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The State of the CDISC Union: Creating Value and Ensuring the Future for CDISC by Dr. Rebecca Kush

“…..here’s the thing:   if I give my song away to 20 people and they give it to 20 people, pretty soon they know me and my value as a creator is dramatically enhanced.”
“The best way to raise demand for your product is to give it away.”

Both of these quotes, which I used to open my presentation at this year’s North American Interchange, were from John Perry Barlow--- the first as the lyricist for The Grateful Dead in the ‘70s and the second for Wired Magazine in 1994.

Reasons to Celebrate - The Protocol Representation Model

Diane Wold of GSK gives her personal insights into the Protocol Representation Model

Those of us who started working toward a structured protocol representation in 2003 were motivated by the feeling that there had to be a better way to communicate information about a study than a text document.  The protocol is at the heart of clinical research, so it's just not effective or efficient for all the parties involved to extract data from text ...

Protocol Representation Model V1.0 - Now Released!

The CDISC Protocol Representation Model (PRM) Version 1.0 is released and available at http://www.cdisc.org/protocol.

The Model contains study protocol concepts such as Trial Design, Eligibility Criteria, and addresses the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries.  Additional protocol domain areas, activities, definitions ...