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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 ....

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 ...

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? ...

The FDA, HL7 and a Disappearing Timeline

It might not have been a presidential debate but the closing session at the North American Interchange was no less intriguing. The session was an FDA panel that opened with a speech from the FDA Deputy Commissioner Dr Sharfstein ...