RAC-Drugs Only All Practice Final - Verified Multiple
Choice and Conceptual Actual Frequently Tested
Exam Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. 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 - ANSWER B. Conduct of nonclinical
laboratory studies
A. The regulation does not cover physical or chemical testing
B. 21 CFR 58.3(d) pertains to nonclinical laboratory testing to determine safety
C. Testing to determine utility is excluded
D. Basic exploratory studies are excluded
2. Consent from subjects for clinical study enrollment is a:
A. Proposed rule
B. Final rule
C. Recommendation
D. Guideline - ANSWER B. Final rule
,The FDA regulation on informed consent became a final rule on 27 January 1981
(21 CFR 50)
3. All of the following are requirements of an IRB, EXCEPT
A. Has at least 5 members
B. Includes at least 1 nonscientific member
C. Obtains informed consent from all subjects
D. Represents the cultural mix of the community - ANSWER C. Obtains
informed consent from all subjects
A. It is a requirement that each IRB have at least 5 members (21 CFR56.107(a)
B. The regulations require each IRB to have at least 1 member whose primary
concerns are in the scientific area and at least 1 whose primary concerns are in
nonscientific areas ((21 CFR56.107(c)
C. It is the responsibility of the clinical investigator to obtain consent from all
subjects, not the IRB (21 CFR 312.60)
D. The regulations require each IRB to have a diversity of members (race, gender,
cultural backgrounds ) (21 CFR56.107(a)
4. Financial Disclosure is required for investigators who, during the time the
clinical investigator is carrying out the study and for one year following the
completion of the study, have:
A. Been a prior employee of the sponsor company and own stock worth more
than $50,000 USD
,B. Been paid $15,000 USD for conducting clinical trials with the sponsor
C. A spouse who has been paid as a consultant by the company before the study
began
D. Is not a requirement for Phase 2 studies - ANSWER A. Been a prior
employee of the sponsor company and own stock worth more than $50,000 USD
6. Phase 2 clinical trials are being planned for a novel cancer drug. All the
following are appropriate factors in the phase of the study EXCEPT?
A. Enrollment of cancer patients
B. Enrollment of healthy subjects
C. Study of one or more indications
D. Collection of efficacy data - ANSWER C. Study of one or more indications
7. 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 - ANSWER A. Temporally associated with the use of the
investigational item but are not serious and/or unexpected
8. 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
B. Within 15 business days of receipt
C. Within 10 business days of receipt
D. With the next periodic adverse drug experience report - ANSWER A. Within
15 calendar days of receipt
9. 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 - ANSWER B. Test and control article
characterization
This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical
Laboratory Studies, not by quality system or GMP requirements. Note that
Laboratory controls for finished pharmaceuticals are required by 21CFR 211,
Subpart I.
10. 1 In order to ensure that a facility complies with GMP requirements, all of the
following features should be evaluated EXCEPT:
A. Air handling system
Choice and Conceptual Actual Frequently Tested
Exam Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. 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 - ANSWER B. Conduct of nonclinical
laboratory studies
A. The regulation does not cover physical or chemical testing
B. 21 CFR 58.3(d) pertains to nonclinical laboratory testing to determine safety
C. Testing to determine utility is excluded
D. Basic exploratory studies are excluded
2. Consent from subjects for clinical study enrollment is a:
A. Proposed rule
B. Final rule
C. Recommendation
D. Guideline - ANSWER B. Final rule
,The FDA regulation on informed consent became a final rule on 27 January 1981
(21 CFR 50)
3. All of the following are requirements of an IRB, EXCEPT
A. Has at least 5 members
B. Includes at least 1 nonscientific member
C. Obtains informed consent from all subjects
D. Represents the cultural mix of the community - ANSWER C. Obtains
informed consent from all subjects
A. It is a requirement that each IRB have at least 5 members (21 CFR56.107(a)
B. The regulations require each IRB to have at least 1 member whose primary
concerns are in the scientific area and at least 1 whose primary concerns are in
nonscientific areas ((21 CFR56.107(c)
C. It is the responsibility of the clinical investigator to obtain consent from all
subjects, not the IRB (21 CFR 312.60)
D. The regulations require each IRB to have a diversity of members (race, gender,
cultural backgrounds ) (21 CFR56.107(a)
4. Financial Disclosure is required for investigators who, during the time the
clinical investigator is carrying out the study and for one year following the
completion of the study, have:
A. Been a prior employee of the sponsor company and own stock worth more
than $50,000 USD
,B. Been paid $15,000 USD for conducting clinical trials with the sponsor
C. A spouse who has been paid as a consultant by the company before the study
began
D. Is not a requirement for Phase 2 studies - ANSWER A. Been a prior
employee of the sponsor company and own stock worth more than $50,000 USD
6. Phase 2 clinical trials are being planned for a novel cancer drug. All the
following are appropriate factors in the phase of the study EXCEPT?
A. Enrollment of cancer patients
B. Enrollment of healthy subjects
C. Study of one or more indications
D. Collection of efficacy data - ANSWER C. Study of one or more indications
7. 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 - ANSWER A. Temporally associated with the use of the
investigational item but are not serious and/or unexpected
8. 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
B. Within 15 business days of receipt
C. Within 10 business days of receipt
D. With the next periodic adverse drug experience report - ANSWER A. Within
15 calendar days of receipt
9. 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 - ANSWER B. Test and control article
characterization
This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical
Laboratory Studies, not by quality system or GMP requirements. Note that
Laboratory controls for finished pharmaceuticals are required by 21CFR 211,
Subpart I.
10. 1 In order to ensure that a facility complies with GMP requirements, all of the
following features should be evaluated EXCEPT:
A. Air handling system
