Brave New World: How to Adapt to the CDISC Statistical Computing Environment
Jeff Abolafia, Frank DiIorio · 2011
Recent years have seen CDISC standards such as SDTM, ADaM, and CDASH evolve from “what a good idea” to “must have for an FDA submission.” That is, if you’re in the FDA submission business, you’re now also in the CDISC business. Viewing these standards simply as a collection of data structures and documentation requirements is tempting, but ultimately problematic. Their impact extends throughout the statistical computing environment of any organization dealing with the FDA.