ACRP ICH Exam Challenge (100% Solved)
Whosissresponsiblesforsprovidingsthestrialsprotocols-sThesSponsor
Documentsswhichsindividuallysandscollectivelyspermitsevaluationsofsthesconductsofsasstudysa
ndsthesqualitysofsthesdatasproducedsarescalled..?s-sEssentialsdocuments
Allsinformationsinsoriginalsrecordssandscertifiedscopiessofsoriginalsrecordssofscriticalsfinding
s,sobservations,sorsothersactivitiessinsasclinicalstrialsnecessarysforsthesreconstructionsandseva
luationsofsthestrialsarescalled..?s-sSourcesData
OnesofsthesprimaryspurposessofsasPhasesIsstudysisstosdeterminesthesmetabolicsandspharmaco
logicsactionsofsthesdrugsinshumans.s-sTrue
ThespurposesofsthesIRB/IECsisstosprojectssubjectssafety.s-sTrue
WhosissultimatelysresponsiblesforsSDV?s-sThesMonitor
Moststypicalsstudy,sinvestigatesshumanspharmacology.sItsissthesinitialsadministrationsofsansi
nvestigationalsnewsdrugsintoshumans.sItsissmostscommonlysdonesinshealthyssubjects.sWhichs
phasesifsthis?s-sPhasesI
WhatsissthesminimumsnumbersofsmemberssonsansIRB/IEC?s-s5
ThespurposesofsICH-
GCPsisstosstandardizesthesdesign,sconduct,srecordingsandsreportingsofsclinicalstrials.s-sTrue
ThespurposesofsthesDSMBsisstosassesssthesprogresssofsasclinicalstrial,sthessafetysdata,sandsthes
criticalsefficacysendpoints.s-sTrue
Thesprocesssbyswhichsassubjectsvoluntarilysconfirmsshissorsherswillingnessstosparticipatesins
asclinicalstrialsissknownsas..s-sInformedsConsent
ThesDeclarationsofsHelsinkiswassdevelopedsby...s-sThesWorldsMedicalsAssociation
Whichsphasesdeterminesstherapeuticsbenefitsandsissusuallysdonesinsaslarger,sspecificspopulat
ion?s-sPhasesIII
Ansindividual,scompany,sinstitutionsorsorganizationswhichstakessresponsibilitysforsthesinitiat
ion,smanagement,sand/orsfinancingsofsasclinicalstrialsisscalledsthe....s-sSponsor
Thesmainsgoalsofsthissphasesofsdrugsdevelopmentsisstosexplorestherapeuticsefficacysinspatien
ts.sItsissimportantsduringsthissphasestosdeterminesthesdose(s)sandsregimenssthatswillsbesused
sforslaterstrials.s-sPhasesII
Whosissresponsiblesforsprovidingsthestrialsprotocols-sThesSponsor
Documentsswhichsindividuallysandscollectivelyspermitsevaluationsofsthesconductsofsasstudysa
ndsthesqualitysofsthesdatasproducedsarescalled..?s-sEssentialsdocuments
Allsinformationsinsoriginalsrecordssandscertifiedscopiessofsoriginalsrecordssofscriticalsfinding
s,sobservations,sorsothersactivitiessinsasclinicalstrialsnecessarysforsthesreconstructionsandseva
luationsofsthestrialsarescalled..?s-sSourcesData
OnesofsthesprimaryspurposessofsasPhasesIsstudysisstosdeterminesthesmetabolicsandspharmaco
logicsactionsofsthesdrugsinshumans.s-sTrue
ThespurposesofsthesIRB/IECsisstosprojectssubjectssafety.s-sTrue
WhosissultimatelysresponsiblesforsSDV?s-sThesMonitor
Moststypicalsstudy,sinvestigatesshumanspharmacology.sItsissthesinitialsadministrationsofsansi
nvestigationalsnewsdrugsintoshumans.sItsissmostscommonlysdonesinshealthyssubjects.sWhichs
phasesifsthis?s-sPhasesI
WhatsissthesminimumsnumbersofsmemberssonsansIRB/IEC?s-s5
ThespurposesofsICH-
GCPsisstosstandardizesthesdesign,sconduct,srecordingsandsreportingsofsclinicalstrials.s-sTrue
ThespurposesofsthesDSMBsisstosassesssthesprogresssofsasclinicalstrial,sthessafetysdata,sandsthes
criticalsefficacysendpoints.s-sTrue
Thesprocesssbyswhichsassubjectsvoluntarilysconfirmsshissorsherswillingnessstosparticipatesins
asclinicalstrialsissknownsas..s-sInformedsConsent
ThesDeclarationsofsHelsinkiswassdevelopedsby...s-sThesWorldsMedicalsAssociation
Whichsphasesdeterminesstherapeuticsbenefitsandsissusuallysdonesinsaslarger,sspecificspopulat
ion?s-sPhasesIII
Ansindividual,scompany,sinstitutionsorsorganizationswhichstakessresponsibilitysforsthesinitiat
ion,smanagement,sand/orsfinancingsofsasclinicalstrialsisscalledsthe....s-sSponsor
Thesmainsgoalsofsthissphasesofsdrugsdevelopmentsisstosexplorestherapeuticsefficacysinspatien
ts.sItsissimportantsduringsthissphasestosdeterminesthesdose(s)sandsregimenssthatswillsbesused
sforslaterstrials.s-sPhasesII
