Knowledge and Data Management White Papers
The Electronic Project: Effectively Using Metadata Throughout the Project Life Cycle
Overview The rapid, reliable, and cost-effective production of FDA deliverables is the Holy Grail of pharmaceutical companies and Contract Research Organizations (CROs). Difficult to achieve in a "Calm" environment, they become even more problematic as statisticians, programmers, and project managers edge closer to the maelstrom that is the submission date. The potential for miscommunication within the project team increases, seemingly exponentially, thus making the need for robust programming tools and practices critical. This paper describes the metadata tables and applications in detail. The paper demonstrates the ubiquity of the metadata by following its uses in the life cycle of one part of a submission package, namely, creation of industry standard (CDISC SDTM) compliant Domain datasets and their accompanying documentation, define.XML.
| Publisher | SAS Institute | File Format | |
|---|---|---|---|
| Date Published | May 2007 | Downloads | 6 |
| Format | White Papers | ||
| Topics | |||
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