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BRIDG Model

BRIDG Release 3.2 Now Available

 

The Clinical Data Interchange Standards Consortium (CDISC), Health Level Seven (HL7), the U.S. Food and Drug Administration (FDA) and the U.S. National Cancer Institute (NCI) are pleased to announce the release of version 3.2 of the Biomedical Research Integrated Domain Group (BRIDG) model of the semantics of protocol-driven clinical research. Release 3.2 of the model is available for download at: http://bridgmodel.nci.nih.gov/download_model.

 

For a description of the changes in the BRIDG R3.2, please follow the link.  

 

 

Call for Subject Matter Experts

The Need:  The BRIDG Semantic Coordination Committee (SCC) works under the guidance of the BRIDG Board of Directors (BoD) to bring new semantics into the BRIDG Model by working with project teams to harmonize their models into BRIDG.  Project teams often bring subject matter experts into this process to help clarify the domain view of the concepts.  However, sometimes project-level subject matter experts are unavailable, or an issue comes up after the project is complete and the team has disbanded, or a BRIDG user submits a feature request that needs vetting by the community.  This often leaves the SCC with no subject matter experts with whom to discuss domain semantics.


The Solution:  To meet this need, the BRIDG SCC is starting an informal group of domain experts with various areas of expertise to whom we could direct questions on an as-needed basis.  The areas of expertise that we seek include, but are not limited to, the following:

  • Clinicians,
  • Biostatisticians,
  • Clinical Research Associates (CRAs),
  • Research Nurses,
  • Data Managers,
  • Protocol Writers,
  • Protocol Coordinators,
  • Regulatory Compliance Officers, and
  • FDA Reviewers.   

We will only contact members of this group who have the expertise related to the subject in question and the members don’t need experience in modeling.  We will usually limit the interaction to email, with occasional conference calls if warranted by the complexity of the problem or the diversity of opinions expressed in email.  We may occasionally ask the experts to reach into their network of colleagues to find answers or build consensus. .  The time commitment is not expected to exceed 5 hours per month, often less, and would be on a volunteer basis.  We ask for a 1 or 2 year commitment and will rotate membership in the group to prevent burn-out, to spread the opportunity to participate among many individuals, and to ensure that we have “fresh eyes” coming into the group on a regular basis.


Your Part:  If you are interested in participating in this group, please send an email to bridgTHC-L@list.nih.gov with the following information:

  • Name,
  • E-mail,
  • Phone Number,
  • Area(s) of Expertise,
  • Affiliation (i.e. name of agency, hospital, pharma company, etc.).

Participation in this group will give you the opportunity to influence the BRIDG model and the satisfaction of knowing your area of expertise will be accurately represented.

 

Background

The Biomedical Research Integrated Domain Group (BRIDG) Model is a domain analysis model representing protocol-driven biomedical/clinical research. It was developed to provide an overarching model that could readily be understood by domain experts and would provide the basis for harmonization among standards within the clinical research domain and between biomedical/clinical research and healthcare.

Three important streams of development have been brought together into this collaborative framework:

 

  • CDISC – In 2003, CDISC started constructing a Domain Analysis Model to support harmonization of their models as well as with HL7.
  • NCI – In 2004, the NCI's caBIG initiative joined the CDISC BRIDG efforts to construct a structured protocol representation and to achieve interoperability among clinical trials research in cancer
  • In early 2005, the BRIDG model was been adopted by the HL7 RCRIM Technical Committee as the RCRIM Domain Analysis Model and is being implemented at NCI.

The model emerged from an unprecedented collaborative effort among clinical trial experts from CDISC, the US National Institutes of Health (NIH)/National Cancer Institute (NCI), the Food and Drug Administration (FDA), Health Level Seven (HL7), and other volunteers. The modeling effort is using the HL7 Development Framework (HDF).

This structured information model is being used to support development of data interchange standards and technology solutions that will enable harmonization between the biomedical/clinical research and healthcare arenas.

The BRIDG Model serves to bridge standards, as well as organizations and various communities, including academic research institutions and pharmaceutical product development organizations and related service and technology providers. It is also bridging the gap between clinical research and healthcare.