ACRP CCRC EXAM PREP QUESTIONS AND CORRECT AN
g g g g g g g
SWERS
1. Whatgaregexpectedgorgpossiblegconsequencesgofgover-
g estimationgofgrecruit-gmentgpotential?:g-
Thegtrialgwillgoverrungitsgprojectedgtimeline
g
- Thegrecruitmentgperiodgwillgbegprolongedgandgmoregsitesgmaygbegn
eeded
- Thegstudygwillgnotghavegsufficientgdatagwithingthegrequiredgtimeframega
ndgwillgbegstoppedgbecausegofglackgofgbudget
2. Whatgshouldgbegthegfirstgconsiderationgwhengconductinggag
clinicalgtrial?:g-
Subjectgwelfare
3. Whengisgtheginvestigatorgallowedgtogdeviategfromgtheg
protocol?:gWhengtheregisgangimmediateghazardgtogagpatient.
4. Ifgtheginvestigatorgwantedgtogdeviategfromgthegprotocolgforg
angimmediateghazardgtogagpatient,gaccordinggtogICHgE6gguide
linesgwhogworldgtheygneedgtogreportgthegdeviationgand
,rationalegto,gifgappropriate?:g-gThegSponsor
- IRB/IEC
- RegulatorygAuthorities
5. Whichgconditionsgshouldgbegfulfilledgwhengenrollinggags
ubjectgintogyourgtrial?:g-gSubjectgmeetsgallginclusiongcriteria
- Subjectghasggivengwrittenginformedgconsent
6. You'vegbeengdelegatedgtoghandlegthegstoragegandginventorygofg
IP.Thegstudygdruggmustgbegstoredgbelowg25C/77F.gOngagsumme
rgMondaygmorninggyougdiscovergthatgthegtemperaturegrecordin
ggmachinegingthegstoragegroomghasgfailedgsogyougdoin'tgknowgw
hatgthegtemperatureghasgbeengovergthegweekend.gYougcheckgth
egcurrentgtemperature;git'sg24C/75F.gWhatgshouldgyougdo?:g-
ContactgthegSponsor,gexplaingwhatghappenedgandgaskgforginstructions
g
- Setgupgagsitegstaffgmeetinggtogconductgagrootgcauseganalysis
7. Agprotocolgamendmentgwasgissuedgforgagtrial.gYourgsitegrec
eivedgIRBgapprovalgforgthegamendmentgandgwantsgtogimple
mentgthegincreasegingPOgdosegforgyourgtrialgsubjectsgasgidenti
fiedgingthegamendmentgtrialgsubjects.gAsgdelegated
,consentinggdutiesgyougmustgre-
consentgtrialgsubjectsgbeforegbeinggablegtogadministergthegadju
stedgdose.gYougdecidegtogonlygre-
consentgtrialgsubjectsgwhogaregstillgtakinggthegIPgandgnotgfromgt
hegsubjectsgwohgalreadygcompletedgtheirgdruggintakegperiod.gIs
thisgallowedgaccordinggthegE6gGuidelinegforgGCP?:gNo,gthesegsubj
g
ectsgaregstillgenrolledgingthegtrialgandgthereforegneedgtogbegupdatedgonga
nygchangesgtogthegprotocol.
8. Agtrialgsubjectginformsgyougshegnoglongergwantsgtogparticipantg
ingthegtrial.gWhatgshouldgyourgcoursegofgactiongbe?:gYougaskgifgtheg
patientgwishesgtogsharegthegreasongwhygshegwantsgtogleavegthegtrial.gIfgn
ot,gyougexcludegthegsubjectgfromgthegtrialgimmediately.
1g/g26
, ACRP CCRC EXAM PREP QUESTIONS AND CORRECT AN
g g g g g g g
SWERS
9. Agpatientgcannotgrecallgthegnamegofgthegheartgconditiongmedic
ationghegtookgagfewgyearsgago.gThisgisgimportantginformationgforg
decidinggwhethergthegpatientgmaygbegenrolledgingagclinicalgtrialg(
IC/EC).gWhat'sgyourgbestgcoursegofgaction?:gYougattemptgtogretriev
egthegpatientsgmedicalghistorygbygcontactinggpreviousgcaregiversgandgyoug
waitgforgadditionalginformationgbeforegenrollment.
10. Whoghasgultimategtrialgresponsibilitygforgeachgsubject?:gTheg
principlegin-gvestigator.
11. Agtrialgsubjectgsuffersgfromgseveregrepeatgheadaches.gShouldg
thisgadversegeventgbegreportedgtogthegIRB?:gNo
12. Whatgstatementsgaregtruegconcerninggangadversegdruggrea
ction?:g-
Allgnoxiousgandgunintendedgresponsesgtogagmedicinalgproductgrelatedg
g
toganygdosegshouldgbegconsideredgasgangADR
- AngADRgsuggestsgagrelationshipgtogtrailgmedication
g g g g g g g
SWERS
1. Whatgaregexpectedgorgpossiblegconsequencesgofgover-
g estimationgofgrecruit-gmentgpotential?:g-
Thegtrialgwillgoverrungitsgprojectedgtimeline
g
- Thegrecruitmentgperiodgwillgbegprolongedgandgmoregsitesgmaygbegn
eeded
- Thegstudygwillgnotghavegsufficientgdatagwithingthegrequiredgtimeframega
ndgwillgbegstoppedgbecausegofglackgofgbudget
2. Whatgshouldgbegthegfirstgconsiderationgwhengconductinggag
clinicalgtrial?:g-
Subjectgwelfare
3. Whengisgtheginvestigatorgallowedgtogdeviategfromgtheg
protocol?:gWhengtheregisgangimmediateghazardgtogagpatient.
4. Ifgtheginvestigatorgwantedgtogdeviategfromgthegprotocolgforg
angimmediateghazardgtogagpatient,gaccordinggtogICHgE6gguide
linesgwhogworldgtheygneedgtogreportgthegdeviationgand
,rationalegto,gifgappropriate?:g-gThegSponsor
- IRB/IEC
- RegulatorygAuthorities
5. Whichgconditionsgshouldgbegfulfilledgwhengenrollinggags
ubjectgintogyourgtrial?:g-gSubjectgmeetsgallginclusiongcriteria
- Subjectghasggivengwrittenginformedgconsent
6. You'vegbeengdelegatedgtoghandlegthegstoragegandginventorygofg
IP.Thegstudygdruggmustgbegstoredgbelowg25C/77F.gOngagsumme
rgMondaygmorninggyougdiscovergthatgthegtemperaturegrecordin
ggmachinegingthegstoragegroomghasgfailedgsogyougdoin'tgknowgw
hatgthegtemperatureghasgbeengovergthegweekend.gYougcheckgth
egcurrentgtemperature;git'sg24C/75F.gWhatgshouldgyougdo?:g-
ContactgthegSponsor,gexplaingwhatghappenedgandgaskgforginstructions
g
- Setgupgagsitegstaffgmeetinggtogconductgagrootgcauseganalysis
7. Agprotocolgamendmentgwasgissuedgforgagtrial.gYourgsitegrec
eivedgIRBgapprovalgforgthegamendmentgandgwantsgtogimple
mentgthegincreasegingPOgdosegforgyourgtrialgsubjectsgasgidenti
fiedgingthegamendmentgtrialgsubjects.gAsgdelegated
,consentinggdutiesgyougmustgre-
consentgtrialgsubjectsgbeforegbeinggablegtogadministergthegadju
stedgdose.gYougdecidegtogonlygre-
consentgtrialgsubjectsgwhogaregstillgtakinggthegIPgandgnotgfromgt
hegsubjectsgwohgalreadygcompletedgtheirgdruggintakegperiod.gIs
thisgallowedgaccordinggthegE6gGuidelinegforgGCP?:gNo,gthesegsubj
g
ectsgaregstillgenrolledgingthegtrialgandgthereforegneedgtogbegupdatedgonga
nygchangesgtogthegprotocol.
8. Agtrialgsubjectginformsgyougshegnoglongergwantsgtogparticipantg
ingthegtrial.gWhatgshouldgyourgcoursegofgactiongbe?:gYougaskgifgtheg
patientgwishesgtogsharegthegreasongwhygshegwantsgtogleavegthegtrial.gIfgn
ot,gyougexcludegthegsubjectgfromgthegtrialgimmediately.
1g/g26
, ACRP CCRC EXAM PREP QUESTIONS AND CORRECT AN
g g g g g g g
SWERS
9. Agpatientgcannotgrecallgthegnamegofgthegheartgconditiongmedic
ationghegtookgagfewgyearsgago.gThisgisgimportantginformationgforg
decidinggwhethergthegpatientgmaygbegenrolledgingagclinicalgtrialg(
IC/EC).gWhat'sgyourgbestgcoursegofgaction?:gYougattemptgtogretriev
egthegpatientsgmedicalghistorygbygcontactinggpreviousgcaregiversgandgyoug
waitgforgadditionalginformationgbeforegenrollment.
10. Whoghasgultimategtrialgresponsibilitygforgeachgsubject?:gTheg
principlegin-gvestigator.
11. Agtrialgsubjectgsuffersgfromgseveregrepeatgheadaches.gShouldg
thisgadversegeventgbegreportedgtogthegIRB?:gNo
12. Whatgstatementsgaregtruegconcerninggangadversegdruggrea
ction?:g-
Allgnoxiousgandgunintendedgresponsesgtogagmedicinalgproductgrelatedg
g
toganygdosegshouldgbegconsideredgasgangADR
- AngADRgsuggestsgagrelationshipgtogtrailgmedication
