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  • Define.xml

    ACRONET

    The efficient preparation of Specification and its conversion into Define.xml on the process

    of statistical analysisTakashi Kitahara, Masataka Higashijima

    Biostatistics Department ACRONET Corporation

    Yoshitake Kitanishi, Yuki YoshidaBiostatistics Dept. SHIONOGI & CO., LTD.

  • Define.xmlDefine.xml

    CDISC FDAADaMDefine.xml

    2

  • Overview Figure

    3

    CDISC

    AnalysisDataset

    ADaM

    TFLsTFLsTFLs

    Define.xml

    StandardMetadata

    CRT-DDS

    SDTM

    SDTMDataset

  • CDISC

    4

    CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

    The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

    http://www.cdisc.org/

  • CDISC

    5

    (FDA)

    (CRO)

  • CDISC

    6

    PR()

    CDASH()

    SDTM()

    ADaM()

    CRT-DDS()

    Other

  • ADaM

    7

    FDA

    SDTM

  • ADaMSDTM

    8

    SDTM

    CRF

    CRF SDTMData

    ADaMData

    Analysis-Ready

    TFLs

    PC

  • 9

    SAS

  • ADaM

    10

    TFLs

    ADaMSDTM-ADaM

  • ADaM

    11

    LB

  • Define.xml

    12

    XML XML

    Extensible Markup Language

    XML

  • CRT-DDSDefine.xml

    13

    Define.xmlCRT-DDSFDA

  • Define.xml

    14

    AnalysisDataset

    TFLs

    Specifications Define.xml

    xsl file (Style Sheet)

    XML

    xsd File

    dateyyyy-mm-dd

    SAS Programming

    xml

  • CDISC

    15

    20062007FDA

    CDISCSDTMADaMFDA

    CDISC

    ADaMVersion2.0Version 2.12009.12.17

  • Define.xml

    16

    CDISCDefine.xmlSASDefine.xml

    CDISC

    ADaMInput

    Define.xml

  • 17

    SAS SpreadsheetExcel

    ADaM

    Define.xml

  • 18

    SAS SpreadsheetSAS

    AnalysisDataset

    Specifications

    Define.xml

  • 19

    Pros

    Define.xml

    Cons Define.xml

  • (Cons)

    20

    AnalysisDataset

    Define.xml

    Specifications

    Specifications Define.xml

    AnalysisDataset

    Define.xml

  • 21

    ADaM

    ADaM

    ADaM

  • 22

    Specifications Define.xml

    xsd File

    SAS Programming

    xsl File (Style Sheet)

    The Latest Versionof ADaM Metadata

  • 23

    Define.xml

  • /

    24

    pdf

    pdfpdf

  • /

    25

    Define.xml

    Define.xml

    Define.xml

  • /

    26

    xml

    Define.xml

  • /

    27

    Manual/Logical

    Manual/LogicalLogicalExcelVBA

    Specifications Check

    Manual Logical (Excel )

  • 28

    Define.xml

    1

    CDISC

  • 29

    Define.xml

    Define.xml

    Define.xmlxml

    or

    Define.xml

  • 30

    ADaM Analysis Data ModelCDASH Clinical Data Acquisition Standards HarmonizationCDISC Clinical Data Interchange Standards ConsortiumCRT-DDS Case Report Tabulation and Data Definition

    SpecificationFDA Food and Drug AdnimistrationPR Protocol RepresentationSDTM Study Data Tabulation Model

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