BACUN Fall 2009 Meeting Debriefing

The Boston Area CDISC User Network Fall 2009 Meeting Report

Sue Dubman's BACUN meeting held at Genzyme, Boston was an eye opener. Stephen J Ruberg PhD of Lilly went on about the slow pace of standardizing terminologies within the current CDISC "operational data model." That, volunteer teams that meet twice a month to plod through a particular medical/research domain to come up with common terms. He gave an example of the TB domain which took 18 months to determine some 80 or so standard terms to be used when defining TB related studies. That's not going to keep up with the new terms/concepts developed each minute in the scientific literature, much less define scientific concepts from the last million years of civilization. At least not in my lifetime. Useless. Shame too, because as Stephen pointed out, industry would like to have these standards. After all, we all agree it's a good idea. Trouble is, CDISC has taken the lead on this and they're not getting it done. He offered an "alternative?" ODM for getting this done. He also pointed out that Lilly has started their own repositories of terms, forms and such and has defined them in the latest CDISC spreadsheet style and he welcomes anyone interested to participate in adding or taking from their homespun repository. They used Formedix's ODM designer tool for the job. Mark Wheeldon, CEO? Of Formedix pointed out that this data is available on Codeplex somewhere. Have at it.