Architectural review of the BRIDG model (U01)

The Biomedical Research Integrated Domain Group (BRIDG) project is a collaborative effort engaging stakeholders from Clinical Data Interchange Standards Consortium (CDISC), US Food and Drug Administration (FDA), HL7 Regulated Clinical Research Information Management (HL7 RCRIM) Work Group, and US National Cancer Institute (NCI). The goal of BRIDG is to produce a shared view of the domain of protocol-driven research with its associated regulatory artifacts, as well as the basic life sciences research. As the model has evolved over years to meet the needs of multiple stakeholders, CDER is interested in conducting an architectural review of BRIDG, to ensure it is optimized to meet the key objectives of long-term sustainability and interoperability with the healthcare domain.