JHUSOM制定的访问学者培训要求及计划.docx

JHUSOM制定的访问学者培训要求及计划.docx

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JHUSOM制定的访问学者培训要求及计划

附件2.JHUSOM制定的访问学者培训要求及计划

1.ClinicalResearchFellowforVisiting

ThepurposeofthisFellowshipwillbetodevelopknowledgeandskillsintheconductofclinicalresearch.Theareaofexpertisewillbepredeterminedbasedontheinterestsandskillsofthefellow,aswellastheassignedmentor.

Activities:

∙Workwithaninterdisciplinaryresearchteamonastudyfocusedonthediseaseareapredetermined

∙Thismayincludeparticipatinginanon-goingresearchprojectaspartoftheworkofthisteam,aswellasdevelopanindependentproject.

∙DevelopaproposalforaresearchprojecttobeconductedafterreturningtoSunYat-senandprepareagrantapplicationforfundingforthisproject.

∙Participateinthedevelopmentofmanuscriptsforpublicationaddressingtheprojectsabove.

∙AssistinthedevelopmentofanIRBsubmissionforaclinicalresearchprojecttolearnmoreabouthumansubjectsprotectionandethicalissuesinclinicalresearch.

∙Participateinseriesofonlineorclassroomlecturestolearnmoreabouttheethicandintegrityinclinicalresearch.

∙Participateindepartmentgrandround,journalclubandotherrelevantseminars

FellowshipDevelopmentalObjectives:

Bytheendofthefellowship,thefellowwillbeableto:

∙Serveasaleaderormentoredleaderofaninterdisciplinaryresearchteam

∙Describeanethicalframeworkandpracticestoguideresearchwithhumansubjects.

∙Preparedata-basedmanuscriptsforpublicationalongwithotherresearchteammembers.

∙Prepareagrantapplicationforaresearchstudyaddressingchronicdiseasemanagement.

Mentors:

WillbeidentifiedbyJHUbasedonhis/herinterest,availabilityandexpertise.Fellowsshouldmeetregularlyandfrequently（weeklyorbi-weekly）withthementor.Amentorshipcommitteewillbecreatedandwillmeetwiththeapplicantquarterlytoreviewthefellow’sprogress.

Coursework:

TherearenumerouscoursesinJHUthatmaybeofinteresttothefellow,includingepidemiology,biostatistics,grantwriting,andwritingforpublication.Therearealsoclinicalcoursesthatfocusontheadvancedclinicalpractices.

ContinuingEducation:

Thereisalsoanopportunityforcontinuingeducationontheroleofaninvestigator.Theseopportunitiesincludeshadowingresearcherstolearnabouttheirroleandtoobserveinstitutionalreviewboard（IRB）meetingswithfacultymemberswhoserveontheJohnsHopkinsMedicineIRBs.

Requirements/Qualifications:

ThefacultyfellowshouldhaveaMDDegreeandtheabilitytospeakandwriteinEnglishwithalevelofcompetencethatallowsforcomprehensioninboththeclassroomandclinicalsetting.Aninterviewwiththecandidatewillbeconductedtoassessthelanguagecapability.

2.MethodologyScholar（Biostatistics）

Mentor：

Nae-YuhWang,PhD.AssociateProfessorofMedicineandBiostatistics.Biostatisticsisacriticalandintegralpartofanyclinicalandtranslationalresearchproject.Thegoalofhavingabiostatisticssupportunitistoprovidebiostatisticalexpertiseinallstagesofaclinicalandtranslationalresearchstudy,includingprotocoldesign,studyconduct,dataanalysis,resultsinterpretation,andscientificreportpreparation.

ScholarQualifications:

ItisanticipatedthattheSYSUBiostatisticsMethodologyScholarwillassumealeadershiproleinestablishingthebiostatisticscapacitytosupporttheclinicalandtranslationalresearchenterpriseatSYSUaftercompletingtheprogramatJHMI.ThereforetheScholarshouldhaveaPhDorequivalentdoctoraldegreeinbiostatistics（preferred）,statistics,orsimilarquantitativesciencedisciplinessuchasEpidemiology,andhaveatleast3yearsofpostgraduateexperiencepracticingbiostatisticsinclinicalandtranslationalresearch.

ProgramContents:

TheScholarwillexploreimportantconsiderationshighlyrelevanttoestablishingabiostatisticssupportunitforclinicalandtranslationalresearch,includingidentificationofmissionsandgoalsoftheunit,considerationsoftypeofresearchtosupport,varioussupportservicemodelsandfinancialsupportmodelsforasustainableunit,andotheroperationalconsiderationssuchasfacultyandstaffdevelopment/retention,preparationfororservingonaDataSafetyMonitoringBoard（DSMB）,multicenterstudycoordinationandsupport,andstatisticalconsiderationsforsupportingthedesignandconductofrandomizedclinicaltrials（RCTs）.TheProgramwillprovidetheScholarwithhands-onexperiencethroughobservation,participation,anddiscussions.Inaddition,theScholarisexpectedtoattendseminarsandjournalclubdiscussionstohaveabetterappreciationofpracticalconsiderationsinclinicalandtranslationalresearchprojectsfromtheinvestigators’perspective.Arrangementsmayalsobemadeifsittinginadvancedstatisticaltrainingcoursesisdesired.EmphasiswillbeplacedonresponsibleresearchethnicsandconductthroughouttheProgramincludingparticipationintrainingcoursesasappropriate.

Theprogramwillcoverthefollowingtopics:

A.MissionsandGoalsofaBiostatisticsCore

1.Academic:

research（e.g.,cuttingedgestatisticalmethodsdevelopment）,education

2.Service:

collaborationand/orconsultation（state-of-the-artmethodsapplications）

3.Hybrid:

B.TypesofResearchtoSupport

a.Settings

1.HumanSubjects:

clinical,community-based,laboratory-based,database/electronicmedicalrecord（EMR）-based

2.AnimalModels:

b.StudyDesigns

1.Experimental:

laboratory,RCTs

2.Observational:

casereport,caseseries,cross-sectional,case-control,perspectivecohort/longitudinal

3.Criticalreview/synthesis,meta-analysis.

C.SupportModels

1.Collaborationvs.Consultation

2.Centralizedvs.Embedded

3.Hybrid

D.FinancialModels

1.Centrallybudgeted（freeservices）

2.Fee-for-Service

3.Hybrid

E.OtherOperationalConsiderations

1.FacultyandStaffDevelopment/Retention（continuingeducation,careerpaths）

2.DSMB

3.RCTs

4.MulticenterStudies

F.PracticalConsiderationsinClinicalandTranslationalStudies:

fromtheInvestigatorsProspective

1.JournalClubs

2.Seminars

3.ResearchProjectMeetings

G.BiostatisticianasanObjectiveAdvisortotheResearchTeam

1.ResearchEthics

2.ResponsibleResearchConduct

3.ReproducibleResearch

EvaluationofScholarPerformance

Asafinalproject,theScholarwillbeexpectedtodeviseandsubmitadraftplantoenhancebiostatisticssupportforclinicalandtranslationalresearchatSYSU,usingknowledgeandexperiencegainedduringtheProgramatJHMI.ThisplanmaybejointlyevaluatedwithSYSUleadership.

3.MethodologyScholar（Biospecimen）

Mentor:

JamesJ.Potter.PI/PDofTheTranslationalResearchEnhancementCore（TREC）ofTheHopkins-ConteBasicandTranslationalResearchCoreCenter

TheoverarchinggoaloftheTranslationalResearchEnhancementCore（TREC）istoprovidetheexpertiseandinfrastructureforcosteffectivetissueandclinicaldatacollectionthatmeetsBestPracticesthroughtheestablishmentofuniformStandardOperatingProcedures（SOPs）topromotescientificadvancesby,andscientificinteractionsamongCoreusers,collaborativeinvestigatorsandyounginvestigators,withouteachinvestigatorhavingtoinvestintheequipment/resourcesortoindividuallyworkoutthespecificSOPs.

Thecaptureofhighqualityspecimenswithassociatedclinicalannotationanddataanalysesenhancesthevalueofthespecimensforboththeinitialstudiesandalsoforfuturestudies.Toaccomplishthisgoal,itisimperativethatthevariousdatasystemsusedintranslationalandclinicalresearchbeinterlinkedandthatdatabeanessentialcomponentofhighqualitybiospecimens.TheTREChasthereforeemphasizedandfacilitatedthedevelopmentofintegratedsystemsassociatedwithbiospecimens,andhenceallrelevantassociateddata.

TheTRECconsistsofaClinicalResearchUnit（CRU）andaTissueBank（TREC-TxB）.TherolesoftheCRUare:

patientidentification,patientrecruitment,facilitationofpatienttrials,translationalresearchandbasicresearchthroughcreationofapatientregistryanddatabase.TherolesoftheTREC-TxBare:

toestablishBestPractices（BP）andStandardOperatingProcedures（SOPs）forthecollection,annotation,processing,storage,management,distribution,andethicaluseofspecimens（includingbloodandtissuespecimensandassociatedisolatedDNA,RNAandprotein）,andtoprovideaccesstospecimensbyinvestigators.

TheFellowfromSunYat-SenUniversitywillbeinstructedandwillactivelyparticipateinthefollowing:

A.SpecimenManagementandCollection

TheFellow:

∙WillbecomeacquaintedwithallBiorepositoryBestPractices（BP）andStandardOperatingProcedures（SOPs）

∙WillworkcloselywiththeTREC-TxBtechniciantobecomeexpertintheuseofbiorepositorysoftwareforspecimenmanagement

∙Willlearnallproceduresforthecollection,annotation,processing,storage,management,distribution,andethicaluseofspecimens

∙Willconductqueriesnecessarytoidentifyspecimensforstudy,especiallyspecimenslinkedtoclinicalannotation,suchaspathologyreports

∙WillinteractwithPrincipalInvestigators（PIs）,nurses,studycoordinators,andtechnicianstoseehowstudiesaredesignedandBPsandSOPsimplementedtoensurethatalllaboratoriesfollowunifiedSOPsforalltissuestobecatalogedandstoredinthebiorepository

B.Allequipmentandsuppliesessentialforspecimencollectionandstorage:

TheFellowwillbecomefamiliarwithallbiorepositoryequipmentanditsproperfunctionanduse,including,butnotlimitedto:

∙BarcodePrinters/Scanners-1and2-dimensionalbarcodealgorithmsforlabels.Usingbarcodesoftwareforproperlabelformattingthatiseasilyqueriedbyinformaticsapproachesforcohortandspecimendiscoverysu