Background

The Biomedical Research Integrated Domain Group (BRIDG) Model is a collaborative effort engaging stakeholders from the Clinical Data Interchange Standards Consortium (CDISC), the HL7 BRIDG Work Group, the International Organization for Standardization (ISO), the US National Cancer Institute (NCI), and the US Food and Drug Administration (FDA). The goal of the BRIDG Model is to produce a shared view of the dynamic and static semantics for the domain of basic, pre-clinical, clinical, and translational research and its associated regulatory artifacts. This domain of interest is further defined as:


The data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, biologic, cosmetic, food or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with post-market surveillance and adverse event reporting.

Brief Overview

  • BRIDG model is supported by the HL7 BR&R WG as its domain information model and intended to provide the semantic foundation to the artifacts developed by this WG. It is a conceptual model, although parts of the model are quite granular and therefore often considered a hybrid of conceptual and logical layers.
  • BRIDG is a platform-independent model and can be implemented in many different ways. It can be leveraged as a domain information model to develop detailed design artifacts, such as - database designs, APIs, data exchange formats, etc.
  • The model is represented as a UML class diagram and managed and maintained in Sparx Systems- Enterprise Architect Tool. 
  • It is periodically balloted through three Standards Development Organization (SDOs) - HL7, CDISC and ISO. (ISO 14199)


To learn more about the BRIDG Model, visit https://bridgmodel.nci.nih.gov/

Scope

PSS Link:   PSS


Project Status

  • ACTIVE  (Status Date: 2022)

BRIDG 5.3 was balloted in May 2019

Q1 2023 – BRIDG 5.3 is going thru ISO balloting

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