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CDASH – SDTM Mapping

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  1. CDASH – SDTM Mapping Kurt Hellstern German CDISC User Group Meeting Berlin, 19.Feb.2009

  2. How to Name CRF Fields? • No requirements in ODM • Container for precise definitions • Re-usability in later steps of the data processing Think backwards – start at the end. Why not as near to SDTM names as possible?

  3. Why Two Standards? • CDASH • Recommended standard for the collection of data • … from a clinical, scientific and regulatory perspective • SDTM • (Mandatory?) standard for the submission of data • …from an analysis and review perspective • overlapping • Field/variable names and attributes if data are identical, e.g. RACE, AETERM, EXTRT, EXDOSE, ect.

  4. CDASH SDTM Fields Variables CDASH SDTM Field in CRFVar in AE DomainOther Source AEYN -- AETERM AETERM AESTDAT AESTTIM --AEDY derived AESEV AESEV AEREL AEREL AESTDTC AE: Apparently a 1:1 Relation 1:1

  5. AEYN No Var in SDTM Start Time End Time 10:00 10:00 14:30 22:00 … not at all! AETERM AESTDAT AESTTIM AEONGO No CRF Field Look-up derived AETERM AESTDTC AEENRF AESTDY

  6. VS Domain Field in CRFVar in VS DomainAdd. Source DIASBP VSTESTCD metadata VSTEST metadata VSORRES VSORRESU VSORNRLO look-up table VSORNOHI look-up table VSDTC visit header: VISDAT --VSDY derived

  7. WEIGHTRESP HR SYSBP DIABP VISDAT derived VS Domain – Single Items in ODM

  8. derived X sitting VISDAT derived VSTEST VSORRES VSORRESU VSPOS VS Domain – Table Items in ODM

  9. Other Domains? • Trial design: not much info entered on CRF’s • LB: How to load from labs using the LAB model • DA/EX: single tablet count in CRF • Detail in DM: USUBJID • etc.

  10. Conclusion • Starting point for a metadata repository • Increasing clarity of our communication • Don’t hesitate to use CDASH, only beacause it does not match 100% your needs • Only practical experience brings us forwards

  11. Thank you for your attention kurt.hellstern@hands-on.ch