DM04
Implementing a Standardized Data Model – A Real Life Experience
Curtis B Wolf, DataCeutics
Paul Gilbert, DataCeutics
Patric Genyn, Janssen Pharmaceuticals

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 n eed 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 known as the Common Raw Data Model (CRDM) was to facilitate the sharing of data across multipl e 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. The actual data format generated in the CRDM forma t 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 CRDM uses components of the CDISC submission data model.