CCRP EXAM QUESTIONS AND CORRECT VERIFIED ANSWERS

CCRP EXAM QUESTIONS AND CORRECT
VERIFIED ANSWERS
HowA2manyA2daysA2doesA2aA2sponsorA2haveA2toA2reportA2anA2emergencyA2useA2ofA2anA2I
PA2toA2theA2FDA?A2-A2Ans--5A2workingA2days

HowA2manyA2membersA2mustA2sitA2onA2anA2IRB?A2-A2Ans--5

HowA2longA2mustA2anA2IRBA2retainA2recordsA2perA221A2CFRA256?A2-A2Ans--
3A2yearsA2afterA2completionA2ofA2research

WhatA2areA2theA2criteriaA2forA2IRBA2approvalA2ofA2research?A2(7)A2-A2Ans--
1.A2RisksA2toA2subjectsA2areA2minimized
2.A2RisksA2areA2reasonableA2inA2relationA2toA2anticipatedA2benefits
3.A2SelectionA2ofA2subjectsA2isA2equitable
4.A2InformedA2consentA2willA2beA2soughtA2fromA2subjectsA2orA2LARsA2
5.A2InformedA2consentA2willA2beA2documented
6.A2ThereA2isA2adequateA2provisionA2ofA2monitoring
7.A2ThereA2isA2adequateA2provisionA2toA2protectA2theA2privacyA2ofA2subjects

HowA2manyA2daysA2doesA2anA2IRBA2haveA2toA2reportA2aA2changeA2inA2registrationA2inform
ationA2dueA2toA2aA2changeA2inA2chairpersonA2orA2contact?A2-A2Ans--90A2days

HowA2manyA2daysA2doesA2anA2IRBA2haveA2toA2informA2theA2FDAA2thatA2itA2isA2reviewingA2
differentA2typesA2ofA2FDAA2products?A2-A2Ans--30A2days

HowA2oftenA2mustA2anA2IRBA2renewA2it'sA2registration?A2-A2Ans--3A2years

WhatA2areA2theA28A2basicA2elementsA2ofA2informedA2consentA2perA2FDAA2guidelines?A2-
A2Ans--
1.A2StatementA2thatA2theA2studyA2involvesA2research,A2purposeA2andA2expectedA2duration,
A2descriptionA2ofA2experimentalA2procedures
2.A2DescriptionA2ofA2reasonablyA2foreseeableA2risks
3.A2Benefits
4.A2DisclosureA2ofA2alternativeA2proceduresA2orA2coursesA2ofA2treatment
5.A2ConfidentialityA2measures
6.A2CompensationA2andA2treatmentsA2availableA2ifA2injuryA2occursA2
7.A2contactA2information
8.A2ParticipationA2isA2voluntaryA2andA2subjectA2mayA2discontinueA2atA2anyA2time

WhatA2areA2theA2criteriaA2forA2involvingA2childrenA2inA2minimalA2riskA2research?A2(2)A2-
A2Ans--1.A2NoA2greaterA2thanA2minimalA2risk
2.A2AssentA2fromA2kidA2+A2consentA2fromA2parentA2obtained

,WhatA2areA2theA2criteriaA2forA2involvingA2childrenA2inA2greaterA2thanA2minimalA2riskA2resea
rchA2withA2prospectA2ofA2benefit?A2(3)A2-A2Ans--1.A2RisksA2areA2justifiedA2byA2benefits
2.A2RelationA2ofA2anticipatedA2benefitA2isA2atA2leastA2asA2favorableA2asA2thatA2presentedA2
byA2alternativeA2approaches
3.A2AssentA2+A2consent

WhatA2areA2theA2criteriaA2forA2involvingA2childrenA2inA2greaterA2thanA2minimalA2riskA2resea
rchA2withA2noA2directA2benefit?A2(4)A2-A2Ans--
1.A2RisksA2areA2minorA2increaseA2overA2minimalA2risk
2.A2InterventionA2presentsA2experiencesA2thatA2areA2reasonableA2commensurateA2withA2n
ormalA2medicalA2andA2livingA2situations
3.A2InterventionA2isA2likelyA2toA2yieldA2generalizableA2knowledgeA2thatA2isA2vital
4.A2AssentA2+A2consent

SponsorsA2mustA2reportA2SAEsA2toA2theA2FDAA2withinA2howA2manyA2daysA2ofA2discoverin
gA2theA2event?A2-A2Ans--15A2calendarA2daysA2(21A2CFRA2312.32)

InvestigatorsA2mustA2reportA2SAEsA2toA2aA2sponsorA2withinA2howA2manyA2daysA2ofA2disco
veringA2theA2event?A2-A2Ans--ImmediatelyA2(21A2CFRA2312.64)

SponsorsA2mustA2reportA2whatA2kindA2ofA2seriousA2eventsA2toA2theA2FDAA2withinA215A2cale
ndarA2days?A2(4)A2-A2Ans--
1)A2SeriousA2andA2unexpectedA2suspectedA2adverseA2reactions
2)A2FindingsA2fromA2otherA2studiesA2thatA2suggestA2aA2significantA2riskA2inA2humans
3)A2FindingsA2fromA2animalA2orA2in-vitroA2testingA2thatA2suggestA2risksA2toA2humans
4)A2IncreasedA2rateA2ofA2occurrenceA2ofA2seriousA2suspectedA2adverseA2reactions

SponsorsA2mustA2submitA2UnanticipatedA2AdverseA2DeviceA2EffectsA2toA2theA2FDAA2withi
nA2howA2manyA2days?A2-A2Ans--10A2workingA2daysA2(21A2CFRA2812.15)

InvestigatorsA2mustA2submitA2UnanticipatedA2AdverseA2DeviceA2EffectsA2toA2theA2FDAA2wi
thinA2howA2manyA2days?A2-A2Ans--10A2workingA2daysA2(21A2CFRA2812.15)

WhenA2wasA2theA2NurembergA2CodeA2issued?A2-A2Ans--1947

WhatA2areA2theA210A2pointsA2madeA2inA2theA2NurembergA2Code?A2-A2Ans--
1)A2VoluntaryA2informedA2consentA2shouldA2beA2obtained
2)A2ResearchA2shouldA2yieldA2benefitA2toA2society
3)A2ResearchA2shouldA2beA2basedA2onA2animalA2work
4)A2AvoidA2unnecessaryA2suffering
5)A2Don'tA2doA2researchA2resultingA2inA2deathA2orA2disablingA2injury
6)A2RisksA2shouldA2beA2justifiedA2byA2benefits
7)A2ProperA2prepA2andA2adequateA2facilitiesA2shouldA2beA2used
8)A2ConductedA2byA2scientificallyA2qualifiedA2people
9)A2SubjectA2canA2withdrawA2whenever
10)A2ResearchersA2canA2endA2theA2studyA2ifA2risksA2areA2tooA2great

,WhenA2wasA2theA2DeclarationA2ofA2HelsinkiA2released?A2-A2Ans--1964

WhoA2developedA2theA2DeclarationA2ofA2Helsinki?A2-A2Ans--
WorldA2MedicalA2AssociationA2(WMA)

WhatA2isA2theA2DeclarationA2ofA2Helsinki?A2-A2Ans--
DocumentA2thatA2laidA2outA2generalA2principlesA2physiciansA2shouldA2followA2toA2conductA
2researchA2withA2humans,A2basedA2onA2NurembergA2Code.A2FirstA2effortA2ofA2medicalA2co
mmunityA2toA2regulateA2itself

WhenA2wasA2theA2BelmontA2ReportA2released?A2-A2Ans--1979

WhoA2createdA2theA2BelmontA2Report?A2-A2Ans--
NationalA2CommissionA2forA2theA2ProtectionA2ofA2HumanA2SubjectsA2ofA2BiomedicalA2and
A2BehavioralA2ResearchA2(atA2directionA2ofA2NationalA2ResearchA2ActA21974)


WhatA2areA2theA23A2principlesA2inA2theA2BelmontA2Report?A2-A2Ans--
1)A2RespectA2forA2Persons:A2informedA2consentA2requiredA2andA2individualsA2withA2dimini
shedA2autonomyA2getA2specialA2protections
2)A2Beneficence:A2maximizeA2benefitA2toA2researchA2whileA2minimizingA2riskA2toA2subjects
3)A2Justice:A2oneA2groupA2ofA2peopleA2shouldn'tA2assumeA2risksA2forA2theA2benefitA2ofA2an
otherA2(equalityA2andA2diversityA2ofA2participants)

InA2whatA2orderA2wereA2historicalA2declarationsA2forA2humanA2subjectsA2protectionA2releas
ed?A2-A2Ans--NurembergA2CodeA2>A2DeclarationA2ofA2HelsinkiA2>A2BelmontA2Report

AtA2whatA2readingA2levelA2shouldA2ICFsA2beA2written?A2-A2Ans--6th-8thA2grade

WhatA2FDAA2guidelineA2listsA2theA2basicA2elementsA2ofA2informedA2consent?A2-A2Ans--
21A2CFRA250A2(50.25)

WhatA2areA2theA2additionalA2elementsA2ofA2informedA2consentA2perA2FDAA2guidelines?
A2(7)A2-A2Ans--1)A2StatementA2thatA2treatmentA2mayA2involveA2unforseeableA2risks
2)A2CircumstancesA2inA2whichA2subjectA2participationA2mayA2beA2terminated
3)A2AdditionalA2costsA2toA2subject
4)A2ConsequencesA2ofA2subject'sA2decisionA2toA2withdraw
5)A2StatementA2thatA2newA2findingsA2willA2beA2providedA2toA2subject
6)A2#A2ofA2subjectsA2inA2study
7)A2clinicaltrials.govA2statementA2(asA2applicable)

WhoA2ultimatelyA2approvesA2anA2ICF?A2-A2Ans--IRBA2-
A2sponsorA2canA2provideA2sampleA2form

, DescribeA2theA22A2mostA2importantA2pointsA2toA2considerA2whenA2consentingA2patientsA2(p
erA221A2CFRA250)A2-A2Ans--
1)A2NoA2personA2canA2participateA2withoutA2theirA2orA2LARA2consentA2(50.20)
2)A2DocumentationA2ofA2informedA2consentA2isA2requiredA2(50.27)

WhatA2areA2theA24A2componentsA2ofA2theA2consentA2processA2usingA2aA2shortA2form?A2-
A2Ans--
1)A2ShortA2formA2consentA2documentA2statingA2allA2elementsA2ofA2ICFA2haveA2beenA2pres
entedA2orallyA2toA2pt/LAR
2)A2OralA2presentationA2ofA2requiredA2elements
3)A2IRB-approvedA2summaryA2ofA2whatA2isA2said
4)A2WitnessA2presentA2duringA2presentation

HowA2doA2youA2documentA2shortA2formA2consent?A2-A2Ans--1)A2Subject/
LARA2signsA2shortA2formA2consent
2)A2WitnessA2signsA2shortA2formA2consentA2andA2summary
3)A2PersonA2obtainingA2consentA2signsA2summary
A2-A2CopyA2ofA2shortA2formA2consentA2andA2summaryA2areA2givenA2toA2subject/LAR


HowA2doA2youA2documentA2longA2formA2consent?A2-A2Ans--Subject/
LARA2signsA2longA2formA2consent

DoA2youA2keepA2informedA2consentA2recordsA2forA2patientsA2whoA2withdrawA2duringA2stud
y?A2-A2Ans--Yes

CRAA2shouldA2monitorA2whatA2elementsA2ofA2consentA2process?A2(5)A2-A2Ans--
1)A2SubjectA2signedA2mostA2recentA2versionA2ofA2form
2)A2SubjectA2signatureA2andA2nameA2areA2bothA2present
3)A2SubjectA2datedA2themselvesA2andA2dateA2isA2correct
4)A2ErrorsA2wereA2correctedA2adequately
5)A2AllA2pagesA2ofA2ICFA2areA2present

WhatA2isA2SourceA2DataA2Verification?A2(SDV)A2-A2Ans--
CRFA2orA2otherA2dataA2collectionA2instrumentsA2areA2comparedA2toA2originalA2sourceA2ofA2
informationA2toA2confirmA2dataA2accuracy

WhatA2isA2SourceA2DataA2ReviewA2(SDR)A2-A2Ans--
ReviewA2ofA2sourceA2documentationA2toA2checkA2quality,A2andA2reviewA2andA2ensureA2pro
tocolA2compliance

WhatA2isA2theA2definitionA2ofA2anA2adverseA2eventA2(AE)?A2-A2Ans--
Sign,A2symptom,A2illnessA2orA2untowardA2experienceA2thatA2developsA2orA2worsensA2durin
gA2aA2study,A2regardlessA2ofA2relationA2toA2studyA2treatment

HowA2areA2AEsA2documented?A2-A2Ans---
A2InA2AEA2CRFA2forA2sponsorA2(orA2otherA2studyA2collectionA2mechanism)