1. German Speaking CDISC User Network
CDISC European Interchange
22 April, 2008

2. Protocol / Statistical Analysis Plan
Framework
CRF
Raw Data
Analysis Ready Data
Results
Protocol / Statistical Analysis Plan

3. Example of how SDTM, define.xml and ADaM fit together

4. “It is perfectly true, as philosophers say, that life must be understood backwards. But they forget the other proposition, that it must be lived forwards.”
Søren Kierkegaard

5. Starting with the output and working backwards
Two questions could occur to us:
How is “Time to Event” Calculated
What is a “Dermatological Event”

6. The Figure 14.1 is Listed in the Analysis Results Level Metadata

7. From the Analysis Level Metadata we can get to the SAP and the Supporting Dataset ADTTE
The Analysis Results Level Metadata also links to the Analysis Dataset Level Metadata
The Analysis Results Level Metadata links to a written description of “Time to Event” and “Dermatological Event” appears in the SAP

8. Use of Dataset and Variable Level Metadata
Analysis Dataset Level Metadata has the Analysis Variable Level Metadata and links to the computational method for “Time to event” COMP_ADTTE_TTP
…and also links to the source dataset, ADAE

9. Use of Dataset and Variable Level Metadata
The ADAE Analysis Dataset Level Metadata has the Analysis Variable Level Metadata for “Dermatological Event,” AEDERMFN and links to the appropriate computational method, COMP_ADAE_AEDERMFN

10. Use of Dataset and Variable Level Metadata  to the CRF
From “AEDECOD” we can go to the SDTM AE and its Variable Level Metadata
AEDECOD Variable Level Metadata links to the Annotated CRF

11. “It is perfectly true, as philosophers say, that life must be understood backwards. But they forget the other proposition,
that it must be lived forwards.”
Søren Kierkegaard

12. SAP – Define the Analysis / Output

13. Specify the output

14. Specify the Source Data

15. Specify required variables and their calculation method
Dermatological Event

16. Specify required variables and their calculation method
Time to Event

17. An Extra Step: Specify the Formal Expression for the Calculation Method

18. An Extra Step: Specify the Formal Expression for the Calculation Method

19. Using define.xml as an executable

20. Generate the ADaM dataset

21. Generating the Submission Output

22. Protocol / Statistical Analysis Plan
Framework
CRF
Raw Data
Analysis Ready Data
Results
Protocol / Statistical Analysis Plan

23. Questions?Thoughts? Comments?uestions? Questions?