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Implementing a Standardized Data Model – A Real Life Experience
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BibTeX
@MISC{Gilbert_implementinga,
author = {Curtis Wolf Paul Gilbert and Patrick Genyn Janssen Pharmaceutics},
title = {Implementing a Standardized Data Model – A Real Life Experience},
year = {}
}
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Abstract
As organizations strive for gains in efficiencies in processing and using clinical information, the need for a common set of terminology and data standards becomes vitally important. As partnering and use of outside organizations become more common, this need takes on an even broader challenge. One such company was the setting for a project we will be discussing in this presentation. The intent of the project was to facilitate the sharing of data across multiple platforms and systems thereby enhancing and creating efficiencies in the data management, review and reporting process and enabling sharing of resources and unique developments across the organization. This model is being used as the basis for the designing care report forms (CRFs), clinical databases and analysis files and consequently for Case Report Tabulations (CRTs) for submission to the FDA and other regulatory agencies, as well as the data source for a variety of other reporting tools. The actual data format generated in the Standard Data Model format was not confined to one type but could be represented in SAS Data files, ASCII text files, Oracle tables, or XML as a future implementation. The Standard Data Model uses components of the CDISC submission data model.
Keyphrases
ascii text file clinical database case report tabulation analysis file future implementation clinical information reporting tool common set data management cdisc submission data model designing care report form data standard reporting process actual data format regulatory agency unique development data source outside organization multiple platform standard data model format standard data model sa data file
