SOCRA Practice Test Questions And
Answers
Which bof bthe bfollowing bis ba bdisclosure bof bfinancial binterests bform? b- bcorrect
banswers✔✔FDA bForm b3455
Which bof bthe bfollowing bis ba bcertification bof bfinancial binterest bform? b- bcorrect
banswers✔✔FDA bForm b3454
If bthe binvestigator bdid bhave bfinancial barrangement bwith bthe bsponsor, bhe/she bwould
bsubmit bthe bfollowing bform: b- bcorrect banswers✔✔FDA bForm b3455
This bform bis bsubmitted bby bsponsor bto bthe bFDA bprior bto bthe bbeginning bof bthe bdrug
btrial b- bcorrect banswers✔✔Investigational bNew bDrug bApplication b(1571)
In bthe btop bright bcorner, bform bhave bOMB bnumber. bWhat bdoes bit bstand bfor? b-
bcorrect banswers✔✔Office bof bManagement band bBudget
The bform, bwhich bis bsubmitted bto bthe bFDA bto breport ban bAdverse bEvent bis b-
bcorrect banswers✔✔3500
Medical bdevice badverse bevents/problems bare breported bvia ba bform: b- bcorrect
banswers✔✔3500A
What bis bFDA bform b1571? b- bcorrect banswers✔✔Cover-sheet bfor bInvestigational
bNew bDrug bApplications
21 bCFR b312 bdeals bwith b- bcorrect banswers✔✔Investigational bNew bDrug bApplication
Investigational bnew bdrug bmeans b- bcorrect banswers✔✔A bnew bdrug bor bbiological
bdrug bthat bis bused bin ba bclinical binvestigation
The bimmediate bpackage bof ban binvestigational bnew bdrug bintended bfor bhuman buse
bshall bbear ba blabel bwith bthe bstatement b- bcorrect banswers✔✔"Caution: bNew bDrug—
Limited bby bFederal b(or bUnited bStates) blaw bto binvestigational buse."
, Which bof bthe bfollowing bis bnot blisted bon bFDA bform b1571: b- bcorrect
banswers✔✔Approved binformed bconsent bdocument
"Any badverse bdrug bexperience bthat bplaces bthe bpatient bor bsubject, bin bthe bview bof
bthe binvestigator, bat bimmediate brisk bof bdeath bfrom bthe breaction bas bit boccurred"
bIs... b- bcorrect banswers✔✔Life bthreatening badverse bdrug bexperience
What bare bthe bthree bmain bbasic bethical bprinciples bof bthe bBelmont bReport? b-
bcorrect banswers✔✔1. bRespect bfor bPersons
2. bBeneficence
3. bJustice
What bare bthe bapplications bfor bthe bBelmont bReport? b- bcorrect banswers✔✔1.
bInformed bConsent
2. bAssessment bof bRisk band bBenefits
3. bSelection bof bSubjects
What bphrase bof ba bdrug btrial busually bincludes bhundreds bto bthousands bof
bvolunteers? b- bcorrect banswers✔✔Phase b3: bThese bstudies bgather bmore
binformation babout bsafety band beffectiveness, bstudy bdifferent bpopulations band
bdifferent bdosages, band buses bthe bdrug bin bcombination bwith bother bdrugs.
What bis ba bdrug bas bdefined bby bthe bFDA? b- bcorrect banswers✔✔A bdrug bis ban
bproduct bthat bis bintended bfor buse bin bthe bdiagnosis, bcure bmitigation, btreatment, bor
bprevention bof bdisease; band bthat bis bintended bto baffect bthe bstructure bor bany
bfunction bof bthe bbody.
What bis bPhase b1 bof ba bclinical btrial? b- bcorrect banswers✔✔20-80: bTypical bnumber
bof bhealthy bvolunteers bused bin bPhase b1: bthis bphase bemphasizes bSAFETY.
What bis bPhase b2 bof ba bclinical btrial? b- bcorrect banswers✔✔100s: bTypical bnumber bof
bpatients bused bin bPhase b2; bthis bphase bemphasizes bEFFECTIVENESS
What bis bPhase b3 bof ba bclinical btrial? b- bcorrect banswers✔✔1000's b:Typical bnumber
bof bpatients bused bin bPhase. b3. bThese bstudies bgather bmore binformation babout
bsafety band beffectiveness, bstudy bdifferent bpopulations band bdifferent bdosages, band
buses bthe bdrug bin bcombination bwith bother bdrugs.
What bis bPhase b4 bof ba bclinical btrial? b- bcorrect banswers✔✔Post bMarketing:
bBecause bit's bnot bpossible bto bpredict ball bof ba bdrug's beffects bduring bclinical btrials,
bmonitoring bsafety bissues bafter bdrugs bget bon bthe bmarket bis bcritical. bThe brole bof
bFDA's bpost-marketing bsafety bsystem bis bto bdetect bserious bunexpected badverse
bevents band btake bdefinitive baction bwhen bneeded.
The bmain bconcept bof b21 bCFR b50 bis b- bcorrect banswers✔✔Protection bof bHuman
bSubjects
Answers
Which bof bthe bfollowing bis ba bdisclosure bof bfinancial binterests bform? b- bcorrect
banswers✔✔FDA bForm b3455
Which bof bthe bfollowing bis ba bcertification bof bfinancial binterest bform? b- bcorrect
banswers✔✔FDA bForm b3454
If bthe binvestigator bdid bhave bfinancial barrangement bwith bthe bsponsor, bhe/she bwould
bsubmit bthe bfollowing bform: b- bcorrect banswers✔✔FDA bForm b3455
This bform bis bsubmitted bby bsponsor bto bthe bFDA bprior bto bthe bbeginning bof bthe bdrug
btrial b- bcorrect banswers✔✔Investigational bNew bDrug bApplication b(1571)
In bthe btop bright bcorner, bform bhave bOMB bnumber. bWhat bdoes bit bstand bfor? b-
bcorrect banswers✔✔Office bof bManagement band bBudget
The bform, bwhich bis bsubmitted bto bthe bFDA bto breport ban bAdverse bEvent bis b-
bcorrect banswers✔✔3500
Medical bdevice badverse bevents/problems bare breported bvia ba bform: b- bcorrect
banswers✔✔3500A
What bis bFDA bform b1571? b- bcorrect banswers✔✔Cover-sheet bfor bInvestigational
bNew bDrug bApplications
21 bCFR b312 bdeals bwith b- bcorrect banswers✔✔Investigational bNew bDrug bApplication
Investigational bnew bdrug bmeans b- bcorrect banswers✔✔A bnew bdrug bor bbiological
bdrug bthat bis bused bin ba bclinical binvestigation
The bimmediate bpackage bof ban binvestigational bnew bdrug bintended bfor bhuman buse
bshall bbear ba blabel bwith bthe bstatement b- bcorrect banswers✔✔"Caution: bNew bDrug—
Limited bby bFederal b(or bUnited bStates) blaw bto binvestigational buse."
, Which bof bthe bfollowing bis bnot blisted bon bFDA bform b1571: b- bcorrect
banswers✔✔Approved binformed bconsent bdocument
"Any badverse bdrug bexperience bthat bplaces bthe bpatient bor bsubject, bin bthe bview bof
bthe binvestigator, bat bimmediate brisk bof bdeath bfrom bthe breaction bas bit boccurred"
bIs... b- bcorrect banswers✔✔Life bthreatening badverse bdrug bexperience
What bare bthe bthree bmain bbasic bethical bprinciples bof bthe bBelmont bReport? b-
bcorrect banswers✔✔1. bRespect bfor bPersons
2. bBeneficence
3. bJustice
What bare bthe bapplications bfor bthe bBelmont bReport? b- bcorrect banswers✔✔1.
bInformed bConsent
2. bAssessment bof bRisk band bBenefits
3. bSelection bof bSubjects
What bphrase bof ba bdrug btrial busually bincludes bhundreds bto bthousands bof
bvolunteers? b- bcorrect banswers✔✔Phase b3: bThese bstudies bgather bmore
binformation babout bsafety band beffectiveness, bstudy bdifferent bpopulations band
bdifferent bdosages, band buses bthe bdrug bin bcombination bwith bother bdrugs.
What bis ba bdrug bas bdefined bby bthe bFDA? b- bcorrect banswers✔✔A bdrug bis ban
bproduct bthat bis bintended bfor buse bin bthe bdiagnosis, bcure bmitigation, btreatment, bor
bprevention bof bdisease; band bthat bis bintended bto baffect bthe bstructure bor bany
bfunction bof bthe bbody.
What bis bPhase b1 bof ba bclinical btrial? b- bcorrect banswers✔✔20-80: bTypical bnumber
bof bhealthy bvolunteers bused bin bPhase b1: bthis bphase bemphasizes bSAFETY.
What bis bPhase b2 bof ba bclinical btrial? b- bcorrect banswers✔✔100s: bTypical bnumber bof
bpatients bused bin bPhase b2; bthis bphase bemphasizes bEFFECTIVENESS
What bis bPhase b3 bof ba bclinical btrial? b- bcorrect banswers✔✔1000's b:Typical bnumber
bof bpatients bused bin bPhase. b3. bThese bstudies bgather bmore binformation babout
bsafety band beffectiveness, bstudy bdifferent bpopulations band bdifferent bdosages, band
buses bthe bdrug bin bcombination bwith bother bdrugs.
What bis bPhase b4 bof ba bclinical btrial? b- bcorrect banswers✔✔Post bMarketing:
bBecause bit's bnot bpossible bto bpredict ball bof ba bdrug's beffects bduring bclinical btrials,
bmonitoring bsafety bissues bafter bdrugs bget bon bthe bmarket bis bcritical. bThe brole bof
bFDA's bpost-marketing bsafety bsystem bis bto bdetect bserious bunexpected badverse
bevents band btake bdefinitive baction bwhen bneeded.
The bmain bconcept bof b21 bCFR b50 bis b- bcorrect banswers✔✔Protection bof bHuman
bSubjects
