A concept for define.xml generated in SAS

Abstract

AbstractWhen submitting data to the FDA, a data definition file, describing the structure and contents of the data, is a mandatory deliverable. For data submitted in the CDISC SDTM format the define.xml as published by the CDISC define.xml team is the preferred type of a data definition file. Compared to define.pdf, the previous data definition file format, define.xml is more suitable for providing the different types of metadata required to adequately describe data in the SDTM format. An additional benefit of define.xml is its machine-readability. After Accovion successfully implemented an automated process for define.pdf in SAS®, building a SAS® based automation process for define.xml was the logical consequence. This paper illustrates the process chosen by Accovion to compile all the necessary metadata and build a define.xml as described in the CDISC Case Report Tabulation Data Definition Specification (define.xml) V1.0 Standard. And as this standard will evolve over the next years, it will briefly tou...