Why don't you Define-it
Nick De Donder · 2014
Define was first released by CDISC as version 1.0 in 2005 and has been an integral part of FDA submissions ever since. However, the Define.xml has greater potential than to be used for submissions only. It could potentially allow study metadata to be used for improving study design and database set-up, standardizing metadata between CROs, vendors and sponsors, it can be checked against database structure and content for validation purposes and is an integral part of any FDA submission. Indeed, in recent years BDLS has noticed that sponsors are increasingly moving towards a metadata-based approach of data management (data collection and ultimately conversion to SDTM). In view of this, BDLS has developed the « Define-it » tool, an easy way of generating Define.xml version 1.0 and Define.xml version 2.0 from study specifications, and of converting Define.xml version 1.0 to Define.xml version 2.0.