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CDISC Blog  filter by date: November 2009

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The FDA, HL7 and a Disappearing Timeline

November 19, 2009 at 8:38 AM by cdisc

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 ...


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TagsSDOs, HL7, PDUFA, FDA, CDER, CBER,



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Landen Bain - Healthcare Link, More than Learning ...

November 18, 2009 at 9:17 AM by cdisc

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 ...


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TagsHL7, EHRs, Healthcare, RFD,



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An evening with the Sharks!

November 12, 2009 at 2:30 PM by cdisc

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.

 


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TagsInterchange,



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Interoperability ... the Value of Standards - Live from the CDISC Conference

November 11, 2009 at 10:29 AM by cdisc

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 ...

 


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TagsStandards,



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Rebecca Kush: Live from the Conference - the Global Update

November 11, 2009 at 12:26 PM by cdisc

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 ...


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TagsStandards, FDA



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Landen Bain - Awards, Phenotypes and EHRs, all in a day's work.

November 10, 2009 at 3:36 PM by cdisc

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 ...


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TagsEHRs,



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Chris Tolk, Reports from FDA at White Oak

November 6, 2009 at 8:57 AM by cdisc

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 ...


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Tagsalzheimer's, CDISC, SDS CDER, therapeutic, FDA,



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Rebecca Kush, CDISC & the Standards Landscape

November 5, 2009 at 5:57 AM by cdisc

ISO Pic

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...


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TagsBRIDG, HL7,Standards, ISO,



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Rebecca Kush, 'What is a Standard?'

November 4, 2009 at 4:12 AM by cdisc

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)...


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TagsStandards, CDASH,



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Rebecca Kush, Bringing the Puzzle Together

November 3, 2009 at 12:07 am by cdisc

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...


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TagsBRIDG, Terminology, CDISC, FDA, SHARE, LAB,



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