RAC-DRUGS ONLY ALL PRACTICE
EXAM FINAL WITH ALL GRADED A+
SOLUTIONS
According tto tthe tQuality tSystem tRegulation, twhen tan tinvestigation tof ta tcomplaint tis
tconducted tall tof tthe tfollowing tare trequirements tfor tinclusion tin tthe trecord tof tthe
tinvestigation tEXCEPT:
A. tThe tdates tand tresults tof tthe tinvestigation
B. tThe tnature tand tdetails tof tthe tcomplaint
C. tChanges tin tprocedures tcorrecting tquality tproblems
D. tAny treply tto tthe tcomplainant t- tcorrect tanswers t-C.
A tregulatory taffairs tprofessional twants tto tschedule ta tpre-NDA tmeeting twith tFDA.
tHe tor tshe tshould:
,A. tWrite ta tletter tto tFDA trequesting ta tType tA tmeeting tas tan tamendment tto tthe tIND
B. tRequest ta tType tB tmeeting tas tan tamendment tto tthe tIND
C. tCall tthe tproject tmanager tand tset tup ta tdate tover tthe tphone tfor ta tType tC
tmeeting
D. tEmail tthe tdivision tdirector twith ta tlist tof tthree tdates, t30 tdays tinto tthe tfuture t-
tcorrect tanswers t-B.
Following tthe t"elixir tof tSulfanilamide" ttragedy, tpublic toutcry tled tto tthe t1938 tpassage
tof t
A. tThe tPure tFood tand tDrug tAct
B. tThe tFederal tFood tDrug tand tCosmetic tAct
C. tThe tKefauver-Harris tDrug tAmendments
D. tThe tPublic tHealth tService tAct t- tcorrect tanswers t-B. tThe tFederal tFood tDrug tand
tCosmetic tAct
What tproducts tare texempt tfrom tthe tPrescription tDrug tUser tFees tAct t(PDUFA)? t
A. tGeneric tdrugs tonly
B. tOrphan tdrugs tand tcosmetics tonly
C. tOTC tdrugs, tcosmetics, tgeneric tdrugs tand tmedical tdevices
D. tPrescription tdrugs tmarketed tbefore t1992 t- tcorrect tanswers t-C. tOTC tdrugs,
tcosmetics, tgeneric tdrugs tand tmedical tdevices
Which tis tnot ta tdivision tof tthe tFDA?
A. tCDRH
B. tCDER
C. tCFER
D. tCVM t- tcorrect tanswers t-C. tCFER
What tis tthe tmission tof tthe tFDA?
A. tPromote tpublic thealth t
B. tProtect tpublic thealth t
C. tPursue tinternational tharmonization t
D. tAll tof tthe tabove t- tcorrect tanswers t-D. tAll tof tthe tabove
The tFreedom tof tInformation tAct tprohibits tFDA tfrom tpreventing tthe trelease tof tFDA-
generated trecords:
tTrue tor tFalse t- tcorrect tanswers t-FALSE
Veterinary tdrugs tare tregulated tunder tthe tCenter tfor tDrug tEvaluation tand tResearch
t(CDER), tbecause tthe trequirements tfor tapproval tare tthe tsame:
tTrue tor tFalse t- tcorrect tanswers t-FALSE
,In torder tof thighest tlevel tto tlowest tlevel, tthe tranking tat tUS tgovernmental
torganizations tis:
A. tDivision, tOffice, tCenter, tAgency, tDepartment
B. tDepartment, tAgency, tCenter, tOffice, tDivision
C. tCenter, tDepartment, tDivision, tAgency, tOffice
D. tAgency, tCenter, tOffice, tDepartment, tDivision t- tcorrect tanswers t-B. tDepartment,
tAgency, tCenter, tOffice, tDivision
For tnonclinical tstudies tlasting tmore tthan t6 tmonths, tquality tassurance taudits tare
tconducted tat twhich tof tthe tfollowing tintervals?
A. t1 tmonth
B. tquarterly
C. tat tcompletion
D. tperiodically t- tcorrect tanswers t-D. tperiodically
Audits tshould tbe tconducted tat tintervals tappropriate tto tassure tthe tintegrity tof tthe
tstudy t(rules tout tanswers tA,B tand tC). t
Periodic tauditing tby tthe tquality tassurance tunit tis trequired tas tappropriate tfor tthe
tstudy t(21CFR58.35(b)(3)
Good tLaboratory tPractices tRegulations tgovern tthe:
A. tConduct tand tcontrol tof tlaboratory tactivities
B. tConduct tof tnonclinical tlaboratory tstudies
C. tDetermination tof tproduct tefficacy tin tanimals
D. tDetermination tof tproduct tfeasibility t- tcorrect tanswers t-B. tConduct tof tnonclinical
tlaboratory tstudies
A. tThe tregulation tdoes tnot tcover tphysical tor tchemical ttesting
B. t21 tCFR t58.3(d) tpertains tto tnonclinical tlaboratory ttesting tto tdetermine tsafety
C. tTesting tto tdetermine tutility tis texcluded
D. tBasic texploratory tstudies tare texcluded
Consent tfrom tsubjects tfor tclinical tstudy tenrollment tis ta:
A. tProposed trule
B. tFinal trule
C. tRecommendation t
D. tGuideline t- tcorrect tanswers t-B. tFinal trule
The tFDA tregulation ton tinformed tconsent tbecame ta tfinal trule ton t27 tJanuary t1981
t(21 tCFR t50)
All tof tthe tfollowing tare trequirements tof tan tIRB, tEXCEPT
, A. tHas tat tleast t5 tmembers
B. tIncludes tat tleast t1 tnonscientific tmember
C. tObtains tinformed tconsent tfrom tall tsubjects
D. tRepresents tthe tcultural tmix tof tthe tcommunity t- tcorrect tanswers t-C. tObtains
tinformed tconsent tfrom tall tsubjects
A. tIt tis ta trequirement tthat teach tIRB thave tat tleast t5 tmembers t(21 tCFR56.107(a)
B. tThe tregulations trequire teach tIRB tto thave tat tleast t1 tmember twhose tprimary
tconcerns tare tin tthe tscientific tarea tand tat tleast t1 twhose tprimary tconcerns tare tin
tnonscientific tareas t((21 tCFR56.107(c)
C. tIt tis tthe tresponsibility tof tthe tclinical tinvestigator tto tobtain tconsent tfrom tall
tsubjects, tnot tthe tIRB t(21 tCFR t312.60)
D. tThe tregulations trequire teach tIRB tto thave ta tdiversity tof tmembers t(race, tgender,
tcultural tbackgrounds t) t(21 tCFR56.107(a)
Financial tDisclosure tis trequired tfor tinvestigators twho, tduring tthe ttime tthe tclinical
tinvestigator tis tcarrying tout tthe tstudy tand tfor tone tyear tfollowing tthe tcompletion tof
tthe tstudy, thave:
A. tBeen ta tprior temployee tof tthe tsponsor tcompany tand town tstock tworth tmore tthan
t$50,000 tUSD
B. tBeen tpaid t$15,000 tUSD tfor tconducting tclinical ttrials twith tthe tsponsor
C. tA tspouse twho thas tbeen tpaid tas ta tconsultant tby tthe tcompany tbefore tthe tstudy
tbegan
D. tIs tnot ta trequirement tfor tPhase t2 tstudies t- tcorrect tanswers t-A. tBeen ta tprior
temployee tof tthe tsponsor tcompany tand town tstock tworth tmore tthan t$50,000 tUSD
Phase t2 tclinical ttrials tare tbeing tplanned tfor ta tnovel tcancer tdrug. tAll tthe tfollowing
tare tappropriate tfactors tin tthe tphase tof tthe tstudy tEXCEPT?
A. tEnrollment tof tcancer tpatients
B. tEnrollment tof thealthy tsubjects
C. tStudy tof tone tor tmore tindications
D. tCollection tof tefficacy tdata t- tcorrect tanswers t-C. tStudy tof tone tor tmore tindications
Sponsors tof ta tclinical ttrial tmust timmediately tnotify tFDA tand tinvestigators tof tSAEs
tEXCEPT?
A. tTemporally tassociated twith tthe tuse tof tthe tinvestigational titem tbut tare tnot tserious
tand/or tunexpected
B. tDescribed tin tthe tIB tbut twith tgreater tseverity
C. tLife-threatening tor tresult tin tinpatient thospitalization
D. tFindings tfrom tanimal tor tin tvitro ttesting tthat tsuggest ta tsignificant trisk tin thumans
texposed tto tthe tdrug t- tcorrect tanswers t-A. tTemporally tassociated twith tthe tuse tof
tthe tinvestigational titem tbut tare tnot tserious tand/or tunexpected
EXAM FINAL WITH ALL GRADED A+
SOLUTIONS
According tto tthe tQuality tSystem tRegulation, twhen tan tinvestigation tof ta tcomplaint tis
tconducted tall tof tthe tfollowing tare trequirements tfor tinclusion tin tthe trecord tof tthe
tinvestigation tEXCEPT:
A. tThe tdates tand tresults tof tthe tinvestigation
B. tThe tnature tand tdetails tof tthe tcomplaint
C. tChanges tin tprocedures tcorrecting tquality tproblems
D. tAny treply tto tthe tcomplainant t- tcorrect tanswers t-C.
A tregulatory taffairs tprofessional twants tto tschedule ta tpre-NDA tmeeting twith tFDA.
tHe tor tshe tshould:
,A. tWrite ta tletter tto tFDA trequesting ta tType tA tmeeting tas tan tamendment tto tthe tIND
B. tRequest ta tType tB tmeeting tas tan tamendment tto tthe tIND
C. tCall tthe tproject tmanager tand tset tup ta tdate tover tthe tphone tfor ta tType tC
tmeeting
D. tEmail tthe tdivision tdirector twith ta tlist tof tthree tdates, t30 tdays tinto tthe tfuture t-
tcorrect tanswers t-B.
Following tthe t"elixir tof tSulfanilamide" ttragedy, tpublic toutcry tled tto tthe t1938 tpassage
tof t
A. tThe tPure tFood tand tDrug tAct
B. tThe tFederal tFood tDrug tand tCosmetic tAct
C. tThe tKefauver-Harris tDrug tAmendments
D. tThe tPublic tHealth tService tAct t- tcorrect tanswers t-B. tThe tFederal tFood tDrug tand
tCosmetic tAct
What tproducts tare texempt tfrom tthe tPrescription tDrug tUser tFees tAct t(PDUFA)? t
A. tGeneric tdrugs tonly
B. tOrphan tdrugs tand tcosmetics tonly
C. tOTC tdrugs, tcosmetics, tgeneric tdrugs tand tmedical tdevices
D. tPrescription tdrugs tmarketed tbefore t1992 t- tcorrect tanswers t-C. tOTC tdrugs,
tcosmetics, tgeneric tdrugs tand tmedical tdevices
Which tis tnot ta tdivision tof tthe tFDA?
A. tCDRH
B. tCDER
C. tCFER
D. tCVM t- tcorrect tanswers t-C. tCFER
What tis tthe tmission tof tthe tFDA?
A. tPromote tpublic thealth t
B. tProtect tpublic thealth t
C. tPursue tinternational tharmonization t
D. tAll tof tthe tabove t- tcorrect tanswers t-D. tAll tof tthe tabove
The tFreedom tof tInformation tAct tprohibits tFDA tfrom tpreventing tthe trelease tof tFDA-
generated trecords:
tTrue tor tFalse t- tcorrect tanswers t-FALSE
Veterinary tdrugs tare tregulated tunder tthe tCenter tfor tDrug tEvaluation tand tResearch
t(CDER), tbecause tthe trequirements tfor tapproval tare tthe tsame:
tTrue tor tFalse t- tcorrect tanswers t-FALSE
,In torder tof thighest tlevel tto tlowest tlevel, tthe tranking tat tUS tgovernmental
torganizations tis:
A. tDivision, tOffice, tCenter, tAgency, tDepartment
B. tDepartment, tAgency, tCenter, tOffice, tDivision
C. tCenter, tDepartment, tDivision, tAgency, tOffice
D. tAgency, tCenter, tOffice, tDepartment, tDivision t- tcorrect tanswers t-B. tDepartment,
tAgency, tCenter, tOffice, tDivision
For tnonclinical tstudies tlasting tmore tthan t6 tmonths, tquality tassurance taudits tare
tconducted tat twhich tof tthe tfollowing tintervals?
A. t1 tmonth
B. tquarterly
C. tat tcompletion
D. tperiodically t- tcorrect tanswers t-D. tperiodically
Audits tshould tbe tconducted tat tintervals tappropriate tto tassure tthe tintegrity tof tthe
tstudy t(rules tout tanswers tA,B tand tC). t
Periodic tauditing tby tthe tquality tassurance tunit tis trequired tas tappropriate tfor tthe
tstudy t(21CFR58.35(b)(3)
Good tLaboratory tPractices tRegulations tgovern tthe:
A. tConduct tand tcontrol tof tlaboratory tactivities
B. tConduct tof tnonclinical tlaboratory tstudies
C. tDetermination tof tproduct tefficacy tin tanimals
D. tDetermination tof tproduct tfeasibility t- tcorrect tanswers t-B. tConduct tof tnonclinical
tlaboratory tstudies
A. tThe tregulation tdoes tnot tcover tphysical tor tchemical ttesting
B. t21 tCFR t58.3(d) tpertains tto tnonclinical tlaboratory ttesting tto tdetermine tsafety
C. tTesting tto tdetermine tutility tis texcluded
D. tBasic texploratory tstudies tare texcluded
Consent tfrom tsubjects tfor tclinical tstudy tenrollment tis ta:
A. tProposed trule
B. tFinal trule
C. tRecommendation t
D. tGuideline t- tcorrect tanswers t-B. tFinal trule
The tFDA tregulation ton tinformed tconsent tbecame ta tfinal trule ton t27 tJanuary t1981
t(21 tCFR t50)
All tof tthe tfollowing tare trequirements tof tan tIRB, tEXCEPT
, A. tHas tat tleast t5 tmembers
B. tIncludes tat tleast t1 tnonscientific tmember
C. tObtains tinformed tconsent tfrom tall tsubjects
D. tRepresents tthe tcultural tmix tof tthe tcommunity t- tcorrect tanswers t-C. tObtains
tinformed tconsent tfrom tall tsubjects
A. tIt tis ta trequirement tthat teach tIRB thave tat tleast t5 tmembers t(21 tCFR56.107(a)
B. tThe tregulations trequire teach tIRB tto thave tat tleast t1 tmember twhose tprimary
tconcerns tare tin tthe tscientific tarea tand tat tleast t1 twhose tprimary tconcerns tare tin
tnonscientific tareas t((21 tCFR56.107(c)
C. tIt tis tthe tresponsibility tof tthe tclinical tinvestigator tto tobtain tconsent tfrom tall
tsubjects, tnot tthe tIRB t(21 tCFR t312.60)
D. tThe tregulations trequire teach tIRB tto thave ta tdiversity tof tmembers t(race, tgender,
tcultural tbackgrounds t) t(21 tCFR56.107(a)
Financial tDisclosure tis trequired tfor tinvestigators twho, tduring tthe ttime tthe tclinical
tinvestigator tis tcarrying tout tthe tstudy tand tfor tone tyear tfollowing tthe tcompletion tof
tthe tstudy, thave:
A. tBeen ta tprior temployee tof tthe tsponsor tcompany tand town tstock tworth tmore tthan
t$50,000 tUSD
B. tBeen tpaid t$15,000 tUSD tfor tconducting tclinical ttrials twith tthe tsponsor
C. tA tspouse twho thas tbeen tpaid tas ta tconsultant tby tthe tcompany tbefore tthe tstudy
tbegan
D. tIs tnot ta trequirement tfor tPhase t2 tstudies t- tcorrect tanswers t-A. tBeen ta tprior
temployee tof tthe tsponsor tcompany tand town tstock tworth tmore tthan t$50,000 tUSD
Phase t2 tclinical ttrials tare tbeing tplanned tfor ta tnovel tcancer tdrug. tAll tthe tfollowing
tare tappropriate tfactors tin tthe tphase tof tthe tstudy tEXCEPT?
A. tEnrollment tof tcancer tpatients
B. tEnrollment tof thealthy tsubjects
C. tStudy tof tone tor tmore tindications
D. tCollection tof tefficacy tdata t- tcorrect tanswers t-C. tStudy tof tone tor tmore tindications
Sponsors tof ta tclinical ttrial tmust timmediately tnotify tFDA tand tinvestigators tof tSAEs
tEXCEPT?
A. tTemporally tassociated twith tthe tuse tof tthe tinvestigational titem tbut tare tnot tserious
tand/or tunexpected
B. tDescribed tin tthe tIB tbut twith tgreater tseverity
C. tLife-threatening tor tresult tin tinpatient thospitalization
D. tFindings tfrom tanimal tor tin tvitro ttesting tthat tsuggest ta tsignificant trisk tin thumans
texposed tto tthe tdrug t- tcorrect tanswers t-A. tTemporally tassociated twith tthe tuse tof
tthe tinvestigational titem tbut tare tnot tserious tand/or tunexpected
