2025年crc英文考試題及答案

Section1:MultipleChoiceQuestions(20items,2pointseach)

1.AccordingtoICH-GCPE6(R3),whichofthefollowingisamandatoryrequirementforinformedconsentdocumentation?

A.Thesubjectsignstheconsentformbeforeverbalexplanation

B.Theconsentformincludesawaiveroflegalliability

C.Acopyofthesignedconsentformisprovidedtothesubject

D.Theprincipalinvestigator(PI)signstheconsentformasawitness

2.Whenpreparingforanewclinicaltrial,theCRCmustverifythattheinvestigationalproduct(IP)isstoredaccordingto:

A.Thesponsor’smarketingdepartmentguidelines

B.Thetemperaturerangespecifiedinthetrialprotocol

C.Localpharmacyinventorymanagementpolicies

D.ThePI’spersonalpreference

3.Asubjectreportsaheadache(painscale3/10)thatstarts2hoursaftertakingtheIPandresolveswithoutintervention4hourslater.Thisshouldberecordedas:

A.Aseriousadverseevent(SAE)

B.Anon-seriousadverseevent(AE)

C.Asuspectedunexpectedseriousadversereaction(SUSAR)

D.Noadverseevent(noactionrequired)

4.Whichofthefollowingisanexampleofsourcedata?

A.AsummaryoflabresultsintheCRF

B.Theoriginalelectrocardiogram(ECG)printout

C.Anoteinthetrialdatabaseaboutamissedvisit

D.Averbalreportofsymptomstothestudynurse

5.Duringamonitoringvisit,themonitoridentifiesadiscrepancybetweentheCRFandsourcedata.TheCRC’sfirstactionshouldbe:

A.CorrecttheCRFwithoutdocumentingthechange

B.DiscussthediscrepancywiththePItoconfirmaccuracy

C.Blamethedataentryclerkfortheerror

D.Ignorethefindingasminor

6.Foratrialinvolvingpediatricsubjects,theCRCmustensurethat:

A.Parental/legalrepresentativeconsentisobtainedinadditiontoassent(ifapplicable)

B.Thesubject’sschoolteachersignstheconsentform

C.Consentiswaivedduetothesubject’sage

D.Onlythesubject’sverbalagreementisrequired

7.Theprimarypurposeofatrialprotocolisto:

A.Providemarketingmaterialsforthesponsor

B.Outlinethestatisticalmethodsfordataanalysis

C.Definethescientificandethicalplanforthetrial

D.Listthesalariesoftheresearchteam

8.Asubjectwithdrawsconsenttoparticipateinthetrial.TheCRCshould:

A.Destroyalldatarelatedtothesubjectimmediately

B.Continuecollectingdatawithoutthesubject’sknowledge

C.Documentthewithdrawalinthesourcerecordsandinformthesponsor

D.Convincethesubjecttostaybyemphasizingtrialbenefits

9.WhichregulatorydocumentoutlinestherequirementsforgoodclinicalpracticeintheEuropeanUnion?

A.21CFRPart11

B.ICH-GCPE6(R3)

C.GMPGuidelines

D.HIPAA

10.WhentranscribingdatafromsourcedocumentstotheCRF,theCRCshould:

A.Roundnumericalvaluestosimplifyrecording

B.Useabbreviationsnotdefinedintheprotocol

C.Copydataexactlyasitappearsinthesource

D.Omitanyabnormalresultstoreducemonitorqueries

11.ASUSARmustbereportedtotheethicscommittee(EC)within:

A.24hoursofthesponsor’sknowledge

B.7daysofinitialreport,withfollow-upwithin8days

C.30daysoftheeventonset

D.Nomandatorytimelinefornon-seriousevents

12.TheCRC’sroleinmaintainingtrialintegrityincludes:

A.Alteringdatatomeetenrollmenttargets

B.EnsuringallsubjectsreceivetheIPasperprotocol

C.Hidingprotocoldeviationsfrommonitors

D.Sharingsubjectidentifierswithunrelatedresearchers

13.Foratrialusinganelectronicdatacapture(EDC)system,theCRCshould:

A.Accessthesystemusinganotheruser’slogincredentials

B.Documentalldatacorrectionswithanaudittrail

C.Overwriteoriginalentrieswithoutexplanation

D.Exportrawdatatopersonaldevicesforbackup

14.Whichofthefollowingisakeycomponentofatrialmasterfile(TMF)?

A.ThePI’spersonalbankstatements

B.Signedinformedconsentforms

C.Coffeeshopreceiptsfromteammeetings

D.Thesponsor’sinternalmemosunrelatedtothetrial

15.Asubjectasksabouttherisksofthetrial.TheCRCshould:

A.Provideasimplifiedversionoftheconsentform,omittingrisks

B.ReferthesubjecttothePIfordetaileddiscussion

C.Explainrisksbasedontheprotocolandconsentform

D.Avoidansweringtopreventdiscouragingparticipation

16.Toensurecompliancewithdataprivacyregulations(e.g.,GDPR),theCRCmust:

A.Sharesubjectdatawithanyresearcherrequestingit

B.Storepaperrecordsinunlockedcabinets

C.Anonymizedatabeforesharingwiththirdparties

D.Retainsubjectidentifiersindefinitely

17.AprotocoldeviationoccurswhenasubjectreceivestheIP30minutesearlierthanscheduled.TheCRCshould:

A.Pretendthedeviationdidnothappen

B.Documentthedeviation,assessitsimpact,andinformthesponsor

C.Modifythesourcerecordstoshowthecorrectadministrationtime

D.Blamethesubjectfortheerror

18.Theprimaryendpointofatrialisdefinedas:

A.Thenumberofsubjectsenrolled

B.Thekeyoutcomemeasureusedtoevaluatetheintervention

C.Thetotalcostofthetrial

D.ThenumberofAEsreported

19.Duringasiteinitiationvisit(SIV),themonitorverifiesthat:

A.Thesitehassufficientstaffandequipmenttoconductthetrial

B.TheCRChascompletedacookingcourse

C.ThePI’sfavoritecolormatchesthetrial’sbranding

D.Thewaitingroomhasnewfurniture

20.Asubjectlosesfollow-upafterthefirstvisit.TheCRCshould:

A.Assumethesubjectwithdrewandclosetheircase

B.Attempttocontactthesubjectusingallavailablemethods

C.Recordthesubjectas“l(fā)osttofollow-up”withoutdocumentation

D.Deletethesubject’sdatafromthesystem

Section2:MultipleSelectQuestions(10items,3pointseach,selectallthatapply)

21.CoreprinciplesofICH-GCPinclude:

A.Protectionofsubjectrights,safety,andwell-being

B.Scientificvalidityofthetrialdesign

C.Maximizingsponsorprofits

D.Accurateandreliabletrialdata

22.Componentsofavalidinformedconsentprocessinclude:

A.Voluntaryparticipationwithoutcoercion

B.Subjectunderstandingofkeytrialinformation

C.Provisionofawrittenconsentforminthesubject’slanguage

D.Immediatepaymenttothesubjectforsigning

23.ResponsibilitiesoftheCRCduringsubjectenrollmentinclude:

A.Screeningpotentialsubjectsagainstinclusion/exclusioncriteria

B.Explainingthetrialtosubjectsandobtainingconsent

C.AdministeringtheIPwithoutPIoversight

D.Documentingscreeningresultsinsourcerecords

24.Whenhandlinginvestigationalproducts,theCRCmust:

A.StoreIPsinalocked,securelocation

B.TrackIPsusingalogwithdates,quantities,andlotnumbers

C.UseexpiredIPsifnoothersupplyisavailable

D.ReturnunusedIPstothesponsorasperprotocol

25.Examplesofsourcedocumentsinclude:

A.Clinicvisitnotes

B.Laboratoryreports

C.CRFprintouts

D.Subjectdiaries

26.ActionsrequiredforSAEreportinginclude:

A.Immediateverbalnotificationtothesponsor

B.Submissionofawrittenreportwithin24hours(forfatal/life-threateningcases)

C.DocumentationoftheeventinsourcerecordsandCRF

D.HidingtheeventfromtheECtoavoiddelays

27.Measurestoensuredataaccuracyinclude:

A.Regularsourcedataverification(SDV)bytheCRC

B.Double-checkingdataentriesfortranscriptionerrors

C.UsingcorrectionfluidtoerasemistakesinpaperCRFs

D.Maintaininganaudittrailforelectronicdatachanges

28.Ethicalconsiderationsinclinicaltrialsinclude:

A.Ensuringsubjectconfidentiality

B.Avoidingexploitationofvulnerablepopulations

C.Prioritizingtrialenrollmentoversubjectsafety

D.ObtainingindependentECreview

29.TheCRCshouldreportprotocoldeviationsto:

A.ThePI

B.Thesponsor

C.TheEC(ifsignificant)

D.Thesubject’sfamilymembers

30.BestpracticesformaintainingtheTMFinclude:

A.Storingdocumentsinacentralized,organizedsystem

B.BackingupelectronicTMFsregularly

C.AllowinganystaffmembertoeditTMFdocuments

D.Labelingdocumentswithclear,consistentnamingconventions

Section3:CaseAnalysis(5items,10pointseach)

Case1

A55-year-oldsubjectinaPhaseIIIoncologytrialreportschestpain,shortnessofbreath,anddizziness1hourafterreceivingtheinvestigationaldrug.Thesubject’sbloodpressureis80/50mmHg(baseline:120/80mmHg).ThePIdiagnosesasuspectedmyocardialinfarction(MI).

Whattypeofeventisthis?

OutlinethestepstheCRCshouldtakeimmediately.

Case2

Duringaroutinemonitorvisit,themonitoridentifiesthat10CRFentriesforlabvaluesaremissingthesourcedocumentreferences.TheCRCchecksandfindsthesourcelabreportsarefiledinthesubject’schartbutwerenotcross-referencedintheCRF.

Whatistheprimaryissuehere?

HowshouldtheCRCresolvethis?

Case3

Asubjectwithlimitedliteracyrequeststoparticipateinatrial.Thesubjectcannotreadtheconsentformbutunderstandsthetrial’spurpose,risks,andbenefitsafteraverbalexplanationbytheCRC.

Isthesubjecteligibletoprovideinformedconsent?

WhatadditionalstepsshouldtheCRCtaketoensurecompliancewithGCP?

Case4

Thetrialprotocolrequiressubjectstofastfor8hoursbeforeafastingglucosetest.Asubjectarrivesfortheirvisithavingeatenasmallbreakfast2hoursprior.TheCRCnotesthisinthesourcerecordsbutproceedswiththetestasthesubjectinsistsoncontinuing.

Isthisaprotocoldeviation?Whyorwhynot?

WhatshouldtheCRCdonext?

Case5

TheECrequestsanamendmenttothetrialprotocoltoaddanewsafetyparameter.TheamendmentisapprovedbytheECandthesponsor.

WhatactionsmusttheCRCtaketoimplementtheamendment?

Howshouldexistingsubjectsbeinformed?

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Answers

Section1

1.C

2.B

3.B

4.B

5.B

6.A

7.C

8.C

9.B

10.C

11.B

12.B

13.B

14.B

15.C

16.C

17.B

18.B

19.A

20.B

Section2

21.A,B,D

22.A,B,C

23.A,B,D

24.A,B,D

25.A,B,D

26.A,B,C

27.A,B,D

28.A,B,D

29.A,B,C

30.A,B,D

Section3

Case1

Thisisaseriousadverseevent(SAE)duetoitslife-threateningnature(hypotension,suspectedMI).

Steps:ImmediatelyinformthePI;documenttheeventinsourcerecords(time,symptoms,vitalsigns,PI’sassessment);notifythesponsorverballywithin24hours;submitawrittenSAEreporttothesponsorandECwithin24hours(forfatal/life-threateningcases)or7dayswithfollow-upwithin8days;monitorthesubject’sconditionandupdatereportsasneeded.

Case2

Primaryissue:MissingsourcedocumentreferencesinCRFentries,whichcompromisesdatatraceabilityandcompliancewithGCP(sourcedatamustbeverifiable).

Resolution:Cross-referencetheCRFentrieswiththesourcelabreportsbyaddingpagenumbersoridentifiersintheCRF;documentthecorrectionwiththedate,initials,andreason(e.g.,“Sourcereferenceaddedpermonitorquery”);reviewwiththePIforconfirmation;informthemonitorofthecorrection.

Case3

Eligibility:Yes,aslongasthesubjectdemonstratesunderstanding(GCPallowsfornon-literatesubjectsiftheycomprehendthetrialdetails).

Additionalsteps:Useawitness(e.g.,aneutralthirdparty)toattestthat