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RAC-Drugs Only All Practice Exam Final Questions and Answers
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RAC-Drugs Only All Practice Exam Final Questions and Answers
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RAC-Drugs Only All Practice Exam FinalQuestions and Answers
According iito iithe iiQuality iiSystem iiRegulation, iiwhen iian iiinvestigation iiof iia iicomplaint
iiis iiconducted iiall iiof iithe iifollowing iiare iirequirements iifor iiinclusion iiin iithe iirecord iiof
iithe iiinvestigation iiEXCEPT:
A. iiThe iidates iiand iiresults iiof iithe iiinvestigation
B. iiThe iinature iiand iidetails iiof iithe iicomplaint
C. iiChanges iiin iiprocedures iicorrecting iiquality iiproblems
D. iiAny iireply iito iithe iicomplainant ii- iiAnswers ii-C.
A iiregulatory iiaffairs iiprofessional iiwants iito iischedule iia iipre-NDA iimeeting iiwith iiFDA.
iiHe iior iishe iishould:
A. iiWrite iia iiletter iito iiFDA iirequesting iia iiType iiA iimeeting iias iian iiamendment iito iithe
iiIND
B. iiRequest iia iiType iiB iimeeting iias iian iiamendment iito iithe iiIND
C. iiCall iithe iiproject iimanager iiand iiset iiup iia iidate iiover iithe iiphone iifor iia iiType iiC
iimeeting
D. iiEmail iithe iidivision iidirector iiwith iia iilist iiof iithree iidates, ii30 iidays iiinto iithe iifuture ii-
iiAnswers ii-B.
Following iithe ii"elixir iiof iiSulfanilamide" iitragedy, iipublic iioutcry iiled iito iithe ii1938
iipassage iiof ii
A. iiThe iiPure iiFood iiand iiDrug iiAct
B. iiThe iiFederal iiFood iiDrug iiand iiCosmetic iiAct
C. iiThe iiKefauver-Harris iiDrug iiAmendments
D. iiThe iiPublic iiHealth iiService iiAct ii- iiAnswers ii-B. iiThe iiFederal iiFood iiDrug iiand
iiCosmetic iiAct
What iiproducts iiare iiexempt iifrom iithe iiPrescription iiDrug iiUser iiFees iiAct ii(PDUFA)? ii
A. iiGeneric iidrugs iionly
B. iiOrphan iidrugs iiand iicosmetics iionly
C. iiOTC iidrugs, iicosmetics, iigeneric iidrugs iiand iimedical iidevices
D. iiPrescription iidrugs iimarketed iibefore ii1992 ii- iiAnswers ii-C. iiOTC iidrugs, iicosmetics,
iigeneric iidrugs iiand iimedical iidevices
Which iiis iinot iia iidivision iiof iithe iiFDA?
,A. iiCDRH
B. iiCDER
C. iiCFER
D. iiCVM ii- iiAnswers ii-C. iiCFER
What iiis iithe iimission iiof iithe iiFDA?
A. iiPromote iipublic iihealth ii
B. iiProtect iipublic iihealth ii
C. iiPursue iiinternational iiharmonization ii
D. iiAll iiof iithe iiabove ii- iiAnswers ii-D. iiAll iiof iithe iiabove
The iiFreedom iiof iiInformation iiAct iiprohibits iiFDA iifrom iipreventing iithe iirelease iiof
iiFDA-generated iirecords:
iiTrue iior iiFalse ii- iiAnswers ii-FALSE
Veterinary iidrugs iiare iiregulated iiunder iithe iiCenter iifor iiDrug iiEvaluation iiand iiResearch
ii(CDER), iibecause iithe iirequirements iifor iiapproval iiare iithe iisame:
iiTrue iior iiFalse ii- iiAnswers ii-FALSE
In iiorder iiof iihighest iilevel iito iilowest iilevel, iithe iiranking iiat iiUS iigovernmental
iiorganizations iiis:
A. iiDivision, iiOffice, iiCenter, iiAgency, iiDepartment
B. iiDepartment, iiAgency, iiCenter, iiOffice, iiDivision
C. iiCenter, iiDepartment, iiDivision, iiAgency, iiOffice
D. iiAgency, iiCenter, iiOffice, iiDepartment, iiDivision ii- iiAnswers ii-B. iiDepartment,
iiAgency, iiCenter, iiOffice, iiDivision
For iinonclinical iistudies iilasting iimore iithan ii6 iimonths, iiquality iiassurance iiaudits iiare
iiconducted iiat iiwhich iiof iithe iifollowing iiintervals?
A. ii1 iimonth
B. iiquarterly
C. iiat iicompletion
D. iiperiodically ii- iiAnswers ii-D. iiperiodically
Audits iishould iibe iiconducted iiat iiintervals iiappropriate iito iiassure iithe iiintegrity iiof iithe
iistudy ii(rules iiout iianswers iiA,B iiand iiC). ii
Periodic iiauditing iiby iithe iiquality iiassurance iiunit iiis iirequired iias iiappropriate iifor iithe
iistudy ii(21CFR58.35(b)(3)
Good iiLaboratory iiPractices iiRegulations iigovern iithe:
A. iiConduct iiand iicontrol iiof iilaboratory iiactivities
,B. iiConduct iiof iinonclinical iilaboratory iistudies
C. iiDetermination iiof iiproduct iiefficacy iiin iianimals
D. iiDetermination iiof iiproduct iifeasibility ii- iiAnswers ii-B. iiConduct iiof iinonclinical
iilaboratory iistudies
A. iiThe iiregulation iidoes iinot iicover iiphysical iior iichemical iitesting
B. ii21 iiCFR ii58.3(d) iipertains iito iinonclinical iilaboratory iitesting iito iidetermine iisafety
C. iiTesting iito iidetermine iiutility iiis iiexcluded
D. iiBasic iiexploratory iistudies iiare iiexcluded
Consent iifrom iisubjects iifor iiclinical iistudy iienrollment iiis iia:
A. iiProposed iirule
B. iiFinal iirule
C. iiRecommendation ii
D. iiGuideline ii- iiAnswers ii-B. iiFinal iirule
The iiFDA iiregulation iion iiinformed iiconsent iibecame iia iifinal iirule iion ii27 iiJanuary ii1981
ii(21 iiCFR ii50)
All iiof iithe iifollowing iiare iirequirements iiof iian iiIRB, iiEXCEPT
A. iiHas iiat iileast ii5 iimembers
B. iiIncludes iiat iileast ii1 iinonscientific iimember
C. iiObtains iiinformed iiconsent iifrom iiall iisubjects
D. iiRepresents iithe iicultural iimix iiof iithe iicommunity ii- iiAnswers ii-C. iiObtains iiinformed
iiconsent iifrom iiall iisubjects
A. iiIt iiis iia iirequirement iithat iieach iiIRB iihave iiat iileast ii5 iimembers ii(21 iiCFR56.107(a)
B. iiThe iiregulations iirequire iieach iiIRB iito iihave iiat iileast ii1 iimember iiwhose iiprimary
iiconcerns iiare iiin iithe iiscientific iiarea iiand iiat iileast ii1 iiwhose iiprimary iiconcerns iiare iiin
iinonscientific iiareas ii((21 iiCFR56.107(c)
C. iiIt iiis iithe iiresponsibility iiof iithe iiclinical iiinvestigator iito iiobtain iiconsent iifrom iiall
iisubjects, iinot iithe iiIRB ii(21 iiCFR ii312.60)
D. iiThe iiregulations iirequire iieach iiIRB iito iihave iia iidiversity iiof iimembers ii(race, iigender,
iicultural iibackgrounds ii) ii(21 iiCFR56.107(a)
Financial iiDisclosure iiis iirequired iifor iiinvestigators iiwho, iiduring iithe iitime iithe iiclinical
iiinvestigator iiis iicarrying iiout iithe iistudy iiand iifor iione iiyear iifollowing iithe iicompletion iiof
iithe iistudy, iihave:
A. iiBeen iia iiprior iiemployee iiof iithe iisponsor iicompany iiand iiown iistock iiworth iimore
iithan ii$50,000 iiUSD
B. iiBeen iipaid ii$15,000 iiUSD iifor iiconducting iiclinical iitrials iiwith iithe iisponsor
C. iiA iispouse iiwho iihas iibeen iipaid iias iia iiconsultant iiby iithe iicompany iibefore iithe iistudy
iibegan
, D. iiIs iinot iia iirequirement iifor iiPhase ii2 iistudies ii- iiAnswers ii-A. iiBeen iia iiprior iiemployee
iiof iithe iisponsor iicompany iiand iiown iistock iiworth iimore iithan ii$50,000 iiUSD
Phase ii2 iiclinical iitrials iiare iibeing iiplanned iifor iia iinovel iicancer iidrug. iiAll iithe iifollowing
iiare iiappropriate iifactors iiin iithe iiphase iiof iithe iistudy iiEXCEPT?
A. iiEnrollment iiof iicancer iipatients
B. iiEnrollment iiof iihealthy iisubjects
C. iiStudy iiof iione iior iimore iiindications
D. iiCollection iiof iiefficacy iidata ii- iiAnswers ii-C. iiStudy iiof iione iior iimore iiindications
Sponsors iiof iia iiclinical iitrial iimust iiimmediately iinotify iiFDA iiand iiinvestigators iiof iiSAEs
iiEXCEPT?
A. iiTemporally iiassociated iiwith iithe iiuse iiof iithe iiinvestigational iiitem iibut iiare iinot
iiserious iiand/or iiunexpected
B. iiDescribed iiin iithe iiIB iibut iiwith iigreater iiseverity
C. iiLife-threatening iior iiresult iiin iiinpatient iihospitalization
D. iiFindings iifrom iianimal iior iiin iivitro iitesting iithat iisuggest iia iisignificant iirisk iiin
iihumans iiexposed iito iithe iidrug ii- iiAnswers ii-A. iiTemporally iiassociated iiwith iithe iiuse iiof
iithe iiinvestigational iiitem iibut iiare iinot iiserious iiand/or iiunexpected
From iia iisubsidiary iiin iiIreland, iiyou iiare iiforwarded iia iireport iithat iia iipatient iitaking iiyour
iidrug iiwas iihospitalized iiwith iia iicase iiof iiStevens-Johnson iisyndrome. iiThis
iihypersensitivity iireaction iiis iinot iilisted iion iiyour iilabel. iiYou iishould iireport iithis iicase iito
iiFDA:
A. iiWithin ii15 iicalendar iidays iiof iireceipt
B. iiWithin ii15 iibusiness iidays iiof iireceipt
C. iiWithin ii10 iibusiness iidays iiof iireceipt
D. iiWith iithe iinext iiperiodic iiadverse iidrug iiexperience iireport ii- iiAnswers ii-A. iiWithin ii15
iicalendar iidays iiof iireceipt
Which iiof iithe iifollowing iisubsystems iiis iiNOT iirequired iiby iiFDA iiin iiorder iito iiimplement
iiand iimaintain iia iiQuality iiSystem?
A. iiProduction iiand iiprocess iicontrols
B. iiTest iiand iicontrol iiarticle iicharacterization
C. iiPackaging iiand iilabeling iicontrols
D. iiFacility iiand iiequipment iicontrols ii- iiAnswers ii-B. iiTest iiand iicontrol iiarticle
iicharacterization
This iiis iirequired iiby ii21 iiCFR ii58.105, iiGood iiLaboratory iiPractice iifor iiNonclinical
iiLaboratory iiStudies, iinot iiby iiquality iisystem iior iiGMP iirequirements. iiNote iithat
iiLaboratory iicontrols iifor iifinished iipharmaceuticals iiare iirequired iiby ii21CFR ii211,
iiSubpart iiI.
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