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 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

5. … 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

6. 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

7. 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

8. 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

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