Exam (elaborations)
CHRC Exam Questions with 100% Correct Answers | Latest Version (2024/2025) Expert Verified
- Course
- Institution
CHRC Exam Questions with 100% Correct Answers | Latest Version (2024/2025) Expert Verified
[Show more]
Content preview
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.
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller professoraxel. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $16.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
85169 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now