Mark Wheeldon presented at PharmaSUG Annual Conference 2014 in San Diego, giving an overview of Define-XML.
Historically, Define.pdf was used as a submission deliverable to enable FDA reviewers to understand the content of submitted proprietary datasets. Define-XML was introduced by CDISC as a machine-readable alternative, and this has replaced Define.pdf as a mandatory part of an eCTD-based FDA submission.
Define-XML is still often seen as an afterthought, only produced when datasets are ready to be submitted. Read on, though, and find out just how versatile this under-appreciated standard can be.
This presentation explains:
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