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Creating Define.xml 2.0 with OpenCDISC
A CDISC Define.xml file is central to any electronic FDA submission — yet FDA reviewers report that the majority they see are rife with problems. They don't have to be. OpenCDISC Enterprise 2.5 gives you the tools to create FDA-compliant Define.xml 2.0 files in a snap. This enables easier transmission of metadata for CDISC SDTM, SEND and ADaM ...
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