ACRPg-gCCRCgExamgPrepg(Question)
1. AngAdversegeventgisgdefinedgasgonegwhich?
a. Resultsginghospitalization
b. Causesgagdisability
c. Isgnotgnecessarilygcausallygrelatedgtogdrug
d. Isglifegthreatening
2. Agresponsegtogagmedicalgproductgmeansg(CheckgallgthatgApply)
a. Agcasualgrelationshipgbetweengdruggandgadversegeventgisgestablished
b. Agcasualgrelationshipgbetweengdruggandgadversegeventgisgagreasonab
legpossibility
c. Thegrelationshipgofgthegeventgtogdruggcannotgbegruledgout
d. Angeventgthatgrequiresgactivegmedicalgintervention
3. ForgagdruggthatgisgingagPhasegIVgtrialgandgadversegdruggreactiongisgonegwhich
a. Isgnoxiousgandgunintended
b. Occursg atg normalg dosesg usedg forg prophylaxis
c. Agonly
d. AgandgB
4. Thegterm,glifegthreatening,gingagseriousgadversegeventgrefersgto
a. Ang eventg whichg requiredg hospitalization
b. Angeventgwheregriskgofgdeathgwasgevidentgatgthegtimegofgthegevent
c. Angeventgthatgrequiredgtreatmentgingangemergencygroom
d. Angeventgwhichgmightghavegcausedgagdeathgifgleftguntreated
5. Ang eventg mayg beg classifiedg asg seriousg ifg it
a. Notg immediatelyg lifeg threatening,g butg mayg jeopardizeg theg patient
b. Notgimmediatelyglifegthreateninggbutgmaygrequiregandginterventiongto
gpreventghospitalization
c. Agonly
d. AgandgB
6. AgpatientgingagclinicalgIgtrialgforgjointgpaingexperiencesgagbronchospasmgwhileg
atghome.gThegeventgwouldgbe
a. Notgreportablegbecausegitgoccurredgingaghomegsetting
b. Ang adverseg eventg whichg doesg notg requireg reporting
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, c. Angunexpectedgadversegeventgwhichgdoesgnotgrequiregexpedite
dgreporting
d. Maybegconsideredgseriousgandgshouldgbegconsideredgforgexpedite
dgreporting
7. Angunexpectedgadversegreactiongisgonegwhichgis
a. Notgexpectedgbygtheginvestigator
b. Notgmentionedgingtheginvestigator’sgbrochuregorgrelevantgsourc
egdocument
c. Classifiedg asg suchg byg theg IRB
d. Classifiedg asg suchg byg theg sponsor’sg medicalg safetyg officer
8. Forgexpeditedgreportinggangeventg mustg be
a. Serious
b. Seriousgandgunexpected
c. Onlyg temporallyg associatedg withg drugg administration
d. Causallyg relatedg tog drugg administration
9. Accordingg togICHg seriousg unexpectedg reactiong tog ag drugg shouldg be
a. Submittedg tog theg appropriateg regulatoryg authorityg withing oneg week
b. Submittedgtogthegappropriategregulatorygauthoritygwithing15gdays
c. Submittedgtogthegappropriategregulatorygauthoritygongangexpedite
dgbasis
d. Submittedg promptlyg tog theg IRB
10. Clinicalg investigationg ofg adverseg eventsg ing clinicalg trialsg requires
a. Rootgcauseganalysis
b. Completegmedicalgrecordsgreview
c. Investigationgofg potentialg protocolg deviations
d. Informedg consentg process
11. Adverseg eventsg ofg marketedg drugsg usuallyg imply
a. Multi-drugginteractions
b. Unreliableg subjectiveg measures
c. Psychosomaticgfactors
d. Causality
12. Ifgthegpatient'sgweightgisg123glbs,gwhatgisgthegweightgingkg?
a. 31
b. 48
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, c. 56
d. 271
13. Rapidgcommunicationgofgsinglegcasegreportsgofgseriousgadversegeventsgis
gmeritedgifgtheginformation
a. Influencesgriskgbenefitgassessment
b. Impliesgagchangegneedgingdruggadministration
c. Ag changeg ing theg conductg ofg theg clinicalg investigation
d. Allgofgthegabove
14. Expeditedg reportingg ofg seriousg adverseg eventsg mayg beg consideredg if
a. Theregisgangincreasedgrategoccurrencegingthegseriousgadversegdru
ggreaction
b. Aglackgofgefficacygisgevidentgingtreatinggaglife-threatinggdisease
c. Allgofgthegabove
15. Fatalgorglifegthreateninggandgunexpectedgadversegdruggreactionsgingclinicalgi
nvestigationsgshouldgbegreportedgtogthegregulatorygagenciesg(checkgallgthatg
apply)
a. Noglatergthang7gdaysgaftergfirstgknowledgegofgevent
b. Noglatergthang15gdaysgaftergfirstgknowledgegofgevent
c. Bygfilinggagcompletegreportgwithing8gadditionalgdaysgofgtheginiti
algnotification
d. Bygfillinggagcompletegreportgwithing15gadditionalgdaysgofgtheginiti
algnotification
16. Seriousg adverseg drugg reactionsg mustg beg filedg withg regulatoryg agencies
a. Asgsoongasgpossible,gbutgnotglatergthan,g8gdaysgofgfirstgknowledge
b. Asgsoongasgpossible,gbutgnotglatergthan,g10gdaysgofgfirstgknowledge
c. Asgsoongasgpossible,gbutgnotglatergthan,g15gdaysgofgfirstgknowledge
d. Asgsoongasgpossible,gbutgnotglatergthan,g1gmonthgofgfirstgknowledge
17. Ingascertaininggthegbasisgforgagseriousgadversegdruggreactiongingagrandomiz
edgtrial
a. Caregshouldgbegtakengnotgtogbreakgthegblindgforgthegpatient
b. Caregshouldgbegtakengtogbreakgthegblindgonlygforgthegsinglegpatie
ntginvolved
c. Thegblindgforgtheggroupgofgpatientsgbeinggtreatedgatgthegsitegshouldg
begbroken
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, d. Thegblindgforgthegsinglegpatientgshouldgbegbrokengonlygifgthegspons
orgapproves
18. Theg ethicalg principlesg underlyingg clinicalg trialsg areg statedg in
a. Declarationg ofg Helsinki
b. Nurembergg Code
c. 21gCFRg513
d. HarmonizationgCode
19. Pharmacologyg Trialsg are?
a. Phaseg I
b. Phaseg II
c. Phaseg III
d. PhasegIV
20. Therapeuticg Confirmatoryg studiesg areg likely?
a. Phaseg I
b. Phaseg II
c. Phaseg III
d. PhasegIV
21. Drugg absorptiong andg metabolismg are
a. Studiedg ing Phaseg I
b. StudiedgingPhasegIIgifgPhasegIgisginconclusive
c. Throughoutg theg developmentg plan
d. Neverg studiedg ing Phaseg III
22. Safetyg isg ang objectiveg for
a. Phaseg I
b. PhasegI,gII
c. PhasegI,gIII
d. PhasegI,gII,gIII,gIV
23. Studiesgthatgaregforgmarketinggapprovalgisglikelygtogbe
a. Phaseg I
b. Phaseg II
c. Phaseg III
d. PhasegIV
24. Responsegvariablesgaregrelatedgtog(Pickgallgapply)
a. Primaryg objective
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1. AngAdversegeventgisgdefinedgasgonegwhich?
a. Resultsginghospitalization
b. Causesgagdisability
c. Isgnotgnecessarilygcausallygrelatedgtogdrug
d. Isglifegthreatening
2. Agresponsegtogagmedicalgproductgmeansg(CheckgallgthatgApply)
a. Agcasualgrelationshipgbetweengdruggandgadversegeventgisgestablished
b. Agcasualgrelationshipgbetweengdruggandgadversegeventgisgagreasonab
legpossibility
c. Thegrelationshipgofgthegeventgtogdruggcannotgbegruledgout
d. Angeventgthatgrequiresgactivegmedicalgintervention
3. ForgagdruggthatgisgingagPhasegIVgtrialgandgadversegdruggreactiongisgonegwhich
a. Isgnoxiousgandgunintended
b. Occursg atg normalg dosesg usedg forg prophylaxis
c. Agonly
d. AgandgB
4. Thegterm,glifegthreatening,gingagseriousgadversegeventgrefersgto
a. Ang eventg whichg requiredg hospitalization
b. Angeventgwheregriskgofgdeathgwasgevidentgatgthegtimegofgthegevent
c. Angeventgthatgrequiredgtreatmentgingangemergencygroom
d. Angeventgwhichgmightghavegcausedgagdeathgifgleftguntreated
5. Ang eventg mayg beg classifiedg asg seriousg ifg it
a. Notg immediatelyg lifeg threatening,g butg mayg jeopardizeg theg patient
b. Notgimmediatelyglifegthreateninggbutgmaygrequiregandginterventiongto
gpreventghospitalization
c. Agonly
d. AgandgB
6. AgpatientgingagclinicalgIgtrialgforgjointgpaingexperiencesgagbronchospasmgwhileg
atghome.gThegeventgwouldgbe
a. Notgreportablegbecausegitgoccurredgingaghomegsetting
b. Ang adverseg eventg whichg doesg notg requireg reporting
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, c. Angunexpectedgadversegeventgwhichgdoesgnotgrequiregexpedite
dgreporting
d. Maybegconsideredgseriousgandgshouldgbegconsideredgforgexpedite
dgreporting
7. Angunexpectedgadversegreactiongisgonegwhichgis
a. Notgexpectedgbygtheginvestigator
b. Notgmentionedgingtheginvestigator’sgbrochuregorgrelevantgsourc
egdocument
c. Classifiedg asg suchg byg theg IRB
d. Classifiedg asg suchg byg theg sponsor’sg medicalg safetyg officer
8. Forgexpeditedgreportinggangeventg mustg be
a. Serious
b. Seriousgandgunexpected
c. Onlyg temporallyg associatedg withg drugg administration
d. Causallyg relatedg tog drugg administration
9. Accordingg togICHg seriousg unexpectedg reactiong tog ag drugg shouldg be
a. Submittedg tog theg appropriateg regulatoryg authorityg withing oneg week
b. Submittedgtogthegappropriategregulatorygauthoritygwithing15gdays
c. Submittedgtogthegappropriategregulatorygauthoritygongangexpedite
dgbasis
d. Submittedg promptlyg tog theg IRB
10. Clinicalg investigationg ofg adverseg eventsg ing clinicalg trialsg requires
a. Rootgcauseganalysis
b. Completegmedicalgrecordsgreview
c. Investigationgofg potentialg protocolg deviations
d. Informedg consentg process
11. Adverseg eventsg ofg marketedg drugsg usuallyg imply
a. Multi-drugginteractions
b. Unreliableg subjectiveg measures
c. Psychosomaticgfactors
d. Causality
12. Ifgthegpatient'sgweightgisg123glbs,gwhatgisgthegweightgingkg?
a. 31
b. 48
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, c. 56
d. 271
13. Rapidgcommunicationgofgsinglegcasegreportsgofgseriousgadversegeventsgis
gmeritedgifgtheginformation
a. Influencesgriskgbenefitgassessment
b. Impliesgagchangegneedgingdruggadministration
c. Ag changeg ing theg conductg ofg theg clinicalg investigation
d. Allgofgthegabove
14. Expeditedg reportingg ofg seriousg adverseg eventsg mayg beg consideredg if
a. Theregisgangincreasedgrategoccurrencegingthegseriousgadversegdru
ggreaction
b. Aglackgofgefficacygisgevidentgingtreatinggaglife-threatinggdisease
c. Allgofgthegabove
15. Fatalgorglifegthreateninggandgunexpectedgadversegdruggreactionsgingclinicalgi
nvestigationsgshouldgbegreportedgtogthegregulatorygagenciesg(checkgallgthatg
apply)
a. Noglatergthang7gdaysgaftergfirstgknowledgegofgevent
b. Noglatergthang15gdaysgaftergfirstgknowledgegofgevent
c. Bygfilinggagcompletegreportgwithing8gadditionalgdaysgofgtheginiti
algnotification
d. Bygfillinggagcompletegreportgwithing15gadditionalgdaysgofgtheginiti
algnotification
16. Seriousg adverseg drugg reactionsg mustg beg filedg withg regulatoryg agencies
a. Asgsoongasgpossible,gbutgnotglatergthan,g8gdaysgofgfirstgknowledge
b. Asgsoongasgpossible,gbutgnotglatergthan,g10gdaysgofgfirstgknowledge
c. Asgsoongasgpossible,gbutgnotglatergthan,g15gdaysgofgfirstgknowledge
d. Asgsoongasgpossible,gbutgnotglatergthan,g1gmonthgofgfirstgknowledge
17. Ingascertaininggthegbasisgforgagseriousgadversegdruggreactiongingagrandomiz
edgtrial
a. Caregshouldgbegtakengnotgtogbreakgthegblindgforgthegpatient
b. Caregshouldgbegtakengtogbreakgthegblindgonlygforgthegsinglegpatie
ntginvolved
c. Thegblindgforgtheggroupgofgpatientsgbeinggtreatedgatgthegsitegshouldg
begbroken
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, d. Thegblindgforgthegsinglegpatientgshouldgbegbrokengonlygifgthegspons
orgapproves
18. Theg ethicalg principlesg underlyingg clinicalg trialsg areg statedg in
a. Declarationg ofg Helsinki
b. Nurembergg Code
c. 21gCFRg513
d. HarmonizationgCode
19. Pharmacologyg Trialsg are?
a. Phaseg I
b. Phaseg II
c. Phaseg III
d. PhasegIV
20. Therapeuticg Confirmatoryg studiesg areg likely?
a. Phaseg I
b. Phaseg II
c. Phaseg III
d. PhasegIV
21. Drugg absorptiong andg metabolismg are
a. Studiedg ing Phaseg I
b. StudiedgingPhasegIIgifgPhasegIgisginconclusive
c. Throughoutg theg developmentg plan
d. Neverg studiedg ing Phaseg III
22. Safetyg isg ang objectiveg for
a. Phaseg I
b. PhasegI,gII
c. PhasegI,gIII
d. PhasegI,gII,gIII,gIV
23. Studiesgthatgaregforgmarketinggapprovalgisglikelygtogbe
a. Phaseg I
b. Phaseg II
c. Phaseg III
d. PhasegIV
24. Responsegvariablesgaregrelatedgtog(Pickgallgapply)
a. Primaryg objective
Version:gDJ1.0gMadegby:gDeangJangg
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