CDISC Interchange Europe 2011

We presented in Brussels at the Crown Plaza on April 12th for the CDISC Interchange Europe 2011 on the following topic.

Integration of Clinical Trial Data Standards
Part II. Models and Applications


Part I of this presentation focused on the process and content aspects of the clinical trial data standards integration effort at Genentech and Roche. This part of the presentation shows how the content is modeled, stored, and surfaced.

It provides an overview of the metadata models for the collection, tabulation, analysis, and concept definition of the clinical trial data elements based on the CDISC data standards and the W3C semantic standards.

It explains how this metadata is maintained, versioned, published, and stored in a metadata repository.

It demonstrates how the content is accessed by users through a web based interface and by applications through a set of web services.

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