Stakeholders

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 since its inception, and has made BRIDG its reference information model for its many standards. Numerous versions of SDTM have been harmonized with BRIDG, the latest being SDTM 3.2, along with previous harmonizations with the CDISC Lab Model, the PGx domains, Trial Design Model and CDASH. On the CDISC side, the CDISC SHARE logical data model is built on a BRIDG-based framework and many of the therapeutic areas were developed with an eye toward BRIDG concepts.

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 and the Clinical Trials Repository in the earlier years, and sponsoring the BRIDG to FHIR mappings more recently.

HL7 Biomedical Research & Regulation (BR&R) Work Group (HL7) – This work 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 was first balloted in ISO in 2010, then again in 2015 (BRIDG 3.2) and it passed the 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 serves as custodians of the BRIDG model managing all modeling and maintenance activities. Semantics from numerous NCI projects have been harmonized with the BRIDG model covering areas such as imaging, oncology, bench research, donor-related clinical trials, etc. NCI hosts the web site and provides modeling, harmonization and curation services for the BRIDG model. NCI also provides other infrastructure support such as GitHub project space, etc. The BRIDG model semantics are also available through NCI’s metadata repository (caDSR).