RAC FINAL PAPER 2026 FULL QUESTIONS
AND CORRECT ANSWERS
◉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). Answer:
False: Advisory commitee 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). Answer: True
◉Where can you find guidance on the time frames for preparing
briefing materials for an advisory committee meeting?(5:3). Answer:
"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).
Answer: 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). Answer:
Industry members are non-voting members of an advisory
committee. (21 CFR 14.84)
◉Stability testing of clincial 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). Answer: C: Good Manufacturing Practice
Regulations
◉True or False: Good Laboratory Practice Regulations require the
Quality Assurance Unit to prepare a GLP Complaince Statement for
inclusion in the final study report(6:2).. Answer: True
◉True or False: The Quality Assurance Unit must review and
approve all standard operating procedures applicable to a
nonclinical test laboratory.(6:3). Answer: 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). Answer: 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). Answer: C: Study Director
, ◉What is one difference between a device trial and a drug
trial?(7:1). Answer: Form FDA 1572 is required for a drug clinical
trial but not a device
◉List three regulations that are applicable to both drug and device
clinical trials?(7:2). Answer: 21 CFR Parts 50, 54 and 56
◉List at least two criteria that distinguish the Privacy Rule from the
Common Rule?(7:3). Answer: 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 authory 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). Answer: Devices
◉Does the clinical trial database apply to drugs or devices? (8:2).
Answer: Drugs
◉The IRB regulations codified in 21 CFR Part 50 apply only to drugs.
True or False?(8:3). Answer: False. the regulations apply to both
AND CORRECT ANSWERS
◉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). Answer:
False: Advisory commitee 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). Answer: True
◉Where can you find guidance on the time frames for preparing
briefing materials for an advisory committee meeting?(5:3). Answer:
"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).
Answer: 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). Answer:
Industry members are non-voting members of an advisory
committee. (21 CFR 14.84)
◉Stability testing of clincial 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). Answer: C: Good Manufacturing Practice
Regulations
◉True or False: Good Laboratory Practice Regulations require the
Quality Assurance Unit to prepare a GLP Complaince Statement for
inclusion in the final study report(6:2).. Answer: True
◉True or False: The Quality Assurance Unit must review and
approve all standard operating procedures applicable to a
nonclinical test laboratory.(6:3). Answer: 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). Answer: 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). Answer: C: Study Director
, ◉What is one difference between a device trial and a drug
trial?(7:1). Answer: Form FDA 1572 is required for a drug clinical
trial but not a device
◉List three regulations that are applicable to both drug and device
clinical trials?(7:2). Answer: 21 CFR Parts 50, 54 and 56
◉List at least two criteria that distinguish the Privacy Rule from the
Common Rule?(7:3). Answer: 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 authory 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). Answer: Devices
◉Does the clinical trial database apply to drugs or devices? (8:2).
Answer: Drugs
◉The IRB regulations codified in 21 CFR Part 50 apply only to drugs.
True or False?(8:3). Answer: False. the regulations apply to both
