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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.

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.

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 ...