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CCRP Exam Questions And Answers 100% Verified.
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CCRP Exam Questions And Answers 100% Verified.
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CCRP Exam Questions And Answers 100%Verified.
How xmany xdays xdoes xa xsponsor xhave xto xreport xan xemergency xuse xof xan xIP xto xthe
xFDA? x- xcorrect xanswer. x x x x5 xworking xdays
How xmany xmembers xmust xsit xon xan xIRB? x- xcorrect xanswer. x x x x5
How xlong xmust xan xIRB xretain xrecords xper x21 xCFR x56? x- xcorrect xanswer. x x x x3 xyears
xafter xcompletion xof xresearch
What xare xthe xcriteria xfor xIRB xapproval xof xresearch? x(7) x- xcorrect xanswer. x x x x1. xRisks xto
xsubjects xare xminimized
2. xRisks xare xreasonable xin xrelation xto xanticipated xbenefits
3. xSelection xof xsubjects xis xequitable
4. xInformed xconsent xwill xbe xsought xfrom xsubjects xor xLARs x
5. xInformed xconsent xwill xbe xdocumented
6. xThere xis xadequate xprovision xof xmonitoring
7. xThere xis xadequate xprovision xto xprotect xthe xprivacy xof xsubjects
How xmany xdays xdoes xan xIRB xhave xto xreport xa xchange xin xregistration xinformation xdue xto
xa xchange xin xchairperson xor xcontact? x- xcorrect xanswer. x x x x90 xdays
How xmany xdays xdoes xan xIRB xhave xto xinform xthe xFDA xthat xit xis xreviewing xdifferent xtypes
xof xFDA xproducts? x- xcorrect xanswer. x x x x30 xdays
How xoften xmust xan xIRB xrenew xit's xregistration? x- xcorrect xanswer. x x x x3 xyears
What xare xthe x8 xbasic xelements xof xinformed xconsent xper xFDA xguidelines? x- xcorrect
xanswer. x x x x1. xStatement xthat xthe xstudy xinvolves xresearch, xpurpose xand xexpected
xduration, xdescription xof xexperimental xprocedures
2. xDescription xof xreasonably xforeseeable xrisks
3. xBenefits
4. xDisclosure xof xalternative xprocedures xor xcourses xof xtreatment
5. xConfidentiality xmeasures
,6. xCompensation xand xtreatments xavailable xif xinjury xoccurs x
7. xcontact xinformation
8. xParticipation xis xvoluntary xand xsubject xmay xdiscontinue xat xany xtime
What xare xthe xcriteria xfor xinvolving xchildren xin xminimal xrisk xresearch? x(2) x- xcorrect
xanswer. x x x x1. xNo xgreater xthan xminimal xrisk
2. xAssent xfrom xkid x+ xconsent xfrom xparent xobtained
What xare xthe xcriteria xfor xinvolving xchildren xin xgreater xthan xminimal xrisk xresearch xwith
xprospect xof xbenefit? x(3) x- xcorrect xanswer. x x x x1. xRisks xare xjustified xby xbenefits
2. xRelation xof xanticipated xbenefit xis xat xleast xas xfavorable xas xthat xpresented xby
xalternative xapproaches
3. xAssent x+ xconsent
What xare xthe xcriteria xfor xinvolving xchildren xin xgreater xthan xminimal xrisk xresearch xwith xno
xdirect xbenefit? x(4) x- xcorrect xanswer. x x x x1. xRisks xare xminor xincrease xover xminimal xrisk
2. xIntervention xpresents xexperiences xthat xare xreasonable xcommensurate xwith xnormal
xmedical xand xliving xsituations
3. xIntervention xis xlikely xto xyield xgeneralizable xknowledge xthat xis xvital
4. xAssent x+ xconsent
Sponsors xmust xreport xSAEs xto xthe xFDA xwithin xhow xmany xdays xof xdiscovering xthe
xevent? x- xcorrect xanswer. x x x x15 xcalendar xdays x(21 xCFR x312.32)
Investigators xmust xreport xSAEs xto xa xsponsor xwithin xhow xmany xdays xof xdiscovering xthe
xevent? x- xcorrect xanswer. x x x xImmediately x(21 xCFR x312.64)
Sponsors xmust xreport xwhat xkind xof xserious xevents xto xthe xFDA xwithin x15 xcalendar xdays?
x(4) x- xcorrect xanswer. x x x x 1) xSerious xand xunexpected xsuspected xadverse xreactions
2) xFindings xfrom xother xstudies xthat xsuggest xa xsignificant xrisk xin xhumans
3) xFindings xfrom xanimal xor xin-vitro xtesting xthat xsuggest xrisks xto xhumans
4) xIncreased xrate xof xoccurrence xof xserious xsuspected xadverse xreactions
Sponsors xmust xsubmit xUnanticipated xAdverse xDevice xEffects xto xthe xFDA xwithin xhow
xmany xdays? x- xcorrect xanswer. x x x x10 xworking xdays x(21 xCFR x812.15)
Investigators xmust xsubmit xUnanticipated xAdverse xDevice xEffects xto xthe xFDA xwithin xhow
xmany xdays? x- xcorrect xanswer. x x x x10 xworking xdays x(21 xCFR x812.15)
When xwas xthe xNuremberg xCode xissued? x- xcorrect xanswer. x x x x1947
What xare xthe x10 xpoints xmade xin xthe xNuremberg xCode? x- xcorrect xanswer. x x x x1)
xVoluntary xinformed xconsent xshould xbe xobtained
2) xResearch xshould xyield xbenefit xto xsociety
3) xResearch xshould xbe xbased xon xanimal xwork
4) xAvoid xunnecessary xsuffering
,5) xDon't xdo xresearch xresulting xin xdeath xor xdisabling xinjury
6) xRisks xshould xbe xjustified xby xbenefits
7) xProper xprep xand xadequate xfacilities xshould xbe xused
8) xConducted xby xscientifically xqualified xpeople
9) xSubject xcan xwithdraw xwhenever
10) xResearchers xcan xend xthe xstudy xif xrisks xare xtoo xgreat
When xwas xthe xDeclaration xof xHelsinki xreleased? x- xcorrect xanswer. x x x x1964
Who xdeveloped xthe xDeclaration xof xHelsinki? x- xcorrect xanswer. x x x xWorld xMedical
xAssociation x(WMA)
What xis xthe xDeclaration xof xHelsinki? x- xcorrect xanswer. x x x xDocument xthat xlaid xout xgeneral
xprinciples xphysicians xshould xfollow xto xconduct xresearch xwith xhumans, xbased xon
xNuremberg xCode. xFirst xeffort xof xmedical xcommunity xto xregulate xitself
When xwas xthe xBelmont xReport xreleased? x- xcorrect xanswer. x x x x1979
Who xcreated xthe xBelmont xReport? x- xcorrect xanswer. x x x xNational xCommission xfor xthe
xProtection xof xHuman xSubjects xof xBiomedical xand xBehavioral xResearch x(at xdirection xof
xNational xResearch xAct x1974)
What xare xthe x3 xprinciples xin xthe xBelmont xReport? x- xcorrect xanswer. x x x x1) xRespect xfor
xPersons: xinformed xconsent xrequired xand xindividuals xwith xdiminished xautonomy xget
xspecial xprotections
2) xBeneficence: xmaximize xbenefit xto xresearch xwhile xminimizing xrisk xto xsubjects
3) xJustice: xone xgroup xof xpeople xshouldn't xassume xrisks xfor xthe xbenefit xof xanother
x(equality xand xdiversity xof xparticipants)
In xwhat xorder xwere xhistorical xdeclarations xfor xhuman xsubjects xprotection xreleased? x-
xcorrect xanswer. x x x xNuremberg xCode x> xDeclaration xof xHelsinki x> xBelmont xReport
At xwhat xreading xlevel xshould xICFs xbe xwritten? x- xcorrect xanswer. x x x x6th-8th xgrade
What xFDA xguideline xlists xthe xbasic xelements xof xinformed xconsent? x- xcorrect xanswer. x x x
x21 xCFR x50 x(50.25)
What xare xthe xadditional xelements xof xinformed xconsent xper xFDA xguidelines? x(7) x-
xcorrect xanswer. x x x x1) xStatement xthat xtreatment xmay xinvolve xunforseeable xrisks
2) xCircumstances xin xwhich xsubject xparticipation xmay xbe xterminated
3) xAdditional xcosts xto xsubject
4) xConsequences xof xsubject's xdecision xto xwithdraw
5) xStatement xthat xnew xfindings xwill xbe xprovided xto xsubject
6) x# xof xsubjects xin xstudy
7) xclinicaltrials.gov xstatement x(as xapplicable)
, Who xultimately xapproves xan xICF? x- xcorrect xanswer. x x x xIRB x- xsponsor xcan xprovide
xsample xform
Describe xthe x2 xmost ximportant xpoints xto xconsider xwhen xconsenting xpatients x(per x21
xCFR x50) x- xcorrect xanswer. x x x x1) xNo xperson xcan xparticipate xwithout xtheir xor xLAR
xconsent x(50.20)
2) xDocumentation xof xinformed xconsent xis xrequired x(50.27)
What xare xthe x4 xcomponents xof xthe xconsent xprocess xusing xa xshort xform? x- xcorrect
xanswer. x x x x1) xShort xform xconsent xdocument xstating xall xelements xof xICF xhave xbeen
xpresented xorally xto xpt/LAR
2) xOral xpresentation xof xrequired xelements
3) xIRB-approved xsummary xof xwhat xis xsaid
4) xWitness xpresent xduring xpresentation
How xdo xyou xdocument xshort xform xconsent? x- xcorrect xanswer. x x x x1) xSubject/LAR xsigns
xshort xform xconsent
2) xWitness xsigns xshort xform xconsent xand xsummary
3) xPerson xobtaining xconsent xsigns xsummary
x- xCopy xof xshort xform xconsent xand xsummary xare xgiven xto xsubject/LAR
How xdo xyou xdocument xlong xform xconsent? x- xcorrect xanswer. x x x xSubject/LAR xsigns xlong
xform xconsent
Do xyou xkeep xinformed xconsent xrecords xfor xpatients xwho xwithdraw xduring xstudy? x-
xcorrect xanswer. x x x xYes
CRA xshould xmonitor xwhat xelements xof xconsent xprocess? x(5) x- xcorrect xanswer. x x x x1)
xSubject xsigned xmost xrecent xversion xof xform
2) xSubject xsignature xand xname xare xboth xpresent
3) xSubject xdated xthemselves xand xdate xis xcorrect
4) xErrors xwere xcorrected xadequately
5) xAll xpages xof xICF xare xpresent
What xis xSource xData xVerification? x(SDV) x- xcorrect xanswer. x x x xCRF xor xother xdata
xcollection xinstruments xare xcompared xto xoriginal xsource xof xinformation xto xconfirm xdata
xaccuracy
What xis xSource xData xReview x(SDR) x- xcorrect xanswer. x x x xReview xof xsource
xdocumentation xto xcheck xquality, xand xreview xand xensure xprotocol xcompliance
What xis xthe xdefinition xof xan xadverse xevent x(AE)? x- xcorrect xanswer. x x x xSign, xsymptom,
xillness xor xuntoward xexperience xthat xdevelops xor xworsens xduring xa xstudy, xregardless xof
xrelation xto xstudy xtreatment
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