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German Speaking CDISC User Network

German Speaking CDISC User Network. CDISC European Interchange 22 April, 2008. jhoffman@wabansoftware.com. Framework. CRF. Raw Data. Analysis Ready Data. Results. Protocol / Statistical Analysis Plan. Example of how SDTM, define.xml and ADaM fit together.

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German Speaking CDISC User Network

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  1. German Speaking CDISC User Network CDISC European Interchange 22 April, 2008 jhoffman@wabansoftware.com

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

  23. Questions?Thoughts?Comments?uestions?Questions? jhoffman@wabansoftware.com

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