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CDISC Blog filter by tag: ADaM,
August 19, 2010 at 9:17 AM by cdisc
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. read more...
Tags: JPMA, Primer, J3C, MHLW, SDTM, UMIN, ADaM, Hamamatsu, K3C, CDASH,
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February 10, 2010 at 7:26 AM by cdisc
by Dr. Rebecca KushThere 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 .... read more...
Tags: ADaM, CDASH, Members, CDER, SDTM, CBER, FDA,
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December 1, 2009 at 9:08 AM by cdisc
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? ... read more...
Tags: Ethics, FDA, define.xml, Standards, ADaM, CDASH, SDTM, HL7,
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