Chapter 5: Case Report Tabulation Data Definition (Define-XML)

The Case Report Tabulation Data Definition Specification (Define-XML) transmits metadata that describes any tabular data set structure, such as the SDTM and ADaM data that we have been describing throughout this book. The FDA and PMDA requires Define-XML in addition to, and to describe in more detail, the CDISC SDTM and ADaM and data for drug submission as it improves the reviewer’s understanding of the entire data submission package. This chapter describes the process of generating a Define-XML file.

The following section describes some general concepts of XML code. We do not cover details of XML coding as the Define-XML format continues to evolve and can be created in a plethora ...

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