BRIDG model: representing the shared semantics in protocol-driven research

Wednesday, October 26, 2011 — Poster Session III
10:00 a.m. – Noon	Natcher Conference Center	NCI	CLIN/CULT/AGING/DISPREV-8

Authors

• S Hastak
• S Sandberg
• W Ver Hoef
• J Evans
• R Angeles
• L McKenzie
• M Woodcock
• C Mead
• E Helton
• J Speakman

Abstract

The BRIDG (Biomedical Research Integrated Domain Group) model is domain analysis model representing the domain of biomedical/clinical protocol-driven research. It has been developed to be understood by the subject matter experts and to harmonize the various standards efforts in clinical research. The BRIDG model is an overarching model of the domain and serves as the foundation for a common understanding and representation of the concepts in clinical trials research. It is being leveraged to develop data exchange standards and enable data sharing and meaning-based semantic interoperability across the larger clinical research community. The semantics of protocol representation, clinical trials registries, adverse events, participant registration are some examples of the kinds of protocol related concepts that are represented in the BRIDG model. The domain concepts and their relationships are represented as a UML class diagram. The BRIDG model is a collaborative effort of stakeholders from the Clinical Data Interchange Standards Consortium (CDISC), the HL7 Regulated Clinical Research Information Management Technical Committee (RCRIM TC), the National Cancer Institute (NCI), and the US Food and Drug Administration (FDA) and is currently being balloted through the ISO JIC standardization process.

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