendment by the: a) Quality Assurance Unit b) Test Facility Management c)
Study Directory d) Any of the above e) None of the above(6:5) - Answers -C: Study
Director
What is one difference between a device trial and a drug trial?(7:1) - Answers -Form
FDA 1572 is required for a drug clinical trial but not a device
clinical trial. - Answers -
List three regulations that are applicable to both drug and device clinical trials?(7:2) -
Answers -21 CFR Parts 50 54 and 56
List at least two criteria that distinguish the Privacy Rule from the Common Rule?(7:3) -
Answers -The Privacy Rule applies to a covered entity's use or disclosure of PHI for any
research purposes regardless of funding or what agency has regulatory authority over
the research. Under the Common Rule the scope of the FDA Protection of Human
Subject Regulations applies only to research over which FDA has jurisdiction primarily
research involving investigational products.
Does the Quality System Regulation apply to drugs or devices?(8:1) - Answers -Devices
Does the clinical trial database apply to drugs or devices? (8:2) - Answers -Drugs
The IRB regulations codified in 21 CFR Part 50 apply only to drugs. True or False?(8:3)
- Answers -False. the regulations apply to both
Name at least three states that have neither clinical trial legislation nor clinical trial
insurance legislation.(8:4) - Answers -AL AK AR HI ID IA KS and MS
What is GMP?(9:1) - Answers -Good Manufacturing Practice or GMP is a term that is
recognized worldwide for the control and management of manufacturing and quality
control testing of foods pharmaceutical products and medical devices. Drug GMPs are a
set of regulations that establish minimum requirements for the methods facilities and
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