ISO 14199:2024
(Main)Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model
Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model
This document is complementary to the Biomedical Research Integrated Domain Group (BRIDG) model. It is a high-level overview of BRIDG in general and BRIDG version 5.3.1 in specific. This document also provides necessary links to artifacts that detail the changes between BRIDG v3.2 and BRIDG v5.3.1[5] and to the BRIDG Release Download page.
Informatique de santé — Modèle d'information — Modèle de groupe de domaine intégré de recherche biomédicale (BRIDG)
General Information
Relations
Standards Content (Sample)
International
Standard
ISO 14199
Second edition
Health informatics — Information
2024-12
models — Biomedical Research
Integrated Domain Group
(BRIDG) Model
Informatique de santé — Modèle d'information — Modèle de
groupe de domaine intégré de recherche biomédicale (BRIDG)
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 Overview of conceptual representations of the BRIDG model . 2
6 UML-based canonical representations . 3
6.1 General considerations.3
6.2 Subdomain UML views .3
6.2.1 Adverse Event .3
6.2.2 Biospecimen .3
6.2.3 Common .3
6.2.4 Experiment .3
6.2.5 Imaging .3
6.2.6 Molecular Biology (out-of-scope for balloting) .4
6.2.7 Protocol Representation . .4
6.2.8 Regulatory – Change in Deprecation Plans .4
6.2.9 Statistical Analysis .4
6.2.10 Study Conduct .4
6.3 UML-based models and views .5
7 RIM-based HL7 representation (version 3.2 only). 5
7.1 General considerations.5
7.2 RIM-based models .5
8 Ontological OWL-based representation (version 3.2 only) . 6
9 Additional information . 6
9.1 Uses of BRIDG .6
9.2 User’s guide for the BRIDG model .6
9.3 BRIDG v3.2 to v.5.3.1 change list .7
Bibliography . 8
iii
Foreword
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The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
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This document was prepared by Technical Committee ISO/TC 215 Health informatics.
This second edition cancels and replaces the first edition (ISO 14199:2015), which has been technically
revised.
The main changes are as follows:
— in the Introduction a description was added about the difference between this document and the BRIDG
model, which is predominantly represented as a large UML Model, not captured in this document;
— the main differences between BRIDG version 3.2 and BRIDG version 5.3.1 have been identified;
— a sentence was added in 9.1 indicating that all artefacts of the BRIDG model are downloadable from the
BRIDG website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
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 US National Cancer Institute (NCI), the US Food and Drug Administration (FDA), and the International
Organization for Standardization’s (ISO) Technical Committee on health informatics, TC 215. The BRIDG
model was developed to closely integrate medical research information with healthcare, as well as integrate
information within medical research. Clinical research data processes use a variety of meanings, formats,
and data types that inhibit the ability and potential to share, integrate, and disseminate clinical research
data, thus slowing and, in many cases, ending promising drug discovery and development processes. Vast
bodies of medical knowledge data either do not exist in an electronic format that is useful for today's dynamic
decision support systems or are electronic but are locked into discrete proprietary systems. Once freed,
information that is locked away in static documents and discrete databases can flow through the processes
of medical research. In an ideal world, critical data can be accessed, read, and aggregated by any tool at any
point in the process. The tools would become the effective means of communication crossing all the existing
boundaries and would enable automation of many procedures that currently take place manually. Removing
the time-consuming procedure of translating and transcribing data contained in dissimilar and proprietary
information stores would allow scientists to focus on science and innovation. For this to become reality,
medical research data must be machine-readable and semantically interoperable.
The BRIDG model provides an approach to remove semantic ambiguities present in medical research. The
BRIDG is intended to represent a shared view of the semantics of the domain of protocol-driven research
and its associated regulatory artefacts. The need for BRIDG became clear when various source projects
contributed semantic content which was not interoperable. These source projects are documented in the
model using tags in each class and attribute as well as other associations. These tags indicate the source
project elements from which the concept was derived or to which the element maps.
Information about the projects contributing to the BRIDG content can be found in the BRIDG user's guide in
[2]
the section entitled “Projects Contributing to the BRIDG Model” and in the BRIDG mapping spreadsheet
[2]
and the Download Release Packages & Browse Online page on the BRIDG website for a table listing the
[2]
projects that were harmonized in each version throughout BRIDG’s history. The background page under
the About tab includes an overview of the history of the BRIDG model noting contributing projects.
Since BRIDG v3.2, there have been a few versions and many model changes. The current version, BRIDG v5.3.1,
is now a complex, 300+ class model with hundreds of attributes and relationship, definitions and examples,
etc., all captured in a Unified Modelling Language (UML) tool called Enterprise Architect. It is also available
in an XMI format export, and is accompanied by a User's Guide, a mapping spreadsheet detailing use cases
for all the semantics and a change list identifying all the changes from v3.2 to v5.3.1.
The key differences between the 2015 version of BRIDG (v3.2) and the latest version of BRIDG (v5.3.1) can
be summarized as follows:
— harmonization of models, projects and standards with the BRIDG model;
— new semantics added as a result of model harmonization include a range of topics in the areas of
life science, SDTM 3.1.3, 3.2 and Pharmacogenomic, Pharmacogenetics domains, clinical research
organization administration, and imaging and annotation;
— artefacts updated include pertinent files from the release package for BRIDG 5.3.1 and a report detailing
the differences between BRIDG 3.2 and BRIDG 5.3.1.
v
International Standard ISO 14199:2024(en)
Health informatics — Information models — Biomedical
Research Integrated Domain Group (BRIDG) Model
1 Scope
This document is complementary to the Biomedical Research Integrated Domain Group (BRIDG) model. It is
a high-level overview of BRIDG in general and BRIDG version 5.3.1 in specific. This document also provides
[5]
necessary
...
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