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ADaM on a Diet. Preventing Wide and Heavy ADs. Dirk Van Krunckelsven Phuse 2011, Brighton. Standard Data – Clear benefits. Easier automation / tools Better communication about the data Reviewers Service Providers Partners Easier sharing and inheriting of work. - PowerPoint PPT Presentation

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  • Preventing Wide and Heavy ADsDirk Van Krunckelsven Phuse 2011, BrightonADaM on a Diet

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  • Presentation title in footer | 00 Month 0000*Standard Data Clear benefitsEasier automation / toolsBetter communication about the dataReviewersService ProvidersPartnersEasier sharing and inheriting of work

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  • Presentation title in footer | 00 Month 0000*SDTM and ADaM Submission formatsADaM datasets:Analysis Ready Focus on Key ResultsNot every listing in a CTR

    Use for other purposes than submission tooWork in (near) ADaM always

    Some companies: ADs for all deliverablesRetrospective vs. Prospective

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  • Presentation title in footer | 00 Month 0000*SDTM: Mature standardLots of standard domains availableSomething does not fit?Supplemental: --SUPPNew domain: Follow classification and pickEvent: --TERMIntervention: --TRTFinding: --TEST(CD)

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  • Presentation title in footer | 00 Month 0000*SDTM and ADaMSDTM Model: version 1.2IG: version 3.1.2

    ADaM (Dec 2010)Model: version 2.1IG: version 1.0

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  • Presentation title in footer | 00 Month 0000*ADaM: Two models, some draftsADSL Subject Level Analysis DatasetBDS Basic Data Structure

    Draft ADAEExtend to General Occurrences ADDraft ADTTEActually a case for BDS

    Nice examples document out just now

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  • Presentation title in footer | 00 Month 0000*ADaM: Info not described in the modelsA lot of information not described in the modelSubject Level InformationOften ends up in ADSLAdditional variablesOften copied to all other analysis datasetsCDER common issues documentThough: ADs for all outputs

    Bearing in mind: ADaM ADs not only for submissions ADs for all deliverables

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  • Presentation title in footer | 00 Month 0000*ADaM: Info not described in the modelsBaseline informationHeight WeightBMI Study specific, lab baselinesCategories of Baseline informationDiscontinuation ReasonsTreatmentStudyTreatment DurationSmoking, Drinking, other Risk Factorsdurations frequencies

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  • Presentation title in footer | 00 Month 0000*Plug it all onto ADSL?All such subject level information can go on ADSLNaming convention to adhere toWhat is still standard?Good communication?Very Wide ADSLAll other ADs become wideIf all copied overNot necessarily all, what to choose?

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  • *TRTDURHEIGHTBLWEIGHTBLBMIBL[LAB]BLDISSTREADISTRREAHEIBLGR1WEIBLGR1BMIBLGR1[LAB]BL1[LAB]BL2HEBLGR1NWEBLGR1NBMIBLGR1[LAB]BL1N[LAB]BL2NOTHERSDISSTREADISTTREATRTDURBMIBL[LAB]BLHEIGHTBLWEIGHTBLOTHERSHEIBLGR1HEBLGR1N

  • Presentation title in footer | 00 Month 0000*Can we standardize?Yes, in structureUse what we have availableBDSSupplemental structureCan standardize in content alsoGraduallyTerminologyApply Naming Convention as Terminology

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  • Presentation title in footer | 00 Month 0000*ADSLSUPPAdditional normalized dataset:ADSLSUPP: Supplemental Subject Level InformationorBDSL: Basic Data Subject Level

    Same principle as SupplementalUse BDS as model

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  • Presentation title in footer | 00 Month 0000*ADSLSUPP

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  • Presentation title in footer | 00 Month 0000*ADSLSUPP

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  • Presentation title in footer | 00 Month 0000*ADSLSUPP

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  • Presentation title in footer | 00 Month 0000*ADSLSUPP is Standardized StorageMerge with other data is trivialSubject Level STUDYID USUBJIDSee paper

    All information readily available for Output generationFurther exploration: sub setting, grouping, etc.Submit also?Reviewer may be interested as well

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  • Presentation title in footer | 00 Month 0000*Lets talk ADaM!CDISC ADaM teamMore drafts, examplesHard workVolunteersReviewer Acceptance!?SDTM for analyses?Cf. Chuck Coopers Keynote presentationPhuse 2011:

    SDTM (10)ADaM (6)

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