Page 1 of 412
RAC-DRUGS FINAL EXAM TEST BANK LATEST VERSION
WITH ALL 650 QUESTIONS AND CORRECT DETAILED
SOLUTIONS RELEASED THIS YEAR
Question: Sponsors of a clinical trial must immediately notify FDA and investigators of SAEs
EXCEPT?
A. Temporally associated with the use of the investigational item but are not serious and/or
unexpected
B. Described in the IB but with greater severity
C. Life-threatening or result in inpatient hospitalization
D. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to
the drug - CORRECT ANSWER✔✔A. Temporally associated with the use of the investigational
item but are not serious and/or unexpected
Question: From a subsidiary in Ireland, you are forwarded a report that a patient taking your
drug was hospitalized with a case of Stevens-Johnson syndrome. This hypersensitivity reaction is
not listed on your label. You should report this case to FDA:
A. Within 15 calendar days of receipt
, Page 2 of 412
B. Within 15 business days of receipt
C. Within 10 business days of receipt
D. With the next periodic adverse drug experience report - CORRECT ANSWER✔✔A. Within 15
calendar days of receipt
Question: Which of the following subsystems is NOT required by FDA in order to implement
and maintain a Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls - CORRECT ANSWER✔✔B. Test and control article
characterization
Question: What is the mission of the FDA?
A. Promote public health
B. Protect public health
C. Pursue international harmonization
D. All of the above - CORRECT ANSWER✔✔D. All of the above
, Page 3 of 412
Question: The Freedom of Information Act prohibits FDA from preventing the release of FDA-
generated records:
True or False - CORRECT ANSWER✔✔FALSE
Question: Veterinary drugs are regulated under the Center for Drug Evaluation and Research
(CDER), because the requirements for approval are the same:
True or False - CORRECT ANSWER✔✔FALSE
Question: In order of highest level to lowest level, the ranking at US governmental
organizations is:
A. Division, Office, Center, Agency, Department
B. Department, Agency, Center, Office, Division
C. Center, Department, Division, Agency, Office
D. Agency, Center, Office, Department, Division - CORRECT ANSWER✔✔B. Department, Agency,
Center, Office, Division
Question: For nonclinical studies lasting more than 6 months, quality assurance audits are
conducted at which of the following intervals?
, Page 4 of 412
A. 1 month
B. quarterly
C. at completion
D. periodically - CORRECT ANSWER✔✔D. periodically
Audits should be conducted at intervals appropriate to assure the integrity of the study (rules
out answers A,B and C).
Periodic auditing by the quality assurance unit is required as appropriate for the study
(21CFR58.35(b)(3)
Question: Good Laboratory Practices Regulations govern the:
A. Conduct and control of laboratory activities
B. Conduct of nonclinical laboratory studies
C. Determination of product efficacy in animals
D. Determination of product feasibility - CORRECT ANSWER✔✔B. Conduct of nonclinical
laboratory studies
Question: According to the Quality System Regulation, when an investigation of a complaint is
conducted all of the following are requirements for inclusion in the record of the investigation
EXCEPT:
RAC-DRUGS FINAL EXAM TEST BANK LATEST VERSION
WITH ALL 650 QUESTIONS AND CORRECT DETAILED
SOLUTIONS RELEASED THIS YEAR
Question: Sponsors of a clinical trial must immediately notify FDA and investigators of SAEs
EXCEPT?
A. Temporally associated with the use of the investigational item but are not serious and/or
unexpected
B. Described in the IB but with greater severity
C. Life-threatening or result in inpatient hospitalization
D. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to
the drug - CORRECT ANSWER✔✔A. Temporally associated with the use of the investigational
item but are not serious and/or unexpected
Question: From a subsidiary in Ireland, you are forwarded a report that a patient taking your
drug was hospitalized with a case of Stevens-Johnson syndrome. This hypersensitivity reaction is
not listed on your label. You should report this case to FDA:
A. Within 15 calendar days of receipt
, Page 2 of 412
B. Within 15 business days of receipt
C. Within 10 business days of receipt
D. With the next periodic adverse drug experience report - CORRECT ANSWER✔✔A. Within 15
calendar days of receipt
Question: Which of the following subsystems is NOT required by FDA in order to implement
and maintain a Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls - CORRECT ANSWER✔✔B. Test and control article
characterization
Question: What is the mission of the FDA?
A. Promote public health
B. Protect public health
C. Pursue international harmonization
D. All of the above - CORRECT ANSWER✔✔D. All of the above
, Page 3 of 412
Question: The Freedom of Information Act prohibits FDA from preventing the release of FDA-
generated records:
True or False - CORRECT ANSWER✔✔FALSE
Question: Veterinary drugs are regulated under the Center for Drug Evaluation and Research
(CDER), because the requirements for approval are the same:
True or False - CORRECT ANSWER✔✔FALSE
Question: In order of highest level to lowest level, the ranking at US governmental
organizations is:
A. Division, Office, Center, Agency, Department
B. Department, Agency, Center, Office, Division
C. Center, Department, Division, Agency, Office
D. Agency, Center, Office, Department, Division - CORRECT ANSWER✔✔B. Department, Agency,
Center, Office, Division
Question: For nonclinical studies lasting more than 6 months, quality assurance audits are
conducted at which of the following intervals?
, Page 4 of 412
A. 1 month
B. quarterly
C. at completion
D. periodically - CORRECT ANSWER✔✔D. periodically
Audits should be conducted at intervals appropriate to assure the integrity of the study (rules
out answers A,B and C).
Periodic auditing by the quality assurance unit is required as appropriate for the study
(21CFR58.35(b)(3)
Question: Good Laboratory Practices Regulations govern the:
A. Conduct and control of laboratory activities
B. Conduct of nonclinical laboratory studies
C. Determination of product efficacy in animals
D. Determination of product feasibility - CORRECT ANSWER✔✔B. Conduct of nonclinical
laboratory studies
Question: According to the Quality System Regulation, when an investigation of a complaint is
conducted all of the following are requirements for inclusion in the record of the investigation
EXCEPT:
