CDISC 2013 Asia-Pacific Interchange2013亚洲太平洋互通立交

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1、CDISC2013Asia-PacificInterchange“StreamliningGlobalResearchthroughStandards”18-22February2013FairmontSingapore&SwissotelTheStamfordSingaporeSPONSORS____________________________________________________________________DiamondSponsor:RubySponsor:EmeraldSpons

2、ors:INTERCHANGESCHEDULE____________________________________________________________________CDISCOfficialAuthorizedEducationalTrainingMONDAY,18February201309:00-17:00SDTMv3.1.3Theory&ApplicationCourse(Day1ofa2-dayclass)Instructor:PeterVanReuselTheStudyData

3、TabulationModel(SDTM)isaspecificationforthesubmissionofpre-clinicalandclinicaldatatotheU.S.FoodandDrugAdministrationinsupportofmarketingapplications.Thistwo-daycourseconsistsof:AdetailedreviewofSDTMconcepts,SDTM-baseddomainmodelsforhumanclinicaldata,rela

4、tionshiptablesandtrialdesignAdiscussionofcommonimplementationissuesExercisesincludingtheannotationofCRFsandthecreationofdatasetsthatreinforceattendees’understandingoftheSDTMandtheSDTMImplementationGuideforClinicalData09:00-12:00ControlledTerminologyImpl

5、ementationCourseInstructor:BronKislerCDISCControlledTerminologyisasetofstandardvalueliststhatareusedthroughouttheclinicalresearchprocessfromdatacollectionthroughanalysisandsubmission.Thishalf-daycoursewillcover:BriefhistoryofCDISCterminologyPrimaryobjec

6、tives,guidingprinciplesHowterminologyisdevelopedandmaintainedTheImplementationGuideBasicsofusingterminologyAdiscussionofcodelistextensibilityAccessingcontrolledterminologyRequestingnewtermsTUESDAY,19February201309:00-17:00SDTMv3.1.3Theory&Applicatio

7、nCourse(Day2ofa2-dayclass)Instructor:PeterVanReusel09:00-17:00HealthcareLinkInstructor:LandenBainHealthcareLinkfocusesonthemissionofinteroperabilitybetweenhealthcare(theEHR)andclinicalresearch.CDISCandIntegratingtheHealthcareEnterprise(IHE)havecreatedthei

8、nauguralworkinglinkbetweenEHRsandclinicalresearchsystems.ThisisaccomplishedthroughuseoftheCDISC/IHEdevelopedintegrationprofile,RetrieveFormforData-Captureprofile(RFD),alongwithCDISCstandardstocollectrelevantdatafrom