A nalysis Da ta M odel (ADaM)

1. Analysis Data Model (ADaM) Case Studies Wouter van Wyk, 27 Sep 2012

2. Case Studies Specific to Basic Data Structure (BDS) With the increased adoption of the Analysis Data Model (ADaM) we are facing a shift in our approach to creating Analysis datasets, as we are encouraged to create records rather than adding additional variables as we might have in the past.  With these Case Studies I hope to address some of the questions around: Mapping multiple SDTM Variables to the same ADaM variable Creating derived records Multiple baseline definitions in the same ADaM domain

3. Mapping multiple SDTM Variables to the same ADaM variable • Finding domains • Eg. LB, VS, EG • **ORRES, **STRESN • Map to BDS • AVAL, AVALC • Multiple variables mapping to a single ADaM BDS Result variable • Traceability • SRCDOM, SRCSEQ, SRCVAR

4. Mapping multiple SDTM Variables to the same ADaM variable SDTM VS Dataset

5. Mapping multiple SDTM Variables to the same ADaM variable

6. Mapping multiple SDTM Variables to the same ADaM variable • Traceability • The property that enables the understanding of the data’s lineage and/or the relationship between an element and its predecessor(s). • Where did the data come from? • SRCDOM: Identifies the SDTM domain • SRCSEQ: Identifies the record in the SDTM domain • SCRVAR: Identifies the SDTM variable used to create AVAL/AVALC

7. Creating derived records • Derived Parameters • Test is not present in SDTM • BMI, BSA, • Calculated Creatinine Clearance • QTcF, QTcB • Derived Value • Test is in SDTM, but the record is not • Baseline, • Endpoint • Last Observation Carried Forward • Traceability • PARAMTYP vs. DTYPE

8. Creating derived records DTYPE LOCF

9. Creating derived records

10. Creating derived records • Duplicate the needed record • Populate DTYPE to indicate new record • Use something descriptive like, LOCF, BASELINE, ENDPOINT, WCCF • SCRDOM, SRCVAR, SRCSEQ populated as with original record • Do not modify SDTM variables

11. Creating derived records PARAMTYP

12. Creating derived records • Add records needed • New value for PARAM and AVAL • SRCSEQ, SRCDOM, SRCVAR will be NULL • AVAL did not have SDTM as source • SDTM variables can be populated as appropriate • Do not modify SDTM variables

13. Multiple baseline definitions in the same ADaM domain • Multiple definitions of Baseline • Last value prior to very first dose of active • Last value prior to Run-in • Last value prior to Double-Blind • Last value prior to Open Label • In case there is more than one definition of baseline, new rows must be created for each additional alternative definition of baseline • Some data redundancy is expected • BASETYPE

14. Multiple baseline definitions in the same ADaM domain CDISC ADaM IG v1.0 Table 4.2.1.11

15. Multiple baseline definitions in the same ADaM domain

16. Multiple baseline definitions in the same ADaM domain • Duplicate all records affected • Populate BASETYPE with something descriptive • SRCVAR, SRCDOM, SRCSEQ will be populated as records can be traced back to SDTM • Some data redundancy is expected

17. Summary • SRCVAR, SRCDOM, SRCSEQ used when multiple SDTM variables map to AVAL • E.g. **ORRES and **STRESN • DTYPE used when new record is created but AVAL is not modified. • E.g. LOCF • PARAMTYP used when new parameter is created and value of AVAL can not be traced back to SDTM • BASETYPE used when there are multiple baseline definitions that require additional records to be added

18. Questions?