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CDISC SHARE – Progress Report by Rhonda Facile

By now, many of you have heard about the CDISC SHARE project.  For those of you that haven’t,   this new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model. In short we want to change the way we develop standards to an approach that focuses on precise definitions, terminology and metadata (BRIDG, datatypes, variable names, etc.) to take a date element/concept from the clinical protocol, through collection, analysis and submission.  To quote Dave Iberson-Hurst, CDISC is, “moving from the implicit world of data standards to the explicit world of data standards”.

FDA, CDISC Standards and the Critical Path by Rebecca Kush

June has been a month full of interesting meetings, events and activities for CDISC.  In particular, Bron Kisler and I attended a set of meetings in the Washington, DC area 8-11 June while others within CDISC met face-to-face in Philadelphia to advance the CDISC SHARE project. 

Rebecca Kush, Bringing the Puzzle Together

November is suddenly upon us and I am wondering where the first 10 months of the year have gone. While welcoming the earlier sunrise (and the end of daylight savings, which brings no favors to those of us who live in the hotter areas nearer the equator), there is reason to reflect on what CDISC has done in the past 10 months of 2009 and where we are going in 2010. There have been many opportunities to do this recently...

Consensus through SHAREing!

Since I last wrote on the blog much has changed. As you may have noticed, we have a new website. This has taken a great deal of effort by the CDISC communications staff to get this developed and the content from the old site moved across. It took a little longer to get the blog up and running as part of the new site but we are there now.

The other day, I looked at one of my computer screens. My twitter feed started reporting...

The Impact of Shared Semantics

Last week, I had just returned from San Francisco after a face-to-face meeting about the CDISC work to build a repository of shared semantics. After a long trip home, I indulged in my interest in cycling and caught up with the Tour of Italy, the Giro d’Italia. The Giro, along with the Tour of Spain – the Vuelta – and the Tour de France are the three premier events on the annual cycling calendar. This year was the 100th running of the Giro and, after being out of professional cycling for three years, Lance Armstrong was competing in the event for the first time. Lance was there to raise awareness of his Livestrong charity and its work in fighting cancer. With Lance at the event the media interest exploded....

One Man's Metadata is ...

One of the main reasons for starting the CDISC blog was to improve the flow of communication from CDISC to the CDISC community. It is a feature of CDISC that the less we communicate the better the quality of the rumours. The problem we face is that however much we do actually communicate, we could always do more. This has certainly be true when I think about the CDISC HL7 project and some of the rumours that surround that work. However, more about that project in a later post ...