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SOCRA Practice Test With Complete Solutions
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SOCRA Practice Test With CompleteSolutions
Which nnof nnthe nnfollowing nnis nna nndisclosure nnof nnfinancial nninterests nnform? nn- nnANSWER: nn✔ nnFDA nnForm
nn3455
Which nnof nnthe nnfollowing nnis nna nncertification nnof nnfinancial nninterest nnform? nn- nnANSWER: nn✔ nnFDA nnForm
nn3454
If nnthe nninvestigator nndid nnhave nnfinancial nnarrangement nnwith nnthe nnsponsor, nnhe/she nnwould nnsubmit nnthe
nnfollowing nnform: nn- nnANSWER: nn✔ nnFDA nnForm nn3455
This nnform nnis nnsubmitted nnby nnsponsor nnto nnthe nnFDA nnprior nnto nnthe nnbeginning nnof nnthe nndrug nntrial nn-
nnANSWER: nn✔ nnInvestigational nnNew nnDrug nnApplication nn(1571)
In nnthe nntop nnright nncorner, nnform nnhave nnOMB nnnumber. nnWhat nndoes nnit nnstand nnfor? nn- nnANSWER: nn✔
nnOffice nnof nnManagement nnand nnBudget
The nnform, nnwhich nnis nnsubmitted nnto nnthe nnFDA nnto nnreport nnan nnAdverse nnEvent nnis nn- nnANSWER: nn✔ nn3500
Medical nndevice nnadverse nnevents/problems nnare nnreported nnvia nna nnform: nn- nnANSWER: nn✔ nn3500A
What nnis nnFDA nnform nn1571? nn- nnANSWER: nn✔ nnCover-sheet nnfor nnInvestigational nnNew nnDrug nnApplications
21 nnCFR nn312 nndeals nnwith nn- nnANSWER: nn✔ nnInvestigational nnNew nnDrug nnApplication
Investigational nnnew nndrug nnmeans nn- nnANSWER: nn✔ nnA nnnew nndrug nnor nnbiological nndrug nnthat nnis nnused nnin
nna nnclinical nninvestigation
, The nnimmediate nnpackage nnof nnan nninvestigational nnnew nndrug nnintended nnfor nnhuman nnuse nnshall nnbear nna
nnlabel nnwith nnthe nnstatement nn- nnANSWER: nn✔ nn"Caution: nnNew nnDrug—Limited nnby nnFederal nn(or nnUnited
nnStates) nnlaw nnto nninvestigational nnuse."
Which nnof nnthe nnfollowing nnis nnnot nnlisted nnon nnFDA nnform nn1571: nn- nnANSWER: nn✔ nnApproved nninformed
nnconsent nndocument
"Any nnadverse nndrug nnexperience nnthat nnplaces nnthe nnpatient nnor nnsubject, nnin nnthe nnview nnof nnthe
nninvestigator, nnat nnimmediate nnrisk nnof nndeath nnfrom nnthe nnreaction nnas nnit nnoccurred" nnIs... nn- nnANSWER: nn✔
nnLife nnthreatening nnadverse nndrug nnexperience
What nnare nnthe nnthree nnmain nnbasic nnethical nnprinciples nnof nnthe nnBelmont nnReport? nn- nnANSWER: nn✔ nn1.
nnRespect nnfor nnPersons
2. nnBeneficence
3. nnJustice
What nnare nnthe nnapplications nnfor nnthe nnBelmont nnReport? nn- nnANSWER: nn✔ nn1. nnInformed nnConsent
2. nnAssessment nnof nnRisk nnand nnBenefits
3. nnSelection nnof nnSubjects
What nnphrase nnof nna nndrug nntrial nnusually nnincludes nnhundreds nnto nnthousands nnof nnvolunteers? nn-
nnANSWER: nn✔ nnPhase nn3: nnThese nnstudies nngather nnmore nninformation nnabout nnsafety nnand nneffectiveness,
nnstudy nndifferent nnpopulations nnand nndifferent nndosages, nnand nnuses nnthe nndrug nnin nncombination nnwith
nnother nndrugs.
What nnis nna nndrug nnas nndefined nnby nnthe nnFDA? nn- nnANSWER: nn✔ nnA nndrug nnis nnan nnproduct nnthat nnis
nnintended nnfor nnuse nnin nnthe nndiagnosis, nncure nnmitigation, nntreatment, nnor nnprevention nnof nndisease; nnand
nnthat nnis nnintended nnto nnaffect nnthe nnstructure nnor nnany nnfunction nnof nnthe nnbody.
What nnis nnPhase nn1 nnof nna nnclinical nntrial? nn- nnANSWER: nn✔ nn20-80: nnTypical nnnumber nnof nnhealthy
nnvolunteers nnused nnin nnPhase nn1: nnthis nnphase nnemphasizes nnSAFETY.
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