SHARE Sightings at the CDISC International Interchange

SHARE wasn't only the theme of this year’s International Interchange, it was also a launch of sorts. CDISC has certainly talked about SHARE at past Interchanges, but this year’s dialogue had a different quality to it. This was largely driven by the fact that the wrappers were taken off the SHARE software, and attendees actually got a preview of what’s coming. We’re still talking about the vision for SHARE, maybe more than ever, but we’re also talking specific features and functions, as well as when we’ll begin using the application.

During the SHARE session on Thursday the SHARE Road Map was presented, the version of SHARE currently under development was demonstrated, and we saw how SHARE and CFAST fit together.  The release of SHARE R1 is planned for the first quarter of 2014. After initiating the project in 2007, and following a longish gestation period, the implementation is on target to deliver in a period of just under 6 months. We have a long way to go to fully realize the CDISC vision, but R1 is a substantial step in the right direction.

SHARE R1 is themed Machine-Readable Standards, and targets publishing CDASH and SDTM content in text delimited, ODM, and Define-XML formats. RDF exports are targeted for the second quarter of 2014. CDISC standards content loaded for R1 includes SDTM 1.2 (IG 3.1.2) and 1.3 (IG 3.1.3), CDASH 1.1, BRIDG 3.2 / ISO 21090, and all the CDISC Controlled Terminologies. SDTMIG 3.2 will be loaded shortly after the release. An initial example of Value Level Metadata will also be available.

It’s important to note that the standards will be loaded as they exist today. Just loading them into SHARE has immediately highlighted some opportunities for improvement, but SHARE doesn’t create standards content. SHARE provides a better platform for the standards teams to develop and manage standards content. It’s also important to highlight the fact that certain content won’t be loaded until R2, including ADaM, SEND, and Research Concepts. Research Concepts, for those that aren’t familiar with the term, define one or more pieces of related clinical data, and represent the foundation for the content described in SHARE. The Research Concepts are just beginning development, but they will play an important role in supporting improved standard development methods such as the new TA standards development process.


During the Interchange it was mentioned that “standards are infrastructure.” They’re not always exciting on their own, but they enable some exciting benefits. Well, SHARE is “infrastructure for standards” and, similarly, most of the excitement will be created by the new capabilities SHARE enables. R1 is a key step forward on a long and very incremental journey. I’m looking forward to a number of SHARE webinars and demonstrations in 2014, but more importantly it’ll be nice to start using SHARE R1.

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