Exam (elaborations)
ACRP CCRC Exam Prep Questions (Latest 2023 – 2024) With Verified Answers
ACRP CCRC Exam Prep Questions (Latest 2023 – 2024) With
Verified Answers
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ACRP CCRC Exam Prep Questions (Latest 2023 – 2024) With
Verified Answers
Aspatientscannotsrecallsthesnamesofsthesheartsconditionsmedicationshestooksasfewsyearssago.s
Thississimportantsinformationsforsdecidingswhethersthespatientsmaysbesenrolledsinsasclinicals
trials(IC/EC).sWhat'ssyoursbestscoursesofsaction?s-
sYousattemptstosretrievesthespatientssmedicalshistorysbyscontactingspreviousscaregiverssands
youswaitsforsadditionalsinformationsbeforesenrollment.
Whoshassultimatestrialsresponsibilitysforseachssubject?s-sThesprinciplesinvestigator.
Astrialssubjectssufferssfromsseveresrepeatsheadaches.sShouldsthissadverseseventsbesreporteds
tosthesIRB?s-sNo
Whatsstatementssarestruesconcerningsansadversesdrugsreaction?s-s-
sAllsnoxioussandsunintendedsresponsesstosasmedicinalsproductsrelatedstosanysdosesshouldsbe
sconsideredsassansADR
-sAnsADRssuggestssasrelationshipstostrailsmedication
-sAllsADRssmustsbesdocumented
WhatsAdversesEventss(AEs)saresSerioussAdversesEventss(SAEs)?s-s-
sAnysAEsthatsresultssinsdeath
-sAnysAEsthatsresultssinsinpatientshospitalization
-sAnysAEsthatsissascongenitalsanomaly
Duringsasstudysvisitsaspatientstellssthesinvestigatorsthatsshesvisitedsansemergencysroomsands
receivedsintensivestreatmentsforsallergicsbronchospasm.sSincesthespatientswassinsthesemerg
encysroomsforsonlysthreeshours,sthesinvestigatorsdidsnotsassessstheseventsassserious.sIssthissa
scorrectsassessment?s-
sNo,sthisswouldsbesasmedicallysimportantseventsandsshouldsbesconsideredsserious
WhatsdataspointssminimallysneedstosbesreportedsbysthessiteswhensreportingsansSAE,ssosthatst
hessponsorscansprocesssthesevent?s-sIdentificationsofsevent,sproduct,sandstrialssubject
Duringsasvisitswithsinvestigator,sassubjectsreportedsfeelingsheartspalpitationssforsasbriefsperi
odsofstimesduringsthesprevioussevening.sThesheartspalpitationssresolvedswithoutsreoccurren
ce.sThesinvestigatorsconsideredsthesessymptomsstosbesunrelatedstosstudysdrug.sThesnextsday
,sthessubjectstoldsasfellowsstudentsthatshesfeltstiredsandswassplanningsonstakingsasnap.sLater,st
hessubjectswassfoundsdead.sAspreliminarysreportsfromsthesmedicalsexaminersindicatedsthess
ubjectsdiedsofspulmonarysembolism.sWhatsshouldsyoursnextscoursesofsactionsbe?s-s-
sRecordstheseseventssinscasesreportsform
-sImmediatelysnotifyssponsorsaboutsserioussadversesevents
WhensaskedsbysasregulatorysbodyswhystheysreceivedsSAEsrelatedsinformationsons12/2013sf
romsansincidentsthatsoccurredsins5/2013,sthessponsorsexplainedsthesreasonsbeingstheysrecei
,vedsthestrialsrelatedsSAEsinformationsfromsthesinvestigatorsins12/2013.sIssthessponsorscorre
ctsinsonlysholdingsthesinvestigatorsaccountablesforstheirslatesreporting?s-
sNo,sthessponsorsshouldssupportsthesconductsQCsactivitiesswithsthessitesstoshelpsthemsensure
stimelysSAEsreporting.
Astrialssubjectsinsascardiologystrialsissadmittedstoshospitalswithsheartsattack.sThesinvestigato
rsconsiderssthisseventspossiblysrelatedstosthesstudysdrugsevensthoughsthississnotslistedsinsthes
IBsassaspotentialsadversesreaction.sWhatswouldsthesinvestigatorsreportsthisseventstosthesspo
nsorsas?s-sAnsunexpected,sserioussadversesevent
As22y/osmaleswassenteredsintosasclinicalsstudysforstreatmentsofsschizophreniasThesstudysdr
ugswassadministeredsorally,sBID.sOnesweekslater,sthessubjectsvisitedsthesinvestigatorscompla
iningsofsseverssoresthroat.sThesIBslistssthissassansoccurrencesreportedsbys1%sofssubjectssrece
ivingsdrug.sHowsshouldsthissseveresthroatsbesclassified?s-s-sAnsadversesevent
-sAnsadversesdrugsreaction
InsregardsstosAEsandsADRsreporting,swhatsstatementssarestrue?s-s-
sAllsADRssaresAEssbutsnotsallsAEssaresADRs
-sWorseningsinspre-existingsmedicalsconditionssissansAE
-PreplannedshospitalizationsissusuallysnotsansSAE
Whatsdeterminessthescausalitysofsansadversesevent?s-sThesinvestigator
WhichstermsbestsdescribessthescyclicalsprocesssthatsinvolvessthesPlan,sDo,sCheck,sActsactiviti
es?s-sQualitysimprovement
Whichstermsbestsdescribessansindependentsassessmentsofscompletedsworkstosensuresitswills
meetsapplicablesqualitysstandards?s-sQualitysassurance
Whichstermsbestsdescribessthesactivitiessdonestosensuresqualitysoutput?s-sQualityscontrol
Whichstermsrequiressstructuresandsasdefinitionsofsacceptablesstandardssofsperformance?s-
sQualitysplanning
WhichsissrepresentedsinsALCOA-C?s-sAttributable
WhatsdoessCAPAsstandsfor?s-sCorrectivesandsPreventivesAction
Whensnotscompletedscorrectly,swhichsissasmajorscontributingsfactorstosansineffectivesCAPAsp
lan?s-sRootscausesanalysis
Whatsaresthescyclicalsactivitiessperformedsaspartsofsqualitysimprovement?s-
sPlan,sDo,sCheck,sAct
Whatsisssuedstosdeterminesrootscauses?s-s-sFishbonesdiagram
-sProcesssflowscharts
, -sThes5sWhys
Whatsaresfishbonesdiagrams,sprocesssflowscharts,sandsthes5swhyssusedsforsdetermining?s-
sRootscauses
Whatsisstheskeysdifferencesbetweensqualitysimprovementsandsqualitysassurancesactivities?s-
sCansbesperformedsbyspersonssinvolvedsinsdoingstheswork.
Whatsarestheselementssofsqualitysmanagementssystem?s-s-sQualitysplanning
-sQualitysassurance
-sQualityscontrol
Whatsisspartsofsasqualitysmanagementsplan?s-s-sQualityspolicysstatement
-sQualitysgoals
-sOrganizationalsstructureswithsdefinedsroles
Whatsdocumentsssupportsqualityscontrol?s-s-sSOPS,s
-sConcomitantsmedicationslog
Qualitysstandardssaressetsby?s-s-sRegulatorysbodies
-sIRB/IECs
Whatsaresthesbasicsstepssofsrisksmanagement?s-s-sAnalyzesrisk
-sIdentifysrisk
-sControlsrisk
AdheringstosthesprinciplessrepresentedsinsALCOA-Cssupport?s-
sGoodsdocumentationspractice.
WhatsaresthescorrectsordersofsstepssCAPAsperforms?s-s-sIdentifysissue
-sDeterminesrootscause
-sImplementsplansforscorrection
-sAssessseffectivenesssofscorrection
Havingswhichstwospeoplessignsandsdatesthesconsentsformsissasqualitysstandardsforsthesinfor
medsconsentsdocumentation?s-sThessubjectsandsthespersonsobtainingsconsent.
TruesorsFalse.sMovingsawaysfromspreventingsproblemsstosidentifyingsandscorrectingsproble
mssissaskeysparadigmsshiftstakingsplacesinsclinicalstrialsconduct.s-sFalse
TruesorsFalse.sWhensengagedsinsqualitysimprovementsactivities,sit'ssimportantstosidentifysw
hosisstosblamesforsqualitysfailure?s-sFalse
Whatsskillssaresessentialsforsmakingsrisksbasedsdecisionsmakingssuccessful?s-s-
sQualityscontrolsskills
-sMotivationalsskills