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Standards and the Patient - Dr Kush comments on the new stream at the North American Interchange

The second session on Thursday 4 November of the CDISC Interchange was comprised of four speakers who brought a true patient perspective and patient-oriented value to the picture of developing standards.  This session was chaired by David Handelsman of SAS, CDISC Advisory Board Representative to the Board Strategy Committee. 

The State of the CDISC Union: Creating Value and Ensuring the Future for CDISC by Dr. Rebecca Kush

“…..here’s the thing:   if I give my song away to 20 people and they give it to 20 people, pretty soon they know me and my value as a creator is dramatically enhanced.”
“The best way to raise demand for your product is to give it away.”

Both of these quotes, which I used to open my presentation at this year’s North American Interchange, were from John Perry Barlow--- the first as the lyricist for The Grateful Dead in the ‘70s and the second for Wired Magazine in 1994.

Round Table Discussion Groups or How to Feedback your Experiences to CDISC - by Chris Decker

Chris Decker writes a guest Blog about the forthcoming Round Table Discussion Groups to be held at this year's North American Interchange. He explains who should attend and the importance of your input to the CDISC standards.

Japan, Part 3 of CDISC in Asia by Rebecca Kush

In the final part of Dr. Kush's blog series, she arrives in Japan for the Interchange to round off an exciting and demanding two weeks. 

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. 

Dr Rebecca Kush - Reflections on an excellent Interchange

Reflecting on the recent European CDISC Interchange, the phrase that reverberates in my mind is “Standards Everywhere”.  This is a credit to Dr. Paul Avillach, who asked to use my camera on Friday evening as half a dozen of us (who stayed through the bitter end to teach or participate in the CDISC Healthcare Link Course and the CDISC-HL7 Tutorial) ...

Clear Messages from FDA CDER and CBER

by Dr. Rebecca Kush

There are some very clear messages coming from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).  As of a meeting with CDER and CBER Representatives and the CDISC Executive Committee on 1 February ....

Rebecca Kush - FDA Messages from the Interchange: Use CDISC Standards Now

In the prior CDISC Blog, Dave Iberson-Hurst explored the ‘disappearing’ timelines for the HL7 transport mechanisms for CDISC content.  Since these HL7 standards (which by the way will be co-owned by CDISC and HL7 if and when they are ready) are not yet available nor tested, what does FDA want to see now (TODAY) when it comes to data standards? ...

Rebecca Kush, 'What is a Standard?'

The HHS Workshop on 15 October was entitled “Identifying Opportunities to Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange”.  Notice that the word “Standard” is not mentioned; this was intentional.  Some of you may ask why?  
I have been informed many times that the word ‘standard” connotes such ideas as rigidity, stifling creativity, inhibiting innovation. There are indeed many different types of standards (from a sort of flag, to a type of rather mundane beef to a standard operating procedure)...