HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain Group (BRIDG), Release 5

DESCRIPTION

The BRIDG Model is the result of a collaborative effort between CDISC, HL7, ISO, the US FDA, and the US NCI to build a Domain Information Model for Biomedical Research. These groups have participated in the BRIDG development and are working towards the model being approved as an HL7 standard.  The BRIDG model became an ISO standard in 2015 – ISO 14199.  The model and supporting artifacts can be downloaded from https://www.bridgmodel.org or https://bridgmodel.nci.nih.gov

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.   

i.e. 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 postmarket surveillance and adverse event reporting.

The model is being leveraged by vendors, pharmaceutical organizations and some government entities to develop software solutions in clinical research

ALTERNATIVE NAMES

HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain Group (BRIDG), Release 5 may also go by the following names or acronyms:

TARGETS

• Regulatory Agency
• Standards Development Organizations (SDOs)
• US National Cancer Institute (NCI)
• Clinical Trials Management System (CTMS) Vendors, CRO’s, CTMS application developers, etc.
• Pharmaceutical Vendors

BENEFITS

• Produces a shared view of the semantics of a common domain-of-interest, specifically the domain of basic, pre-clinical, clinical, and translational research and its associated regulatory artifacts
• Allows BRIDG stakeholder organizations to realize various data interchange and application interactions that are known to be requirements for semantic interoperability

IMPLEMENTATIONS/CASE STUDIES

• Following are the know implementers of the BRIDG model. Both these entities have implemented parts of the BRIDG model that are relevant to their requirements and are using it in a production environment.

  • PAREXEL and PAREXEL Informatics

  o    PAREXEL and PAREXEL Informatics have utilized BRIDG as the basis for a central canonical data model (CDM) to increase semantic consistency and quality across a diverse portfolio of products and services. BRIDG has provided 1) standard, well-defined terminologies; 2) consistent data types that support the use of those terminologies and that provide metadata for structured data management; and 3) domain models. Together, these benefits create a “shared language” across disparate applications. BRIDG has also been valuable to improve the quality of system integrations and new software development. Historically, PAREXEL Informatics created custom integration solutions for its customers. BRIDG is now being utilized to standardize integration models and semantics to reduce the amount of time required to map customers’ applications, increase the ability to reuse existing code and achieve greater consistency across projects. All new development projects will utilize the BRIDG-based CDM to have a common understanding of how business processes work, a single source of interoperable schemas and code for disparate software implementations and greater consistency across those interoperable systems.

   

  ·         US Food and Drug Administration (JANUS Clinical Trials Repository (CTR) Project)

  o    The Janus CTR is a data warehouse for subject-level clinical trial data submitted to FDA as part of a marketing application. The repository provides FDA review staff easy access to clinical trial data to support regulatory review and to support analyses across studies that address public health and research questions as they emerge. FDA developed the repository jointly with the US National Cancer Institute (NCI).  The CTR conceptual model is informed by the Biomedical Research Integrated Domain Group (BRIDG) Domain Model. For additional information, visit http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm155327.htm

  The development of the BRIDG Model and support for its infrastructure has primarily been provided by the US National Cancer Institute (NCI) and CDISC. The five stakeholders of BRIDG are – CDISC, US FDA, HL7, ISO and the US NCI. 

DEVELOPMENT BACKGROUND

Starting with Release 4.0, the scope of BRIDG model now encompasses translational research, spanning support for not just clinical trials but also imaging, bench research & experiments, and patient-derived data.  These data semantics are represented as a series of UML class diagrams.  The classes are packaged into following subdomains:

·         Adverse Event

·         Biospecimen

·         Common

·         Experiment

·         Imaging

·         Protocol Representation

·         Regulatory

·         Study Conduct

·         Statistical,  and

·         Molecular Biology

There are many other smaller views of the model (Organization, Product, etc.). The BRIDG development team and the WG members are moving towards developing smaller and more consumable set of BRIDG views that focus on core concepts and/or on common clinical research use cases.  The clinical research related concepts in the model are mature and represent the majority of the use cases in clinical research.  Clinical research data exchange standards from CDISC (SDTM, CDASH and TDM) and some HL7 RCRIM work group messages, such as ICSR have been mapped and harmonized with the BRIDG model.

This release of BRIDG model includes semantics from the Imaging domain as they relate to clinical research. This is scoped to support NCI use cases to provide common interoperable semantics between clinical data and the image annotation data collected during the trials.  

RELATED DOCUMENTS

HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain Group (BRIDG), Release 5

(Download) (46.10 MB)

ADDITIONAL DETAILS

The goal of the BRIDG Project is to produce a shared view of the semantics of a common domain-of-interest, specifically the domain of basic, pre-clinical, clinical, and translational research and its associated regulatory artifacts. 

A shared and common semantic view is essential if the clinical research community, both for itself and also as part of the larger Healthcare and life sciences communities, is to achieve semantic interoperability. , i.e. the ability of computer systems to communicate information and have that information properly interpreted by the receiving system in the same sense as intended by the transmitting system. In order to realize the various data interchange and application interactions that are known by members of the BRIDG stakeholder organizations to be requirements for semantic interoperability, a shared view of the semantics must be established. This shared view represented in the BRIDG model as a series of UML class diagrams can be used as:

·         A reference material in development of information system interoperability specifications (Data exchange schemas, APIs, FHIR resources, etc.).

·         A primary artifact from which other information system design specifications are derived. 

o   Logical and Physical models can be built from BRIDG.  These design models are built by constraining the needed BRIDG classes/attributes/associations that are scoped to a particular set of use cases/business scenarios.

·         A common standard representation of the domain to help align and integrate disparate systems and semantics.

·         An early set of detailed meta-data requirements to work with subject matter experts to review, validate and develop additional business requirements. 

·         Leveraging BRIDG early could reduce up-front modeling time and work..

TOPIC

• Regulated Studies

BALLOT TYPE

• Informative

STATUS DATE

2018-10-25

RESPONSIBLE WORK GROUP

PRODUCT TYPE

• Domain Analysis Model

STAKEHOLDERS

• Pharmaceutical Vendors
• Regulatory Agency
• Standards Development Organizations (SDOs)

FAMILY

• V3

CURRENT STATE

• Stable

REALM

• Universal