CRA ACRP Practice Exam (Latest 2024 – 2025)
Questions and Answers With Explanations
Asscreeningslogsissusefulsforsdeterminingswhichsofsthesfollowing?
1.strialsreimbursement
2.ssubjectsIPscompliance
3.sactivesrecruitmentsefforts
4.strendssregardingsevaluablessubjectss-s1sands3sonly.
E6s8.3.20sAsscreeningslogswillsprovidesevidencesofsansinvestigator'sseffortsstosrecruitssubject
ssevensifstheysaresunablestosidentifyssubjectssthatsmeetsentryscriteria,swhichscanshelpsdiscri
minatessitesswhosaresfailingstosmakesanseffortstosrecruitsfromssitesswhoshavesbeensunablestos
enrollssubjectssdespitessubstantialseffortsstosdosso.sInsaddition,ssitescontractssroutinelyscont
ainsprovisionssthatsallowsforspaymentsforssomesorsallsofsthesscreensfailuressevaluatedsatsthes
site,sevensifsthesessubjectssaresnotsenrolled.sInformationsonssubjectsIPscompliancesandsevalu
abilitysisscapturedselsewheresandswouldsnotsappearsonsthesscreeningslog.
Astrialsprotocolsamendmentsissrequiredsifstheresis
A.sasreplacementsofsassite.
B.sassitesinvestigatorschange.
C.sansincreasesinsthessamplessize.
D.sasmergersinvolvingsthessponsor.s-sansincreasesinsthessamplessize.
AsspersICHsE6s6.9.2,sthesnumbersofssubjectssplannedstosbesenrolledsissaskeyscomponentsofspr
otocolssandsamendments.sAnyschangesstosthesoriginalsplannedsnumbersofssubjectsswouldsne
cessitatesansamendmentsassitsaffectssthesstatisticsslinkedstosthesstudy.sWhilesthesICHsE6s6.1ss
tatessthatsthessponsor'ssnamesandsaddress,setc...saresrequired,sasmergersdoessnotsnecessarily
smeansthatsthereswassaschangesinssponsorsnamesorsaddress,setc...sandstherefores(D)sissincorr
ect.sThesguidancesalsosstates,s"...sitesspecificsinformationsmaysbesprovidedsonsseparatesproto
colspage(s),sorsaddressedsinsasseparatesagreement..."swhichsexplainsswhys(A)sands(B)saresno
tsthesbestsanswers.
AftersIPshassbeensshippedsoutstosthestrialssite,sthestrialsmonitorsdiscoverssthatsthesinvestigat
orsagreementshassnotsbeenssigned.sWhichsofsthesfollowingsaresthesBESTscoursessofsactionsfor
sthesCRAstostake?
1.sChecksthessitestrialsbinderstosensuresthatsthesremaindersofsthestrialsdocumentssaresinsorde
r.
2.sDocumentsthatsthereswassansoversightsinsshippingsoutsIPspriorstosthesinvestigatorsagreem
entsbeingssigned.
3.sContactsthessitesandsasksthemstosshipsbacksthesIPstosthesCRA.
,4.sInstructsthessitesthatstheysmaysnotsusesthesIPsuntilsthessignedsagreementsissreceivedsbysth
essponsor.s-s2sands4sonly.
ICHs5.14.2IPsshouldsnotsbesshippedsuntilsallsrequiredsdocumentationsissreceived/reviewsan
dsapprovedsfromsthesinvestigator.sStatementss1s&s3sdosnotsassistsinscorrectingsthesissue,swhi
lesstatementss2s&s4swouldsbesthesbestscoursesofsactionsandswouldsenablesthesCRAstosdocume
ntsthesissuesassitsoccurredsandsinstructingsthesinvestigatorsnotstosusesthesIPsuntilsallsrequire
dsdocumentssweresreceivedsandsapproved.
Asrecruitmentsplanswassdevelopedsbysthesresearchssitesforsasnewsdrugstrialsthatsinvolvessenr
ollmentsofspopulationsbetweensthesagessofs6-
10syearssold.sWhichsofsthesfollowingsactivitiessshouldsthesCRAsconsiderswhensreviewingsthes
site'ssplan?
1.sVerifysthatsthesIRB/IECshassreviewedsthesplan.
2.sVerifysthatsthesIRB/IECshassapprovedsthesplan.
3.sEnsuresthesICFsincludessassentsandsconsent.
4.sEnsuresthesIRB/IECsrequirementssforsassentsaresmet.s-s2sands4sonly.
ICHsE6s4.4.1sspecifiessthatsthesIRB/IECsshouldsprovidesapprovalsofsrecruitmentsproposals,sa
ndsICHsE8s3.1.4.3ssuggestssthatsadditionalscaresshouldsbestakenswhensapprovingsthesrecruit
mentsofsvulnerablespopulations,sincludingsminors.sChildrensaresgenerallysnotsablestoslegallys
consentsforsthemselves,sbutsshouldsindicatestheirsagreementstosparticipatestosthesextentsthe
ysarescapablesofsdoingsso.sIRB/IECssoftensrequeststhatsansage-
appropriatesassentsformsbescreatedsforsthisspurpose.
WhenschoosingsasCROstosmanagesasclinicalstrial,swhichsofsthesfollowingsaresrequiredsbysICHs
Guidelines?
1.sTransfersofsresponsibilitiessmustsbesdocumentedsinswriting.
2.sResponsibilitiesstransferredstosthesCROsbecomesthesultimatesresponsibilitysofsthesCRO.
3.sAssponsorsmuststransfersallsofsthesresponsibilitiesstosonesCRO.
4.sObligationssnotsdescribedsinsanyswrittensagreementsshallsbesdeemedsnotstoshavestransfer
red.s-s1sands4sonly.
ICHsE6s5.2.1ssupportssthatsultimatesresponsibilitysforsdatasqualitysandsintegritysalwayssresi
desswithsthessponsor,smakingsoptions2sincorrect.sICHsE6s5.2sdoessnotsstatesthatsassponsorsca
nsonlystransfersresponsibilitiesstosonesCRO,sthereforesoptions3sissincorrect.
WhichsofsthesfollowingsactivitiessshouldsthesCRAsperformswhensreconcilingsansSAEsReports
withsthesCRF?
1.sEnsurescausalsrelationshipsassessmentsissthessamesonsthesSAEsreportsassthesAEsCRF.
2.sVerifysthesinvestigatorsagreementslistsstheshospitalswheresthessubjectswasstreated.
3.sSubmitsinitialsandsanysfollow-upsSAEsreportsstosthesIRB/IEC.
, 4.sConfirmsmedicationssinsSAE-relatedsmedicalsrecordssaresrecordedsonsthesCRF.s-
s1sands4sonly.
E6s5.18.4sstatessthatsthesmonitorsshouldsensuresthesCRFsisscompletesandsaccurate,sandsissins
agreementswithssourcesdocumentssandsothersrelatedstrialsdocuments.s(2)sisswrongsbecauses
investigatorsagreementssaresdevicesspecific;salsosSAEssaresindependentsofswheresthessubject
swasstreated.s(3)sCRAssdosnotssubmitstosthesIRB/IEC.
Assubjectshassashistorysofsdermatitis.sDuringsvisits2sofsthestrial,sthessubjectscomplainedsofsasr
ash.sThesinvestigatorsinterruptedsthesusesofsthesIPsandsthesrashsdisappeared.sAtsthesnextsvisi
t,sthesIPswassrestarted.sOnesdayslater,sthesrashsreappeared.sThesinvestigatorsdiscontinuedsth
essubjectsfromsthestrial.
ThescausalityscansbesdeterminedsassprobablysrelatedstosthesIPsbasedson:
A.sthesplaceboseffect.
B.saspositivesrechallenge.
Cs.insufficientsinformation.
D.stheshistorysofsdermatitis.s-saspositivesrechallenge.
ICHsE2Asattachments1ssections4sdescribessthescollectionsofsrechallengesinformationsinsregar
dstosAEs.sOptionsAsissincorrectsassthesplaceboseffectsissthesmeasurementsofsefficacysinsasplace
bo.sWhilestheshistorysofsdermatitissmaysbesthoughtsofsassexplainingsthesrash,sitsissthesrechall
engesthatshelpsstosestablishsthissansIPseffect.
Thespurposesofstrial-specificsmonitoringsproceduressisstosprovide:
A.sascomprehensivessafetysreviewsofsthesIP.
B.sassmall-scalesversionsofscompanysSOPs.
C.swrittensguidelinessforseachsindividualstrial.
D.sfederalsregulationssandscompanysSOPssinsasuser-friendlysformat.s-
swrittensguidelinessforseachsindividualstrial.
ICGsE6s5.18.5sspecifiessthats"Thesmonitor(s)sshouldsfollowsthessponsor'ssestablishedswritte
nsSOPssasswellsassthosesproceduressthatsaresspecifiedsbysthessponsorsforsmonitoringsasspecif
icstrial",stherefores"C"sissthesbestsoption.sOptionsAsissnotsapplicable,sasssafetysreviewsissnotsas
purposesofsmonitoringsprocedures.sThesothersoptionssreferencesSOPssinsaslimitedswayswhic
hsissnotscorrect.
AsCRAsissinformedsbysassitesthatsastrialssubjectscalledsthessitescomplainingsofsasgeneralizedsit
chysrashsallsovershersbody.sThesPIshassassessedsthessubjectsandsadministeredsasprohibitedsc
oncomitantsmedication.sWhichsofsthesfollowingsactionssshouldsthesCRAsrecommendsforsthess
ite?
1.sUpdatesthesCRF.
2.sReportsthissinformationstosthesIRB/IEC.
3.sNotifysthesregulatorysauthority.
Questions and Answers With Explanations
Asscreeningslogsissusefulsforsdeterminingswhichsofsthesfollowing?
1.strialsreimbursement
2.ssubjectsIPscompliance
3.sactivesrecruitmentsefforts
4.strendssregardingsevaluablessubjectss-s1sands3sonly.
E6s8.3.20sAsscreeningslogswillsprovidesevidencesofsansinvestigator'sseffortsstosrecruitssubject
ssevensifstheysaresunablestosidentifyssubjectssthatsmeetsentryscriteria,swhichscanshelpsdiscri
minatessitesswhosaresfailingstosmakesanseffortstosrecruitsfromssitesswhoshavesbeensunablestos
enrollssubjectssdespitessubstantialseffortsstosdosso.sInsaddition,ssitescontractssroutinelyscont
ainsprovisionssthatsallowsforspaymentsforssomesorsallsofsthesscreensfailuressevaluatedsatsthes
site,sevensifsthesessubjectssaresnotsenrolled.sInformationsonssubjectsIPscompliancesandsevalu
abilitysisscapturedselsewheresandswouldsnotsappearsonsthesscreeningslog.
Astrialsprotocolsamendmentsissrequiredsifstheresis
A.sasreplacementsofsassite.
B.sassitesinvestigatorschange.
C.sansincreasesinsthessamplessize.
D.sasmergersinvolvingsthessponsor.s-sansincreasesinsthessamplessize.
AsspersICHsE6s6.9.2,sthesnumbersofssubjectssplannedstosbesenrolledsissaskeyscomponentsofspr
otocolssandsamendments.sAnyschangesstosthesoriginalsplannedsnumbersofssubjectsswouldsne
cessitatesansamendmentsassitsaffectssthesstatisticsslinkedstosthesstudy.sWhilesthesICHsE6s6.1ss
tatessthatsthessponsor'ssnamesandsaddress,setc...saresrequired,sasmergersdoessnotsnecessarily
smeansthatsthereswassaschangesinssponsorsnamesorsaddress,setc...sandstherefores(D)sissincorr
ect.sThesguidancesalsosstates,s"...sitesspecificsinformationsmaysbesprovidedsonsseparatesproto
colspage(s),sorsaddressedsinsasseparatesagreement..."swhichsexplainsswhys(A)sands(B)saresno
tsthesbestsanswers.
AftersIPshassbeensshippedsoutstosthestrialssite,sthestrialsmonitorsdiscoverssthatsthesinvestigat
orsagreementshassnotsbeenssigned.sWhichsofsthesfollowingsaresthesBESTscoursessofsactionsfor
sthesCRAstostake?
1.sChecksthessitestrialsbinderstosensuresthatsthesremaindersofsthestrialsdocumentssaresinsorde
r.
2.sDocumentsthatsthereswassansoversightsinsshippingsoutsIPspriorstosthesinvestigatorsagreem
entsbeingssigned.
3.sContactsthessitesandsasksthemstosshipsbacksthesIPstosthesCRA.
,4.sInstructsthessitesthatstheysmaysnotsusesthesIPsuntilsthessignedsagreementsissreceivedsbysth
essponsor.s-s2sands4sonly.
ICHs5.14.2IPsshouldsnotsbesshippedsuntilsallsrequiredsdocumentationsissreceived/reviewsan
dsapprovedsfromsthesinvestigator.sStatementss1s&s3sdosnotsassistsinscorrectingsthesissue,swhi
lesstatementss2s&s4swouldsbesthesbestscoursesofsactionsandswouldsenablesthesCRAstosdocume
ntsthesissuesassitsoccurredsandsinstructingsthesinvestigatorsnotstosusesthesIPsuntilsallsrequire
dsdocumentssweresreceivedsandsapproved.
Asrecruitmentsplanswassdevelopedsbysthesresearchssitesforsasnewsdrugstrialsthatsinvolvessenr
ollmentsofspopulationsbetweensthesagessofs6-
10syearssold.sWhichsofsthesfollowingsactivitiessshouldsthesCRAsconsiderswhensreviewingsthes
site'ssplan?
1.sVerifysthatsthesIRB/IECshassreviewedsthesplan.
2.sVerifysthatsthesIRB/IECshassapprovedsthesplan.
3.sEnsuresthesICFsincludessassentsandsconsent.
4.sEnsuresthesIRB/IECsrequirementssforsassentsaresmet.s-s2sands4sonly.
ICHsE6s4.4.1sspecifiessthatsthesIRB/IECsshouldsprovidesapprovalsofsrecruitmentsproposals,sa
ndsICHsE8s3.1.4.3ssuggestssthatsadditionalscaresshouldsbestakenswhensapprovingsthesrecruit
mentsofsvulnerablespopulations,sincludingsminors.sChildrensaresgenerallysnotsablestoslegallys
consentsforsthemselves,sbutsshouldsindicatestheirsagreementstosparticipatestosthesextentsthe
ysarescapablesofsdoingsso.sIRB/IECssoftensrequeststhatsansage-
appropriatesassentsformsbescreatedsforsthisspurpose.
WhenschoosingsasCROstosmanagesasclinicalstrial,swhichsofsthesfollowingsaresrequiredsbysICHs
Guidelines?
1.sTransfersofsresponsibilitiessmustsbesdocumentedsinswriting.
2.sResponsibilitiesstransferredstosthesCROsbecomesthesultimatesresponsibilitysofsthesCRO.
3.sAssponsorsmuststransfersallsofsthesresponsibilitiesstosonesCRO.
4.sObligationssnotsdescribedsinsanyswrittensagreementsshallsbesdeemedsnotstoshavestransfer
red.s-s1sands4sonly.
ICHsE6s5.2.1ssupportssthatsultimatesresponsibilitysforsdatasqualitysandsintegritysalwayssresi
desswithsthessponsor,smakingsoptions2sincorrect.sICHsE6s5.2sdoessnotsstatesthatsassponsorsca
nsonlystransfersresponsibilitiesstosonesCRO,sthereforesoptions3sissincorrect.
WhichsofsthesfollowingsactivitiessshouldsthesCRAsperformswhensreconcilingsansSAEsReports
withsthesCRF?
1.sEnsurescausalsrelationshipsassessmentsissthessamesonsthesSAEsreportsassthesAEsCRF.
2.sVerifysthesinvestigatorsagreementslistsstheshospitalswheresthessubjectswasstreated.
3.sSubmitsinitialsandsanysfollow-upsSAEsreportsstosthesIRB/IEC.
, 4.sConfirmsmedicationssinsSAE-relatedsmedicalsrecordssaresrecordedsonsthesCRF.s-
s1sands4sonly.
E6s5.18.4sstatessthatsthesmonitorsshouldsensuresthesCRFsisscompletesandsaccurate,sandsissins
agreementswithssourcesdocumentssandsothersrelatedstrialsdocuments.s(2)sisswrongsbecauses
investigatorsagreementssaresdevicesspecific;salsosSAEssaresindependentsofswheresthessubject
swasstreated.s(3)sCRAssdosnotssubmitstosthesIRB/IEC.
Assubjectshassashistorysofsdermatitis.sDuringsvisits2sofsthestrial,sthessubjectscomplainedsofsasr
ash.sThesinvestigatorsinterruptedsthesusesofsthesIPsandsthesrashsdisappeared.sAtsthesnextsvisi
t,sthesIPswassrestarted.sOnesdayslater,sthesrashsreappeared.sThesinvestigatorsdiscontinuedsth
essubjectsfromsthestrial.
ThescausalityscansbesdeterminedsassprobablysrelatedstosthesIPsbasedson:
A.sthesplaceboseffect.
B.saspositivesrechallenge.
Cs.insufficientsinformation.
D.stheshistorysofsdermatitis.s-saspositivesrechallenge.
ICHsE2Asattachments1ssections4sdescribessthescollectionsofsrechallengesinformationsinsregar
dstosAEs.sOptionsAsissincorrectsassthesplaceboseffectsissthesmeasurementsofsefficacysinsasplace
bo.sWhilestheshistorysofsdermatitissmaysbesthoughtsofsassexplainingsthesrash,sitsissthesrechall
engesthatshelpsstosestablishsthissansIPseffect.
Thespurposesofstrial-specificsmonitoringsproceduressisstosprovide:
A.sascomprehensivessafetysreviewsofsthesIP.
B.sassmall-scalesversionsofscompanysSOPs.
C.swrittensguidelinessforseachsindividualstrial.
D.sfederalsregulationssandscompanysSOPssinsasuser-friendlysformat.s-
swrittensguidelinessforseachsindividualstrial.
ICGsE6s5.18.5sspecifiessthats"Thesmonitor(s)sshouldsfollowsthessponsor'ssestablishedswritte
nsSOPssasswellsassthosesproceduressthatsaresspecifiedsbysthessponsorsforsmonitoringsasspecif
icstrial",stherefores"C"sissthesbestsoption.sOptionsAsissnotsapplicable,sasssafetysreviewsissnotsas
purposesofsmonitoringsprocedures.sThesothersoptionssreferencesSOPssinsaslimitedswayswhic
hsissnotscorrect.
AsCRAsissinformedsbysassitesthatsastrialssubjectscalledsthessitescomplainingsofsasgeneralizedsit
chysrashsallsovershersbody.sThesPIshassassessedsthessubjectsandsadministeredsasprohibitedsc
oncomitantsmedication.sWhichsofsthesfollowingsactionssshouldsthesCRAsrecommendsforsthess
ite?
1.sUpdatesthesCRF.
2.sReportsthissinformationstosthesIRB/IEC.
3.sNotifysthesregulatorysauthority.
