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Knowledge and Data Management White Papers

The Second CDISC Pilot Project: A Metastandard for Integrating Databases

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knowledge and data management

Overview The first CDISC SDTM/ADaM pilot project created a test submission of one study to the FDA using CDISC data and metadata standards, in order to test that these standards meet FDA requirements (described in a paper Greg Steffens presented at SUGI 2007). The second CDISC pilot project objectives are to test the value of CDISC standards to create integrated databases (IDBs) and the new FDA safety review guidelines. This paper focuses on the first objective and describes the collection and use of metadata in the second pilot and a very important drafted extension to the define.xml schema that supports row-level metadata and fills a gap in the metadata schema identified in the first pilot project.

Further White Paper Details
Publisher	SAS Institute	File Format	PDF
Date Published	February 2009
Format	White Papers
Topics	Knowledge and Data Management

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