German Speaking CDISC User Network

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German Speaking CDISC User Network

• CDISC European Interchange
• 22 April, 2008

jhoffman_at_wabansoftware.com
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Framework
CRF
Raw Data
Analysis Ready Data
Results
Protocol / Statistical Analysis Plan
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Example of how SDTM, define.xml and ADaM fit
together
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• 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

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Starting with the output and working backwards

• Two questions could occur to us
• How is Time to Event Calculated
• What is a Dermatological Event

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The Figure 14.1 is Listed in the Analysis Results
Level Metadata
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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
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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
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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
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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
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• 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

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SAP Define the Analysis / Output
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Specify the output
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Specify the Source Data
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Specify required variables and their calculation
method
Dermatological Event
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Specify required variables and their calculation
method
Time to Event
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An Extra Step Specify the Formal Expression for
the Calculation Method
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An Extra Step Specify the Formal Expression for
the Calculation Method
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Using define.xml as an executable
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Generate the ADaM dataset
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Generating the Submission Output
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Framework
CRF
Raw Data
Analysis Ready Data
Results
Protocol / Statistical Analysis Plan
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Questions?Thoughts?Comments?uestions?Questions?
jhoffman_at_wabansoftware.com