CDISC Blog  filter by tag: BRIDG,

CDISC SHARE – Progress Report by Rhonda Facile

By now, many of you have heard about the CDISC SHARE project.  For those of you that haven’t,   this new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model. In short we want to change the way we develop standards to an approach that focuses on precise definitions, terminology and metadata (BRIDG, datatypes, variable names, etc.) to take a date element/concept from the clinical protocol, through collection, analysis and submission.  To quote Dave Iberson-Hurst, CDISC is, “moving from the implicit world of data standards to the explicit world of data standards”.

Important BRIDG News and an Update from the ISO Meeting

CDISC co-sponsored and participated in the ISO TC-215 meetings this past week in Rio de Janeiro, Brazil. It was an amazing week with Dr. Christopher Chute assuming the helm of ISO TC-215 Health informatics as Chairperson. It was a productive week for CDISC with positive movement on many fronts. The week began with a CDISC presentation to international delegates from Brazil, Singapore and Australia ...

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 ...

Rebecca Kush, CDISC & the Standards Landscape

The International Standards Organization (ISO) recently held one of its twice-yearly meetings in Durham, North Carolina. Past meetings CDISC attended were in Istanbul, Turkey; Goteborg, Sweden; Edinburgh, Scotland. Here you can see one of the banners at the Durham meetings, thanks to Bron Kisler for the photo...

Rebecca Kush, Bringing the Puzzle Together

November is suddenly upon us and I am wondering where the first 10 months of the year have gone. While welcoming the earlier sunrise (and the end of daylight savings, which brings no favors to those of us who live in the hotter areas nearer the equator), there is reason to reflect on what CDISC has done in the past 10 months of 2009 and where we are going in 2010. There have been many opportunities to do this recently...

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.