Since its inception in 2000, the Clinical Data Interchange Standards Consortium (CDISC) has developed and supported globally-adopted data standards to improve clinical trial efficiency. Clinical data standards are now recognized as playing a vital role in the entire end-to-end clinical trial process, as well as bringing operational and time savings to the development of new drugs.
One of the most widely used standards today is Define-XML. Based on a recent poll, 71 percent of those currently using CDISC have implemented Define-XML.
This paper explores alternative uses of Define-XML: from study set-up through the production of CDISC Study Data.