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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 ...

Julie Evans at ISO in North Carolina

I’m just back from the ISO TC 215 Joint Working Group meeting in Durham, North Carolina.  I was there to give a BRIDG update to Working Groups 1 and 2.  The update included a quick BRIDG status, a review of the New Work Item Proposal (NWIP) results  for BRIDG (it passed in August 2009), and the plans for the upcoming ballot through the Joint Initiative Committee (JIC) process.  The group voted to propose  a resolution to the plenary to ballot BRIDG.  So, we’re making progress in our effort to make BRIDG a global, open, publicly available standard.