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1 Dec 2009

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? ...

19 Nov 2009

It might not have been a presidential debate but the closing session at
the North American Interchange was no less intriguing. The session was
an FDA panel that opened with a speech from the FDA Deputy Commissioner
Dr Sharfstein

18 Nov 2009

Fifteen attendees and presenters spend Friday the 13th teaching,
learning, and sharing concepts around CDISC’s healthcare link project. 
This is the second time that CDISC has presented a training session on
healthcare link, the first being at the Japan Interchange in July of this year ...

12 Nov 2009

The CDISC Interchange rounded off the first day with an evening social event at the National Aquarium. And what an event it was, with the food and beverages organised across the various levels of the aquarium, attendees were able to see a variety of interesting animals, including sharks, rays and a fantastic jellyfish exhibit.

Rather than write about it ... take a look at the wonderful photos taken by Pierre-Yves Lastic.


11 Nov 2009

Dr. Rebecca Kush gave a compelling and engaging update on CDISC's global activities over the past year. Firstly, she thanked the members of the CDISC Advisory Board (CAB) who had developed the program for this year's conference and highlighted the new demonstrations that are taking place in the exhibition area during the event ...

11 Nov 2009

The CDISC conference is underway with the opening session and whilst the presentations were diverse, all of the speakers emphasised the importance of standards and the value they bring to medical research ...


10 Nov 2009

The NIH sponsored symposium "Widening the use of EHR data for Clinical
Research" took place on October 30, at the end of the Clinical and
Translational Science Awards (CTSA) face-to-face meeting on the NIH
campus in Bethesda, MD.  NIH manages forty-six awards in this program,
and the CTSA sites represent a cross-section of the high-end academic
medical centers in the US. So a face-to-face meeting of CTSA sites
brings together a broad spectrum of academic medical center informatics
types ...

6 Nov 2009

I attended the Coalition Against Major Disease (CAMD) Coordinating
Committee Meeting at the FDA’s White Oak Campus this week. The initial
goal of CAMD is to define clinical data standards and establish a
pooled database of the control group of pharmaceutical clinical trials
in order to develop quantitative disease progression models for both
Alzheimer’s and Parkinson’s disease ...

5 Nov 2009


The International Standards Organization (ISO) recently held one of its
twice-yearly meetings in Durham, North Carolina. Past meetings CDISC
attended were in Istanbul, Turkey; Goteborg, Sweden; Edinburgh,
Scotland. Here you can see one of the banners at the Durham meetings, thanks to
Bron Kisler for the photo...

4 Nov 2009

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)...