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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 CDISC European Interchange 22 April, 2008 jhoffman@wabansoftware.com
Framework CRF Raw Data Analysis Ready Data Results Protocol / Statistical Analysis Plan
“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
Starting with the output and working backwards • Two questions could occur to us: • How is “Time to Event” Calculated • What is a “Dermatological Event”
The Figure 14.1 is Listed in the Analysis Results Level Metadata
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
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
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
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
“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
Specify required variables and their calculation method Dermatological Event
Specify required variables and their calculation method Time to Event
An Extra Step: Specify the Formal Expression for the Calculation Method
An Extra Step: Specify the Formal Expression for the Calculation Method
Framework CRF Raw Data Analysis Ready Data Results Protocol / Statistical Analysis Plan
Questions?Thoughts?Comments?uestions?Questions? jhoffman@wabansoftware.com