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ClinicalResearchProfessional
Certification&Preparingforthe
CCRPExam
SigneDenmark,MS,CCRP
ToniMauney,CCRP

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SoCRA:SocietyofClinicalResearchAssociates

SoCRAestablishedthe
CertificationProgramforClinical
ResearchProfessionalsinorderto
createaninternationally
acceptedstandardofknowledge,
education,andexperienceby
whichclinicalresearch
professionalswillberecognized
bythehealthcareresearch
community.
Individualsapprovedmayusethe
titleofCertifiedClinicalResearch
ProfessionalorC.C.R.P
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UpcomingSoCRA
CertificationExam

Date:Saturday,September20,2014
Place:MUSC,ARTAuditorium
Time:9AM1PM
Cost:$195
www.socra.org

RegistrationdeadlinefortheMUSCexamis:
August8,2014

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WhoiseligibleforSoCRA
Certification?

Theapplicantmustmeetoneofthefollowingcriteria:
2yearsofexperienceasafulltimeClinicalResearchProfessional
(orhave3,500hoursparttime)duringthelastfiveyearsOR
AssociatesorBachelorsDegreeinClinicalResearchAND have1
yearoffulltimeexperience(or1750parttimehours)duringthe
lasttwoyearsinanareaofclinicalresearchOR
CertificateofCompletionfromanUndergraduateorGraduate
ClinicalResearchcurriculumofnolessthan12semester(credit)
hoursatanacademicallyaccreditedinstitutionofhigherlearning
(communitycollege,collegeoruniversity)AND holdan
AssociatesorBachelorsDegreeinscience,healthscience,
pharmacyorrelatedfieldPLUS have1yearoffulltime
experience(or1750hoursparttime)duringthepast2yearsin
anareaofclinicalresearch.

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WhyShouldIObtainCertification?

Acknowledgementofyour
expertise
Competitiveedgeinvying
forinnovativeclinicaltrials
Professionalnetworkingand
development

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AbouttheCertificationExam

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Thecertificationexaminationis
madeupoffivemajorsubject
areas
Thereare135questions
Eachmajorareawillbeincludedin
eachexamination,butspecific
questionswillvaryfromone
examinationdatetoanother
Thepercentageofquestionsfrom
eachareawillchangeslightlyfrom
oneexaminationtoanother,with
eachquestionequivalentinweight

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FiveSubjectAreasoftheExam

PercentofScoredTestItemsinEachArea
EthicalPrinciples/InformedConsent/Safety=20%
25%
InstitutionalReviewBoard/InstitutionalEthics
Committee(IRB/IEC)RolesandResponsibilities=7%
11%
ClinicalTrialProtocolandProtocolAmendments=4%
8%
InvestigatorRolesandResponsibilities=28% 32%
SponsorRolesandResponsibilities=31% 35%
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FiveSubjectAreasoftheExam

EthicalPrinciples/InformedConsent/Safety
(20% 25%)
NurembergCode
BelmontReport
DeclarationofHelsinki
Informedconsentincludingdevelopment,content,review,approval,
discussion,documentationandongoingupdates
Maintenanceofinformedconsentdocuments(paper/electronic)
Abstracting/verificationofinformationfrommedicalrecordsrelatedto
informedconsentandsafetyreporting
Vulnerablesubjects
SafetyReporting(adverseevents,seriousadversedrugexperiences,
unanticipatedadversedeviceeffects)
Financialdisclosure

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FiveSubjectAreasoftheExam

InstitutionalReviewBoard/InstitutionalEthics
Committee(IRB/IEC)RolesandResponsibilities
(7% 11%)

RolesandResponsibilitiesroles,etc.ofIRB/IEC
Determinationthattherights,welfareandsafetyofstudysubjects
includingvulnerablepopulationsareprotected
DevelopmentandimplementationofStandardOperatingProcedures
(SOPs)
Membership
SignificantRisk/NonSignificantMedicalDevicestudydetermination
Documentation
RecordretentionIRB/IEC

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FiveSubjectAreasoftheExam

ClinicalTrialProtocolandProtocol
Amendments (4% 8%)
Protocoldevelopment(includingstudydesignwith
considerationsmethodstoreducebias,objectives,
endpoints,datasafetymonitoring)
ProtocolAmendments

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FiveSubjectAreasoftheExam

InvestigatorsRolesandResponsibilities
(28% 32%)

Roles,responsibilitiesandobligationsoftheinvestigator
Studyconductinaccordancewithinvestigationalplan,investigatoragreement
andapplicableregulations
Protocol(s)andprotocolrelateddocument(s)(i.e.,informedconsentdocuments,
recruitmentmaterials,safetyreports,continuingreviews)development,review,
andsubmissionforreviewingauthorities
Recruitment,screening,enrollment,andretentionofsubjects
Investigationalsitesourcedocumentation
Documentation/Reportingdiscontinuationstudysubjects
Investigationalsitestudyrelatedreports(i.e.progressreports,protocolchanges,
protocoldeviations,finalreports)
SourceDocumentation/CaseReportForms
Maintenanceofessentialstudyrelateddocuments(paper/electronic)
Abstracting/verificationofInformationfromMedicalRecords
Recordretentionrequirementsforclinicalsites

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FiveSubjectAreasoftheExam

SponsorsRolesandResponsibilities
(31% 35%)

Investigator/sitequalification
Investigationalsitetraining,management,oversightandinvestigator
compliance(includingGCP,investigationalproduct,studyandreporting
requirements)
Protocolandprotocolrelateddocuments
Sponsorinvestigationalproductaccountability
Standardoperatingprocedures
Regulatorydocuments(FDAForms1571,1572,3454,3455,IND,IDE,
Medwatch(3500and3500A))
Studyplan
Development,verification,maintenanceofelectronicrecordsandelectronic
recordsystems
Maintenanceofessentialstudyrelateddocuments(paper/electronic)

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ExamStructure

135multiplechoiceandtrue/falsequestions
CaseStudies:Theexaminationwillcontaincase
studiesthatrelatetoclinicalresearchpractice.
Thecasestudiesareintendedtoevaluatea
candidatesabilitytoabstractdataanddonot
requireclinicalexperience.Casestudiesmay
involvequestionsregardingscheduling,dose
modificationsandreadingmedicalandclinical
reports.

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SoCRA
ExamPreparation

Utilizethematerialsprovidedandreviewyourstudyguide.The
CertificationProgramReferenceManualincludes:
TheNurembergCode
TheBelmontReport
TheDeclarationofHelsinki
21U.S.CodeofFederalRegulations Parts11,50,56,312,812
45U.S.CodeofFederalRegulations Part46
ICHGCPGuidelineforGoodClinicalPractice(E6),and
ICHClinicalSafetyDataManagement:DefinitionsandStandardsfor
ExpeditedReporting(E2A)
Pleasenote: TheHealthCanadaSectionsareprintedasreferencematerial.
YouwillNOTbetestedoncontentrelatedtothissectiononthecertification
examination.

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SoCRA
ExamPreparationTips

Dontgetoverwhelmedbytheamountoftextinthe
regulations.Pulloutthekeypointsandorganizeyour
thoughts.
Beconfident.Overyourtimeinresearch,youknowalot
morethanyouthink.
Testsmart.Dontgetstuckonquestions.Dont
overanalyze.Putaplaceholderonyouranswersheet,
moveonandcomebacktoadifficultquestionlater.
Patientsafetyfirst.Whenindoubt,gofortheanswer
thatoffersthebestprotectiontothesubjectsrightsand
welfare.

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SoCRA
StudySessions

Thursday,8/14,11:30AM12:30PM EthicalPrinciples,InformedConsent,
ResearchNexusConferenceRoomCSB214A
Safety
Wednesday,8/20,12:00PM1:00PM IRB/IECRolesandResponsibilities
ResearchNexusConferenceRoomCSB214A

Thursday,8/28,11:30AM12:30PM ClinicalTrialProtocolandProtocol
ResearchNexusConferenceRoomCSB214A
Amendments
Wednesday,9/3,12:00PM1:00PM InvestigatorsRolesand
ResearchNexusConferenceRoomCSB214AResponsibilities
Thursday,9/11,11:30PM12:30PM SponsorsRolesand
ResearchNexusConferenceRoomCSB214AResponsibilities
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