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COMPLETE 550 REAL EXAM
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Duringmthemclinicalmtrial,mregulationsmrequiremthatmamsubjectmbemgivenmthemrightmto...
a.mTravel
b.mWithdrawmatmanymtime
c.mGetmfinancialmcompensation
d.mSpeakmtomamsponsor'smattorneym-mCORRECTmANSWERmc.mWithdrawmatmanymtime
WhichmsignaturesmaremrequiredmbymFDAmregulationmtombemonmthemconsentmform?
a.Theminvestigator
b.mThemsubject
c.mTheminvestigatormandmsubject
d.mThemsubjectmandmamwitnessm-mCORRECTmANSWERmb.mThemsubject
Whichmofmthemfollowingmstatementsmdescribesmanmadequatemandmwell-controlledmtrial?
a.mThemtrialmismcloselymmonitored
,b.mThemIPmmeetsmGMPmstandards
c.mThemeffectsmofmthemIPmcanmbemassessed
d.mSourcemdocumentationmismverifiedmformallmsubejctsm-
mCORRECTmANSWERmc.mThemeffectsmofmthemIPmcanmbemassessed
Whichmofmthemfollowingmrepresentsmwell-writtenminclusion/exclusionmcriteriamformanmanti-
hypertensivemprotocol?
1.msatisfactorymstressmtest
2.musemofmamHoltermmonitor
3.mnompreviousmhistorymofmstroke
4.mdiastolicmbloodmpressuremgreatermthanm100
a.m1mandm2monly
b.m1mandm3monly
c.m2mandm4monly
d.m3mandm4monlym-mCORRECTmANSWERmd.m3mandm4monly
Intent-to-treatmtrialmdatamanalysismonlymincludesmsubjectsmwhomwerem__________.
a.mscreened
b.mcompleted
c.mrandomized
d.mdiscontinuedm-mCORRECTmANSWERmc.mrandomized
Amtrialmprotocolmamendmentmismrequiredmifmtheremis:
, a.mamreplacementmofmamsite
b.mamsiteminvestigatormchange
c.manmincreaseminmthemsamplemsize
d.mammergerminvolvingmthemsponsorm-mCORRECTmANSWERmc.manmincreaseminmthemsamplemsize
Inmamdouble-
blindmtrialmcomparingmIPmAmtomIPmB,mthemtreatmentmwillmbemeithermq.d.mxm7mdaysmonmIPmAmormb.i.d.
mxm10mdaysmonmIPmBm(1:1).mThemcountriesmparticipatingmwillmbemthemUS,mCanada,mMexico,mandmthem
UK.mThemUSmhasmbeenmallocatedm2mtimesmmoremsubjectsmthanmeachmothermcountry.mThemtrialmnee
dsm2000msubjects,mandminmordermtommakemsuremtheremismamsufficientmsupply,mthemsponsormwillmadd
mamsupplymoveragemofm20%.mFormCanada,mhowmmanymcapsulesmofmeachmproductmwillmneedmtombem
producedmformthismtrial?
a.m1680mIP;m4800mIP
b.m3360mIP;m9600mIP
c.m2800mIP;m8000mIP
d.m8400mIP;m24,000mIPm-mCORRECTmANSWERma.m1680mIP;m4800mIP
WhenmchoosingmamCROmtommanagemamclinicalmtrial,mwhichmofmthemfollowingmaremrequiredmbymICHm
Guidelines?
1.mTransfermofmresponsibilitiesmmustmbemdocumentedminmwriting.
2.mResponsibilitiesmtransferredmtomthemCROmbecomemthemultimatemresponsibilitymofmthemCRO.
3.mAmsponsormmustmtransfermallmofmthemresponsibilitiesmtomonemCRO.
4.mObligationsmnotmdescribedminmanymwrittenmagreementmshallmbemdeemedmnotmtomhavemtransferr
ed.
a.m1mandm3monly