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CHRC Exam Questions with 100% Correct Answers | Latest Version (2024/2025) Expert Verified
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CHRC Exam Questions with 100% Correct Answers | Latest Version (2024/2025) Expert Verified
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CHRC Exam Questions with 100% CorrectAnswers | Latest Version (2024/2025) Expert
Verified
InformediConsenti-iCorrectiAnswer-
Aistatementithatitheistudyiinvolvesiresearch.iExplanationiofipurposeiofi
research.iExpectedidurationiofisubject'siparticipation.iProceduresitoibei
followed.iIdentificationiofiexperimentaliprocedures.iReasonablyiforese
eableirisksioridiscomforts.iBenefitsitoisubjectioritoiothersiexpected.iStat
ementidescribingiconfidentialityiofirecordsiidentifyingitheisubject.iDiscl
osureiofialternativeiproceduresianditreatment.iExplanationiofiCompens
ationiforiInjury.iWhoitoicontactiwithiquestions.iParticipationiisivoluntar
y.iWritteni8thigradeilevel.
CommoniRulei-iCorrectiAnswer-
Theiethicaliprinciplesi(i.e.,irespectiofipersons,ibeneficenceiandijustice)it
hatiformitheifoundationiofihumanisubjectsiprotectionsiinitheiUSiwereico
difiediiniOHRPiregulationsiini1991iwithiTheiFederaliPolicyiforitheiProtect
ioniofiHumaniSubjects,ialsoiknowniasitheiCommoniRule.i45iCFRiParti46
GoodiClinicaliPracticei-iCorrectiAnswer-
Internationaliethicaliandiscientificiqualityistandardiforihumanisubjectsir
esearch.iProvidesiaiunifiedistandardiforitheiconductioficlinicaliresearchit
hatiengendersipubliciassuranceithatitheirights,isafety,iandiwell-
beingiofihumanisubjectsiareiprotectediandithatitheiclinicalitrialidataiarei
credible;ipublishedibyiICH
,Inquiryi(ScientificiMisconduct)i-iCorrectiAnswer-
meansiofigatheringiandiinitialifactifindingitoidetermineiwhetherianialleg
ationioriapparentiinstanceiofimisconductiwarrantsianiinvestigationi(i42i
C.F.R.iParti212iandi42iC.F.R.i§i93.307).iTheiinstitutionimusticompleteiitsii
nquiryiwithinisixtyi(60)icalendaridaysiofiitsiinitiationiunlessicircumstanc
esiclearlyiwarrantiailongeriperiod.
ScientificiMisconducti-iCorrectiAnswer-
Definedias:i"Fabrication,ifalsification,ioriplagiarismi(ori"FFP")iiniproposi
ng,iperforming,iorireviewingiresearchioriinireportingiresearchiresults.iRe
searchimisconductidoesinotiincludeihonestierrorioridifferencesiofiopinio
n"i(i42iC.F.R.i§i93.103i).i"Fabricationiisimakingiupidataioriresultsiandireco
rdingiorireportingithem.iFalsificationiisimanipulatingiresearchimaterials,
iequipment,ioriprocesses,iorichangingioriomittingidataioriresultsisuchith
atitheiresearchiisinotiaccuratelyirepresentediinitheiresearchirecord.iPlag
iarismiisitheiappropriationiofianotheriperson'siideas,iprocesses,iresults,i
oriwordsiwithoutigivingiappropriateicredit"i(i42iC.F.R.i§i93.103i).iThisireg
ulationirequiresithatiFFPibeiai"significantideparture"ifromiacceptediprac
ticesiasiopposeditoithei"seriousideviation"istandardiinitheipreviousiregu
lation.
Investigationi(ScientificiMisconduct)i-iCorrectiAnswer-
Ifitheiresultsiofitheiinquiryireflectiailikelihoodiofiscientificimisconduct,ith
eiinstitutioniwillibeginianiinvestigationiwithinithirtyi(30)idaysiofitheicom
pletioniofitheiinquiry.iTheiinstitutionaliofficialimusticontactitheiOfficeiofi
ResearchiIntegrityi(ORI)idirectoriofitheidecisionitoibeginianiinvestigation
ionioribeforeitheidateithatitheiinvestigationibeginsi(i42iC.F.R.i§i93.310i(b)
).iTheiinstitutionimusticompleteitheiinvestigationiwithinioneihundredit
wentyi(120)idaysiofibeginningiit.
,ScientificiMisconductiInvestigatoryiProcedurei-iCorrectiAnswer-
Noticeiofiallegation,iPre-
Inquiry,iInquiry,iInvestigation,iNoticei&iAppeals,iRiskiManagement
Respondenti-iCorrectiAnswer-
Isiaipersoniagainstiwhomianiallegationiofiresearchimisconductiisidirecte
dioriwhoiisitheisubjectiofiresearchimisconductiproceedings.
ScientificiMisconductiConsequencesi-iCorrectiAnswer-
Includeidebarment,isuspension,ilettersiofireprimand,irestrictionionirese
archiactivities,ispecialireviewiofiallirequestsiforiPHSifunding,iimpositioni
ofisupervisionirequirements,iterminationiofigrants,icertificationioriattri
butioniofiallirequestsiforisupportiandireportsitoitheiPHS,iandimorei(42iC.
F.R.i§i93.407).iMoreover,iHHSimayiseekitoirecoveriPHSifundsispentiinisu
pportiofiactivitiesithatiinvolvediresearchimisconduct.iHHSiwilliconsideri
whetheritheiactionsiwereiknowingiorireckless,iwhetheritheiactionsiwere
ipartiofiaipatternioripracticeiofiwrongdoing,itheiimpactiofitheimisconduc
t,itheirespondent'siacceptanceiofiresponsibility,iandiotherimitigatingicir
cumstances.
ConflictiofiInteresti-iCorrectiAnswer-
Conflictsiofiinterestiariseiwhenifinancialioriotheripersonaliconsiderationi
haveitheipotentialitoicompromiseioribiasiprofessionalijudgmentiandiobj
ectivity.iConflictiofiinterestiinevitablyiinvolveitheiuseiofianiindividual'sia
uthorityiforipersonaliand/orifinancialigain.
, SunshineiActi-iCorrectiAnswer-
Requiresimanufacturersiofidrugs,idevicesiandibiologics,itoitrackiandirep
orti(onipubliciwebsites)ianyipaymentsiofi$10iorimoreimadeibyithemitoip
hysicians.iThisiprovisioniappliesitoipharmaceuticalicompanies,ibiotechif
irmsiandimedicalideviceimanufacturersithatihaveiproductsiwhichiareieli
gibleiforipaymentibyiMedicare,iMedicaidioritheiChildren'siHealthiInsura
nceiProgrami(CHIP).
EffortiReportingi-iCorrectiAnswer-
Aimeansiofiverifyingithatitheipercentiofieffortiexpendedibyiresearchiper
sonnelionivariousiactivitiesiisicommensurateiwithitheipercentageiofisala
riesiandiwagesichargeditoithoseiaccounts.iEffortireportingifurtheriverifie
sithaticostisharingicommitmentsiwereimet,itotaliefforticommitmentsiw
ereimetiandithaticostsiwereiappropriatelyitreatediinitheiindirecticostirat
e.
ClinicaliTrialiPolicyi-iCorrectiAnswer-
NationaliCoverageiDeterminationi310.1i(NCDi310.1)iCMS'irequirements
iforicoverageiforicertaini"routineicareiservices"ithatiareiprovidediasiparti
ofiairesearchistudy.
CoverageiAnalysisi-iCorrectiAnswer-
Isiaiformalizedireviewiofiwhatiisiwithiniaiprotocoliandistudyieventicalen
dar,iandiisitheibestipracticeitoiensureithatitheiprotocol-
relatediservicesiareioutlined,iand,iifitheiservicesiwillibeibilleditoiinsuranc
e,ithatiairationaleiisigiven,iwhichiovercomesitheiimplicitipresumptionith
atiaiserviceirequiredibyitheiprotocoliisimedicallyinecessaryiforiallipossibl
eieligibleisubjects.
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