BRIDG and the Clinical Data Interchange Standards Consortium (CDISC)

In 2003, CDISC initiated the domain analysis model that eventually became known as BRIDG. CDISC has been involved in BRIDG ever since, 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 3.1.32 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. The mappings from all the CDISC harmonizations with the BRIDG model provide a visual representation of CDISC standards, and help ensure different software systems and databases developed using the model share semantics to meaningfully exchange data. For many years, CDISC participated on the modeling team and also balloted BRIDG through it’s comment process. CDISC continues to be involved in BRIDG by being represented on the steering committee and promoting the BRIDG standard on their website

CDISC Standards Mapped to BRIDG

For each harmonization of a CDISC standard with BRIDG there is a worksheet in the BRIDG Mapping Spreadsheet containing the details. Mapping tags for each of those CDISC elements are defined on the corresponding BRIDG model elements in the model itself. Several corresponding subset diagrams are available in the CDISC Views package also in the model. CDISC standards harmonized with BRIDG include:

  • SDTM IG v3.2 was mapped to BRIDG and published in BRIDG 5.3; also mapped are PGx domains r1.0, and SDTM IG v3.1.3, v3.1.2, and v3.1.1
  • CDISC Lab Model v1.0.1
  • Statistics v1.0
  • CDASH v1.1
  • Trial Design Model