SOCRA CERTIFICATION EXAM | NEWEST
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ACTUAL EXAM COMPREHENSIVE QUESTIO
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NS AND VERIFIED ANSWERS GRADED A+ |
g g g g g g g
100% PASS | 2024 UPDATE!
g g g g
WhengcangangIRBgusegangexpeditedgreviewgmethod?g-
g ✔✔✔gCorrectgAnswerg >gResearchgisgnogmoregthangminimalgriskgORgmi
norgchangesgtogpreviouslygapprovedgresearch
Whogreceivesgtheginvestigator'sgbrochure?g-g ✔✔✔gCorrectg Answerg >
Everygparticipatinggclinicalginvestigator
Howglonggdoesgagsponsorgneedgtogkeepgrecordsgaftergagmarketinggapplica
tiongforgagdruggisgapproved?g-g ✔✔✔gCorrectg Answerg >g 2gyears
WhatgcriteriagmustgbegmetgforgangIRBgtogapprovegagstudy?g-g ✔✔✔
Correctg Answerg >g-RisksgaregMINIMIZED
-Risksgaregreasonablegingproportiongtogbenefits
-Selectiongofgsubjectsgisgequitable
-Informedgconsentgwillgbegsought
-Informedgconsentgwillgbegappropriatelygdocumented
-Datagwillgbegmonitoredgforgsubjectgsafety
,-Adequategprovisionsgtogprotectgprivacygandgconfidentiality
-Additionalgsafeguardsgaregingplacegforgvulnerablegsubjects
-AllgresearchgisgingcomplianacegwithgFDAgpartg50,gsubpartgD
Whogisgultimatelygresponsiblegforgthegpropergconductgofgagstudy?g-
✔✔✔gCorrectg Answerg >gSponsor.gTheygselectgmonitorsgandginvestigato
rs.
Doginvestigatorsgneedgtogsupplygsponsorsgwithgagwholeghostgofginformati
on,gkindgofglikegaggrantgapplication?g-g ✔✔✔gCorrectg Answer
>g Yes
CangFDAginspectgwhenevergtheygwant?g-
g ✔✔✔gCorrectg Answerg >gYesgigthinkgso
Whatgaregthegresponsibilitiesgofgtheginvestigator?g-
g ✔✔✔gCorrectgAnswerg >gUpholdgtheirginvestigator'sgagreementgandgc
onductgstudygaccordinggtogplan.gObtainginformedgconsent.
Whatgtypegofgrecordsgtoginvestigatorsgneedgtogkeep,gandgforghowglongg
aftergmarketinggapproval?g-
g✔✔✔gCorrectgAnswerg>gDispositiongofgdruggrecords,gcaseghistories.
gForg2gyears.
,WhogsubmitsgannualgreportsgtogFDA,gtheginvestigatorgorgthegsponsor?g-
✔✔✔gCorrectg Answerg >g Thegsponsor.
WhogsubmitsgreportsgofgSAEs,gandgtogwhom?g-g ✔✔✔gCorrectg Answer
>g Theginvestigatorsgreportgtogthegsponsor,gandgalsogtogthegIRBgigthink
Cangagclinicalginvestigatorgbegdisqualified?gWhygmightgthatgbegthegcase?
-g ✔✔✔gCorrectg Answerg >gYesg-
gifgrepeatedlygorgdeliberatelygfailedgtogcomplygwithgsubparts,gagreements
getc,gorgfalsifiedganyginformation.
Isgtheregagdifferentgsetgofgregulationsgwhengitgcomesgtoglife-threatening
/gdebilitatinggdiseasesgforgwhichgnoggoodgalternativesgexist?g-g ✔✔✔
Correctg Answerg >gYes,gevaluategthegrisk-benefitgratiogdifferently
Cangdrugsgbegimportedgandgexportedgforgclinicalgtrials?g-
g ✔✔✔gCorrectgAnswerg >gYes,gundergspecifiedgcircumstancesgandgwithg
propergreviewgetc.
CangthegFDAg"rely"gongang"external"gFDAgingagmulti-nationalgtrial?g-
✔✔✔gCorrectg Answerg >gYesg-
gyougcangacceptgforeigngIND'sgifgtheygweregconductedgundergGCPgetc,gifgt
hegFDAgcangvalidategthegdata,gandgalsogneedgtogsubmitglotsgofgregulatory
gstuff.
IsgangINDgapplicationgautomaticallygpublicgknowledge?g-
g ✔✔✔gCorrectgAnswerg >gNo,gitgcangbegifginvestigator'sgwantgitgtogbe.
, expandedgaccessg-
g ✔✔✔gCorrectg Answerg >gThegusegofganginvestigationalgnewgdrugg(IND)
goutsidegofgagclinicalgtrialgbygpatientsgwithgseriousgorglife-
threateninggconditionsgwhogdognotgmeetgthegenrollmentgcriteriagforgtheg
clinicalgtrialgingprogress.gRequiresgangapplication.
Cangagspecialgaccessgbeggrantedgforgsmallgpatientgpopulations,gi.e.gorpha
ngdrugs,gorphangconditions?g-g ✔✔✔gCorrectg Answerg >gYesg-
gspecialgconsiderations.
Dogthegpoliciesgofgdevicesglargelygmirrorgthegpoliciesgforginvestigationalgn
ewgdrugs?g-g ✔✔✔gCorrectg Answerg >gYes,gmirroredgclosely
FederalgRegulationsgPartg45/46g-
g ✔✔✔gCorrectg Answerg >gProtectiongofgHumangSubjectsg-
gProtectiongofgPublicgWelfare
FederalgRegulationsgPartg21g-
g ✔✔✔gCorrectg Answerg >gElectronicgRecords,gHumangSubjectsg(50),gIRB
,gIND,gInvestigationalgDevices
04955Dg-g ✔✔✔gCorrectg Answerg >g authgcodegsmh
Whatgtypesgofhumangsubjectsgresearchgcouldgbegconsideredgexemptgfro
mghumangsubjectsgreview/regulation?g-
g ✔✔✔gCorrectg Answerg >gSchools,geducationalgtests,gunidentifiablegsu
g g g g
ACTUAL EXAM COMPREHENSIVE QUESTIO
g g g
NS AND VERIFIED ANSWERS GRADED A+ |
g g g g g g g
100% PASS | 2024 UPDATE!
g g g g
WhengcangangIRBgusegangexpeditedgreviewgmethod?g-
g ✔✔✔gCorrectgAnswerg >gResearchgisgnogmoregthangminimalgriskgORgmi
norgchangesgtogpreviouslygapprovedgresearch
Whogreceivesgtheginvestigator'sgbrochure?g-g ✔✔✔gCorrectg Answerg >
Everygparticipatinggclinicalginvestigator
Howglonggdoesgagsponsorgneedgtogkeepgrecordsgaftergagmarketinggapplica
tiongforgagdruggisgapproved?g-g ✔✔✔gCorrectg Answerg >g 2gyears
WhatgcriteriagmustgbegmetgforgangIRBgtogapprovegagstudy?g-g ✔✔✔
Correctg Answerg >g-RisksgaregMINIMIZED
-Risksgaregreasonablegingproportiongtogbenefits
-Selectiongofgsubjectsgisgequitable
-Informedgconsentgwillgbegsought
-Informedgconsentgwillgbegappropriatelygdocumented
-Datagwillgbegmonitoredgforgsubjectgsafety
,-Adequategprovisionsgtogprotectgprivacygandgconfidentiality
-Additionalgsafeguardsgaregingplacegforgvulnerablegsubjects
-AllgresearchgisgingcomplianacegwithgFDAgpartg50,gsubpartgD
Whogisgultimatelygresponsiblegforgthegpropergconductgofgagstudy?g-
✔✔✔gCorrectg Answerg >gSponsor.gTheygselectgmonitorsgandginvestigato
rs.
Doginvestigatorsgneedgtogsupplygsponsorsgwithgagwholeghostgofginformati
on,gkindgofglikegaggrantgapplication?g-g ✔✔✔gCorrectg Answer
>g Yes
CangFDAginspectgwhenevergtheygwant?g-
g ✔✔✔gCorrectg Answerg >gYesgigthinkgso
Whatgaregthegresponsibilitiesgofgtheginvestigator?g-
g ✔✔✔gCorrectgAnswerg >gUpholdgtheirginvestigator'sgagreementgandgc
onductgstudygaccordinggtogplan.gObtainginformedgconsent.
Whatgtypegofgrecordsgtoginvestigatorsgneedgtogkeep,gandgforghowglongg
aftergmarketinggapproval?g-
g✔✔✔gCorrectgAnswerg>gDispositiongofgdruggrecords,gcaseghistories.
gForg2gyears.
,WhogsubmitsgannualgreportsgtogFDA,gtheginvestigatorgorgthegsponsor?g-
✔✔✔gCorrectg Answerg >g Thegsponsor.
WhogsubmitsgreportsgofgSAEs,gandgtogwhom?g-g ✔✔✔gCorrectg Answer
>g Theginvestigatorsgreportgtogthegsponsor,gandgalsogtogthegIRBgigthink
Cangagclinicalginvestigatorgbegdisqualified?gWhygmightgthatgbegthegcase?
-g ✔✔✔gCorrectg Answerg >gYesg-
gifgrepeatedlygorgdeliberatelygfailedgtogcomplygwithgsubparts,gagreements
getc,gorgfalsifiedganyginformation.
Isgtheregagdifferentgsetgofgregulationsgwhengitgcomesgtoglife-threatening
/gdebilitatinggdiseasesgforgwhichgnoggoodgalternativesgexist?g-g ✔✔✔
Correctg Answerg >gYes,gevaluategthegrisk-benefitgratiogdifferently
Cangdrugsgbegimportedgandgexportedgforgclinicalgtrials?g-
g ✔✔✔gCorrectgAnswerg >gYes,gundergspecifiedgcircumstancesgandgwithg
propergreviewgetc.
CangthegFDAg"rely"gongang"external"gFDAgingagmulti-nationalgtrial?g-
✔✔✔gCorrectg Answerg >gYesg-
gyougcangacceptgforeigngIND'sgifgtheygweregconductedgundergGCPgetc,gifgt
hegFDAgcangvalidategthegdata,gandgalsogneedgtogsubmitglotsgofgregulatory
gstuff.
IsgangINDgapplicationgautomaticallygpublicgknowledge?g-
g ✔✔✔gCorrectgAnswerg >gNo,gitgcangbegifginvestigator'sgwantgitgtogbe.
, expandedgaccessg-
g ✔✔✔gCorrectg Answerg >gThegusegofganginvestigationalgnewgdrugg(IND)
goutsidegofgagclinicalgtrialgbygpatientsgwithgseriousgorglife-
threateninggconditionsgwhogdognotgmeetgthegenrollmentgcriteriagforgtheg
clinicalgtrialgingprogress.gRequiresgangapplication.
Cangagspecialgaccessgbeggrantedgforgsmallgpatientgpopulations,gi.e.gorpha
ngdrugs,gorphangconditions?g-g ✔✔✔gCorrectg Answerg >gYesg-
gspecialgconsiderations.
Dogthegpoliciesgofgdevicesglargelygmirrorgthegpoliciesgforginvestigationalgn
ewgdrugs?g-g ✔✔✔gCorrectg Answerg >gYes,gmirroredgclosely
FederalgRegulationsgPartg45/46g-
g ✔✔✔gCorrectg Answerg >gProtectiongofgHumangSubjectsg-
gProtectiongofgPublicgWelfare
FederalgRegulationsgPartg21g-
g ✔✔✔gCorrectg Answerg >gElectronicgRecords,gHumangSubjectsg(50),gIRB
,gIND,gInvestigationalgDevices
04955Dg-g ✔✔✔gCorrectg Answerg >g authgcodegsmh
Whatgtypesgofhumangsubjectsgresearchgcouldgbegconsideredgexemptgfro
mghumangsubjectsgreview/regulation?g-
g ✔✔✔gCorrectg Answerg >gSchools,geducationalgtests,gunidentifiablegsu
