This is the News

Back in February of this year at the CDISC Intrachange the teams gathered in Washington DC on a cold and wet Tuesday morning for a series of cross-team meetings. We generally start the Intrachange with a plenary meeting that allows everyone to meet and say hi and to permit me and the team leads to set the scene for the coming three days. I remember standing in front of the 100 or so folks and presenting a single slide that contained just a series of words that I had chosen to illustrate the themes for CDISC’s technical work in 2009. To me three of those words, Start, Finish and Solve are what the Intrachanges are about; what new work are we starting, what work can we complete or what are the issues we need to solve to allow us to finish a piece of work.

At the time of the Intrachange in February we had already seen the annual release of the CDISC glossary with Version 7 being published both on the CDISC website and in Applied Clinical Trials. The month of March saw the publication of SDTM V1.2 and the associated Implementation Guide (IG) V3.1.2 and in the same month SEND V3.0 Draft A was released for use as part of the FDA/CDISC/Industry SEND pilot.

In April and May we saw a flurry of activity as the first version of the new Protocol standard V1.0 was released for public review, work started on support for Devices in SDTM and CDASH as work commenced on the HITSP EHR and Clinical Research interoperability specification.

The ADaM team released V2.1 of the standard and the first version V1.0 of the IG for public comment in the summer and as we approached the CDISC interchange in November BRIDG R3.0, ODM V1.3.1 and a substantial terminology package were all released for public comment. Around the same time the FDA announced the inclusion of SDTM V3.1.2 in their Study Data Specification and their acceptance of V3.1.2 submissions, while HITSP released the draft of IS/158, the  Clinical Research Interoperability Specification for public comment.

Within the last week the XML Technology team have released a guidance document on XML schema validation for define.xml to assist industry with issues in submitting define.xml to the FDA. This document was written in response to some issues uncovered during testing on SDTM data submissions being undertaken by CBER.

In parallel, CDISC has continued to work with Health Level 7 (HL7), ISO Technical Committee (TC) 215 and with Integrating the Healthcare Enterprise (IHE) on developing standards applicable to the clinical research domain and supporting the terminology needs of those projects. CDISC has also been starting to look at therapeutic area standards with partnerships in the areas of Cardiovascular, Diabetes, Parkinson & Alzheimer and Polycystic Kidney Disease.

In the next few weeks, we will see the CDASH V1.1 and the new CDASH User Guide (UG) V1.0 come out for public review and the formal release of the ADaM specification and the associated IG will take place before the end of the year.
And just to round off what is a pretty busy year the SHARE project has been proceeding with a significant amount of pilot work leading to a CDISC board decision to advance the project.

Looking back through the words, I see something like a dozen major items that CDISC will have posted for public comment or released at production status during 2009. This is an average of one a month. Given that the vast majority of the work within CDISC is undertaken by volunteers, this is a great achievement.

I want to finish by paying tribute to the volunteers, the team members and the team leads for their hours of dedication and effort. I would also like to thank their respective line managers and their organizations who allow them to be involved, who help CDISC by funding their time and their travel to such events as the Intrachange. Without them we could not deliver a product a month.

Dave Iberson-Hurst   
VP Technical Strategy