A new perspective on efficient SEND data creation using define-XML file

Abstract

The FDA has mandated submission of standardized electronic data in compliance with CDISC SEND. In SEND creation process, the creators and their sponsors have often suffered the variation of SEND data specification, which would cause the difficulties in using the data for the integrated study analysis and force the creators to inefficient QC tasks. Define-XML is a potential tool to resolve this issue. In this presentation, we will introduce a mock-up template for preparing a Define-XML, and propose its effective use for communicating the specification between the creators and sponsors.