Health informatics – Information models – Biomedical Research Integrated Domain Group (BRIDG) Model

This document defines a set of models collectively referred to as the Biomedical Research Integrated Domain Group (BRIDG) model. This model supports the development of computer software, databases, metadata repositories and data interchange standards by enabling semantic interoperability within the biomedical and clinical research domain and between the research and healthcare domains. Clinical research semantics are represented as a set of visual diagrams that describe the information relationships, definitions, explanations and examples used in protocol-driven biomedical research.

This standard establishes the links between protocol-driven research and its associated regulatory artefacts, including the data, organisation, resources, rules, and processes involved in the formal assessment of a drug, procedure, process, subject characteristic, or device. This includes data associated with postmarketing adverse event reporting.

Main sections:

· Scope

· Normative references

· Terms and definitions

· Overview of conceptual representations of the BRIDG model

· UML-based canonical representations

· RIM-based HL7 representation

· Ontological OWL-based representation

· Other additional information