Abstract
Using ODM-XML as the instrument to represent the SDTM annotated case report form (CRF) as both machine readable and human readable metadata for specification and documentation yields vast savings in time, cost, effort, and aggravation over other ways of producing these documents. By creating the human readable versions by simply adding a translating style sheet to the ODM-XML in exactly the same ways as the familiar creation of the human readable Define-xml, those savings are self-evident as the document creation becomes completely automatic. Additionally, the style sheet automates the cumbersome task of creating links between the define-xml document and the SDTM annotated CRF document, provided the SDTM origins in the define-xml are created as named destinations. By creating one document (the PDF portable document format version) from the other (the XML version) via validated code, multiple control and verification activities can be reduced to just a few samples.
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