US RAC EXAM 2026 SCRIPT
COMPREHENSIVE ANSWERS VERIFIED
EXCELLENCE
◉ 18) With respect to a Non-Significant Risk device clinical trial,
which of the following is NOT required before starting the trial?
A) Informed consent of trial participants
B) IRB approval of the trial
C) Financial disclosure by investigators
D) Submission of the trial protocol to FDA for approval
Answer: D) Submission of the trial protocol to FDA for approval
◉ 19) The establishment, performance and auditing of a human-use
clinical device trial requires conformance with all of the following
except:
A) 21 CFR 50 Protection of Human Subjects
B) 21 CFR 56 IRB
C) 21 CFR 807 Establishment Registration
D) 21 CFR 812 IDE Exemptions
Answer: C) 21 CFR 807 Establishment Registration
,◉ 20) According to the Federal Food, Drug and Cosmetics (FD&C)
Act, a drug is defined as all of the following except:
A. Recognized in the US Pharmacopoeia , Homeopathic
Pharmacopoeia of the United States, or the National Formulary
B. Devices or their components
C. Intended for diagnosis, cure, mitigation, treatment or prevent of
disease in humans or other animals
D. Intended to affect the structure or any function for the body of
humans or other animals
Answer: B. Devices or their components
◉ 21) It is acceptable for FDA forms completed and submitted by
the principal investigator to support an IND submission to include
the which of following:
A. Typed name in the signature block
B. Rubber stamped name in the signature block
C. Handwritten dates
D. Signature of study staff personnel on behalf of the investigator
Answer: C. Handwritten dates
,Good documentation practice dictates that signatures
not be stamped, or typed in order to be legitimate and
controlled. Signatures must be written by the individual
who is responsible for the activity indicated and cannot
be delegated.
◉ 22) Who has final authority over content of an Informed Consent?
A. FDA
B. Sponsor
C. Investigator
D. IRB
Answer: D. IRB
◉ 23) The following are characteristics of FDA GMP inspections
except:
A. Results of internal audit findings are required to be provided to
the FDA Inspectors upon request
B. Biennial inspections of manufacturing facilities take place to
verify compliance with regulations.
C. The FDA may inspect the drug product sponsor and any
manufacturing subcontractors.
, D. FDA inspections may be conducted due to serious non-compliance
with GMP regulations
Answer: A. Results of internal audit findings are required to be
provided to the FDA Inspectors upon request
◉ 24) Management should be notified in writing of the GMP
Investigations conducted for all of the following except:
A. Product Complaints
B. Batch Production Record documentation corrections
C. Returned Drug Products
D. Drug Product Salvaging
Answer: B. Batch Production Record documentation corrections
◉ 25) According to GMP regulations, the quality control unit is
responsible for which of the following activities:
A. Issuing unique identification to all major manufacturing
equipment
B. Manufacturing drug products
C. Warehousing and distributing drug products
D. Approving and rejecting raw materials, components, label, drug
products, procedures and specifications
COMPREHENSIVE ANSWERS VERIFIED
EXCELLENCE
◉ 18) With respect to a Non-Significant Risk device clinical trial,
which of the following is NOT required before starting the trial?
A) Informed consent of trial participants
B) IRB approval of the trial
C) Financial disclosure by investigators
D) Submission of the trial protocol to FDA for approval
Answer: D) Submission of the trial protocol to FDA for approval
◉ 19) The establishment, performance and auditing of a human-use
clinical device trial requires conformance with all of the following
except:
A) 21 CFR 50 Protection of Human Subjects
B) 21 CFR 56 IRB
C) 21 CFR 807 Establishment Registration
D) 21 CFR 812 IDE Exemptions
Answer: C) 21 CFR 807 Establishment Registration
,◉ 20) According to the Federal Food, Drug and Cosmetics (FD&C)
Act, a drug is defined as all of the following except:
A. Recognized in the US Pharmacopoeia , Homeopathic
Pharmacopoeia of the United States, or the National Formulary
B. Devices or their components
C. Intended for diagnosis, cure, mitigation, treatment or prevent of
disease in humans or other animals
D. Intended to affect the structure or any function for the body of
humans or other animals
Answer: B. Devices or their components
◉ 21) It is acceptable for FDA forms completed and submitted by
the principal investigator to support an IND submission to include
the which of following:
A. Typed name in the signature block
B. Rubber stamped name in the signature block
C. Handwritten dates
D. Signature of study staff personnel on behalf of the investigator
Answer: C. Handwritten dates
,Good documentation practice dictates that signatures
not be stamped, or typed in order to be legitimate and
controlled. Signatures must be written by the individual
who is responsible for the activity indicated and cannot
be delegated.
◉ 22) Who has final authority over content of an Informed Consent?
A. FDA
B. Sponsor
C. Investigator
D. IRB
Answer: D. IRB
◉ 23) The following are characteristics of FDA GMP inspections
except:
A. Results of internal audit findings are required to be provided to
the FDA Inspectors upon request
B. Biennial inspections of manufacturing facilities take place to
verify compliance with regulations.
C. The FDA may inspect the drug product sponsor and any
manufacturing subcontractors.
, D. FDA inspections may be conducted due to serious non-compliance
with GMP regulations
Answer: A. Results of internal audit findings are required to be
provided to the FDA Inspectors upon request
◉ 24) Management should be notified in writing of the GMP
Investigations conducted for all of the following except:
A. Product Complaints
B. Batch Production Record documentation corrections
C. Returned Drug Products
D. Drug Product Salvaging
Answer: B. Batch Production Record documentation corrections
◉ 25) According to GMP regulations, the quality control unit is
responsible for which of the following activities:
A. Issuing unique identification to all major manufacturing
equipment
B. Manufacturing drug products
C. Warehousing and distributing drug products
D. Approving and rejecting raw materials, components, label, drug
products, procedures and specifications
