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Just Do It! Dave Iberson-Hurst reflects on the North American Interchange

It has been a week or so since I returned from the US Interchange and I thought it timely to write a short blog about the work that CDISC does and, more importantly, the people who, in the words of one rather well know sports goods manufacturer, Just Do It.

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. 

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? ...