CDISC Blog filter by tag: Protocol,
February 8, 2010 at 4:26 AM by cdisc
Diane Wold of GSK gives her personal insights into the Protocol Representation ModelThose 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 ... read more...
Tags: SDTM, Protocol, ODM, CTR&R BRIDG,
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February 1, 2010 at 8:07 AM by cdisc
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 ... read more...
Tags: Protocol, Trial Design, WHO, BRIDG,
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