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. Why not as near to SDTM names as possible?

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.

CDASH SDTM Fields Variables AE: Apparently a 1:1 Relation 1:1 Field in CRF Var in AE Domain Other Source AEYN -- AETERM AETERM AESTDAT AESTTIM -- AEDY derived AESEV AESEV AEREL AEREL AESTDTC CDASH SDTM 1:1 CDASH SDTM Fields Variables

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

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

VS Domain – Single Items in ODM WEIGHTRESP HR SYSBP DIABP derived VISDAT VSTEST VSTESTCD VSORRES VSORRESU VSPOS VISITNUM VSDTC Diastolic Blood Pressure DIABP 70 mmHg Sitting 3 20090219

VS Domain – Table Items in ODM derived X sitting derived VISDAT VSTEST VSORRES VSORRESU VSPOS VSTEST VSTESTCD VSORRES VSORRESU VSPOS VISITNUM VSDTC Diastolic Blood Pressure DIABP 70 mmHg Sitting 3 20090219

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.

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

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