Just like Dr. Pepper, Define-XML is so misunderstood. There’s a common misconception among CDISC users that it is simply a way to document what datasets look like. Sure, Define-XML can be used to document the names and labels of dataset variables, and it can document what terminology is used. It does that brilliantly. But thinking of Define-XML solely as a dataset descriptor does this standard a massive injustice.
For many years companies have adopted CDISC, in the belief that the only reason to do so was due to an impending regulatory requirement. Regulation has aided the adoption of CDISC standards, but in many cases, we’ve found that this has fueled the legacy to SDTM conversion market and many sponsors have been left wondering where the long term benefit of standardization really lies.