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BRIDG R3.0.1 CDISC ISO JIC Review and Comment Period

Foreword

The BRIDG Model is a Domain Analysis Model (DAM) for biomedical research. More specifically, it is an open shared view of the dynamic and static semantics of a common domain-of-interest, focused on the domain of protocol-driven research and its associated regulatory artifacts. The BRIDG model was initiated through the Clinical Data Interchange Standards Consortium (CDISC), a global standards development organization, to ensure that the standards developed in the clinical research domain would be harmonized with each other and that they would appropriately harmonize with the HL7 Reference Information Model (RIM) to support a link between medical research and healthcare.  Shortly after it’s initiation by CDISC, the US National Cancer Institute (NCI), Health Level 7’s (HL7) Regulated Clinical Research Information Management Technical Committee (RCRIM) Work Group and the US Food and Drug Administration (FDA) joined the effort to build this model.  In early 2010, the BRIDG model became a standard through the CDISC Standards Development Process. The BRIDG model is currently at Release 3.0.1, which is being balloted through the ISO Joint Initiative Council (JIC) process.


The following pdf document is being balloted through reference to the BRIDG model at www.cdisc.org/bridg, which is a dynamic model.  The Clinical Data Interchange Standards Consortium (CDISC) is the lead organization for taking this standard through the ballot process.

 

Full Details here (please read before completing the comment sheet)

Comments due by 7 May 2010.  Download the comment spreadsheet here