Stakeholders

last modified:
01/30/2017 - 21:46

The BRIDG Project is a collaborative effort engaging stakeholders from five organizations:

  • Clinical Data Interchange Standards Consortium (CDISC) - CDISC initiated BRIDG and has been involved in BRIDG since its inception and has made BRIDG its reference information model for its many standards. The CDISC SHARE logical data model is built upon a framework based on the BRIDG Model and ISO 21090 data types. Numerous versions of SDTM have been harmonized with BRIDG, the latest being SDTM 3.1.3 along with the PGx domains. Many of the therapeutic areas developed over the last few years have had an eye toward BRIDG concepts, evident in the concept maps associated with many therapeutic area IGs.
  • US Food and Drug Administration (FDA) - The FDA has been an active participant in BRIDG, assisting in the harmonization of the adverse event model, the HL7 ICSR, Study Design and Study Participation messages in the earlier years and the Clinical Trials Repository more recently. Currently FDA is helping to drive discussions about architecture for a sustainable model going into the future.
  • HL7 BRIDG, RCRIM and Biomedical Research & Regulation (BR&R) Work Groups (HL7) - The HL7 BRIDG WG was started in 2014 by Dr. Ed Helton (NCI) and Mary Ann Slack (FDA) to exclusively focus on the BRIDG model. Before 2014, the BRIDG model project was part of the HL7 RCRIM work group. The two HL7 work groups (BRIDG and RCRIM) have now decided to re-merge into a single new work group called Biomedical Research and Regulation (BR&R). This new group’s areas of interest encompass clinical and translational research, both regulated and non-regulated, and the subsequent regulatory submissions and information exchanges to bring new products to market and to ensure safe use throughout the product lifecycle. BR&R creates and promotes standards to facilitate biomedical research and any subsequent regulatory evaluation of the safety, efficacy and quality of medical products that may arise from research.
  • International Organization for Standardization (ISO) – BRIDG 3.0.1 was first balloted in ISO in 2010, and given the identifier ISO 14199. Comments were address during the ISO meeting in Brazil in May of 2010 and resolutions published in the next release of BRIDG 3.0.3 in Dec. 2010. BRIDG was balloted in ISO again, this time release BRIDG 3.2, in 2015 and passed ISO balloting process. BRIDG is now an ISO standard, ISO 14199. ISO has been added as the fifth stakeholder in BRIDG and is now represented on the BRIDG Steering Committee.
  • US National Cancer Institute (NCI) - The NCI has sponsored much of the development of the BRIDG model and contributed semantics from numerous projects, with the new Imaging sub-domain’s DICOM and Annotation and Image Markup (AIM) concepts along with the Surveillance, Epidemiology & End Results (SEER) concepts being the most recent. Other projects started include harmonizing additional radiology and pathology imaging concepts with BRIDG. NCI hosts the web site and provides modeling, harmonization and curation services for the BRIDG model. NCI also provides other infrastructure support such as SVN, Jira, etc.