CDISC Blog  filter by tag: Standards,

FDA CDER Data Standards Plan V 1.0 and PDUFA IV IT Plan Update Released By Dr. Rebecca Kush

Two new documents relevant to CDISC have now been posted to the FDA website and one announced in the Federal Register.  In this blog are a few highlights that I have pulled from each of the documents…but, please read them yourselves and  please sign up to attend the webinar on 29 June to hear directly from CBER and CDER representatives, Amy Malla and Dr. Chuck Cooper.

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? ...

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

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 ...

Rebecca Kush, CDISC & the Standards Landscape

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...

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)...