1 / 11

CDASH – SDTM Mapping

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

gayora
Télécharger la présentation

CDASH – SDTM Mapping

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related