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ACRP Bootcamp Exam (61 Questions) With 100% Correct Verified Answers
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ACRP Bootcamp Exam (61 Questions) With100% Correct Verified Answers
Thesclinicalstrialsphasesthatsfocusessonssafetysandshumanspharmacologysinshealthysvoluntee
rssis:
a.sphases1
b.sphases2
c.sphases3
d.sphases4s
Whichsofsthesfollowingsissnotsastypesofspatient-orientedsresearch?
a.sIND/IDEsclinicalstrials
b.sinvestigatorsinitiatedstrials(IIT)
c.sPostsmarketsdevicesregistries
d.soutcomesandshealthsservicessresearchs
Whosissultimatelysresponsiblesforsallsaspectssofsthesresearchsconductedsatsassite?
a.sIRB
b.ssponsor
c.sprincipalsinvestigator
d.sclinicalsresearchscoordinators
Whatsissthesdefinitionsofsgoodsclinicalspractices(GCP)?
a.strainingsprovidedsbyssponsorsstossitesstaff
b.sregulationssprovidedsbysthesFDA
c.sstandardssdevelopedsbyseuropeansunion
d.sansinternationalsqualitysstandardsthatsissprovidedsbysICHs
WhatseventsresultedsinsthesNuremburgsCodesins1949?
a.sthalidomidestragedy
b.stuskegeessyphilissstudy
c.ssulfanilamidesElixirstragedy
d.snazismedicalsexperimentss
WhatsissthesICHsguidelinesthatsissknownsassthesGCPsguideline?
a.sE2A
b.sE6(R2)
, c.sE11
d.sE9s
WhichsosthesfollowingsissnotsasbasicsethicalsprinciplesaccordingstosthesBelmontsReport?
a.svulnerability
b.sbeneficence
c.srespectsforspersons
d.sjustices
ThissFDAscentersthatsregulatessblood,svaccines,sgenestherapy,sandstissuessis
a.sBIMO
b.sCBER
c.sCDER
d.sCDRHs
Whatsissthesinternationalsconferencesonsharmonizations(ICH)sguidelines?
a.swrittenspoliciessforsresearcherssonshowstosmaintainsdatasonsunmarketedsinvestigationalsp
roducts
b.sasguidelinesprovidedsbysthesofficesforshumansresearchsprotectionsforssubjectssenrollingsins
phases1sstudies
c.sasunifiedsstandardstosfacilitatesthesmutualsacceptancesofsclinicalsdatasbysthesregulatorysaut
horitiessinstheseuropeansunion,sjapansandsthesunitedsstates
d.sansinternationalsstandardsforsmanufacturing,stransporting,sandsstoringsmedicinalsproduct
ss
Tosbesasqualifyingsclinicalstrial,swhichsthreesrequirementssmustsbesmet?
a.sthestrialshasstherapeuticsintent,shassansinvestigationalsnewsdrugsnumber,sandsenrollsspati
entsswithsdiagnosedsdisease
b.sthestrialshasstherapeuticsintent,senrollsspatientsswithsdiagnosedsdiseasesandsevaluatessansi
tem/servicesthatsfallsswithinsasmedicaresbenefitscategory
c.sthestrialshasstherapeuticsintent,shassansinvestigationalsnewsdrugsnumber,sandsdoessnotseva
luatesansitem/servicesthatsfallsswithinsasmedicaresbenefitscategory
d.sthestrialshassansinvestigationalsnewsdrugsnumber,sdoessnotsenrollspatientsswithsdiagnosed
sdiseasesandsevlauatessansitem/servicesthatsfallsswithinsasmedicaresbenefitscategorys
Asprocesssbyswhichsassubjectsvoluntarilysconfirmsshissorsherswillingnessstosparticipatesinsasp
articularstrial,saftershavingsbeensinformedsofsallsaspectssofsthestrialsthatsaresrelevantstosthess
ubject'ssdecisionstosparticipatesissknownsassan:
a.sassent
b.sinformedsconsent
c.ssubjectsagreement
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