CDISC Blog

Paralysis and Madness: The Road to eSource Enlightenment by Dave Iberson-Hurst

Dave Iberson-Hurst discusses the evolution of the recently released EMA guidance on electronic Source Data and the challenges associated with developing new ideas.

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. 

China, Part 2 of CDISC in Asia by Rebecca Kush

Yesterday, we posted Dr. Kush's experiences in Korea, today she and her two companions, Pierre-Yves Lastic and Sheila Leaman have reached China.  Here they meet with the CDISC China Advisory Council (CCAC), a new and important group. They also managed to visit one of China's most famous landmarks.

CDISC in Asia - by Dr. Rebecca Kush

During the month of July, Dr. Rebecca Kush spent two weeks building CDISC's relationships with 3 very different countries and cultures in Asia. Accompanied by Pierre-Yves Lastic (sanofi - aventis) and Sheila Leaman (CDISC), Dr. Kush found that the work was inspiring and the sights stunning.

Over the next 3 days, you can read about CDISC's presence on the global stage, as Dr. Kush reports from Korea, China and Japan.

CDISC SHARE – Progress Report by Rhonda Facile

By now, many of you have heard about the CDISC SHARE project.  For those of you that haven’t,   this new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model. In short we want to change the way we develop standards to an approach that focuses on precise definitions, terminology and metadata (BRIDG, datatypes, variable names, etc.) to take a date element/concept from the clinical protocol, through collection, analysis and submission.  To quote Dave Iberson-Hurst, CDISC is, “moving from the implicit world of data standards to the explicit world of data standards”.