BRIDG Basics

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BRIDG Basics
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What is BRIDG?Biomedical Research Integrated
Domain Group

• A formal model
• A communication bridge
• An open community of stakeholders
• The semantic foundation for application and
  message development

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How did BRIDG get started?

• Four important streams of development came
  together
• CDISC In early 2004, CDISC started constructing
  a Domain Analysis Model to support harmonization
  of their standards for clinical research as well
  as with the Health Level Seven (HL7) healthcare
  standard.
• NCI In late 2004, NCI's Cancer Biomedical
  Informatics Grid (caBIG) initiative joined the
  CDISC BRIDG efforts to construct a structured
  protocol representation for its Clinical Trials
  Management Systems (CTMS) Workspace, in order to
  further interoperability among clinical trials
  research in cancer.
• HL7 In 2005, the BRIDG model was adopted by the
  HL7 Regulated Clinical Research Information
  Management (RCRIM) Technical Committee as the
  RCRIM Domain Analysis Model.
• FDA In 2007, the US Food and Drug Administration
  included BRIDG in their 5 year IT Plan as a
  foundation for several projects.

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BRIDG Scope

• BRIDG Scope Protocol-driven 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 post-marketing
  adverse event reporting.

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BRIDG Governance

• BRIDG Board of Directors
• BRIDG Semantic Coordination Committee

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Current Governance of the BRIDG Model BRIDG Board
of Directors
HL7
FDA
Academia
CDISC
NCI
Pharma Industry
BRIDG Board of Directors

• BRIDG Board of Directors
• Representation from the current stakeholders
• Helps to set priorities and identify resources

Source Doug Fridsma
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BRIDG Board of Directors
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Chair
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Current Organization of the BRIDG SCC
caBIG
HL7
CDISC
FDA
BRIDG Semantic Coordination Committee

• Semantic Coordination Committee (SCC)
• Responsible for ongoing model maintenance
• Harmonizes subdomain projects into the main model

Source Doug Fridsma
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Semantic Coordination Committee (SCC)
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The BRIDG Model
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Perspectives of BRIDG
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Perspectives of BRIDG

• Recognize and support the different types of
  BRIDG users
• Each perspective is intended for a different
  audience
• Each perspective is a representation of the same
  semantics

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BRIDG Canonical Perspective

• Comprehensive Domain Analysis Model (DAM)
• Intended for information analysts
• Single UML model
• Modeled and managed in Enterprise Architect

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BRIDG Canonical PerspectiveModel of Subject
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BRIDG Comprehensive View Canonical Perspective
Common
Protocol Representation
Study Conduct
Adverse Event
Regulatory
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BRIDG SME Perspective

• Domain-friendly layer
• Intended for the subject matter experts (also
  called business users or domain experts)
• Multiple UML models, one for each sub-domain
• Modeled and managed in Enterprise Architect
• Automatically generated from Canonical Perspective

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BRIDG SME PerspectiveAdverse Event Sub-Domain
Model of Subject
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BRIDG HL7 Perspective

• RIM-based model
• Intended for message developers
• Modeled in HL7 proprietary modeling methodology
  and developed in Visio
• Single DMIM-like model
• Maps to UML-based model
• Manually generated from Canonical Perspective

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BRIDG HL7 PerspectiveModel of Subject
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BRIDG Semantic Perspective

• Several ontological representations
• OWL-DL format
• Intended for semantic validation and inferencing

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BRIDG Semantic PerspectiveModel of Subject
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BRIDG as a global, public standard

• CDISC Review and Comment Process resulted in
  BRIDG as a CDISC standard in January 2010
• ISO Joint Initiative Council (JIC) Ballot Process
  first round in May 2010 BRIDG passed the
  ballot in both ISO and HL7 next round starts in
  December 2010
• ISO
• HL7
• CDISC

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BRIDG Content 1 (starting with most recent
release)
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BRIDG Content - 2
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A Bit More About the Canonical and SME
Perspectives
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Unified Modeling Language

• Used in the BRIDG model via a modeling tool
  called Enterprise Architect
• The industry-standard language for specifying,
  visualizing, constructing, and documenting the
  requirements of software systems
• The BRIDG model uses these UML diagrams
• Class diagrams
• Instance diagrams
• State transition diagrams

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UML Class Diagrams

• class a concept of primary importance the
  domain-of-interest, depicted as a rectangle
  labeled with the concepts name
• attribute (including datatype specification) a
  descriptive feature of a class, depicted as being
  contained within the class
• relationship one of several types of lines
  between classes

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Class diagram example
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BRIDG Class StudyProtocolVersion
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BRIDG Class Definition StudyProtocolVersion
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Definition of designConfigurationCode attribute
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Instance Diagrams

• Instances of class diagrams use sample data
  values to illustrate specific representational
  constructs

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Part of an Instance Diagram
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State Transition Diagrams

• A State Transition Diagram illustrates how an
  element (often a Class) can move between states,
  classifying its behavior according to transition
  triggers and constraining guards.
• Also called State Machine Diagrams or State
  Charts

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State Transition Diagram Study Subject
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Important Components of a Release

• The Model
• UML Based Model in Enterprise Architect Model
• Sub-Domains and Comprehensive View
• RIM Based Model
• Users Guide and Release Notes
• Change Lists
• Mapping Spreadsheet

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Users Guide
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Users Guide

• Section 1 Guide to the Reader
• Section 2 Executive Summary
• Section 3 The BRIDG Project and BRIDG Model
• Section 4 The BRIDG Model General
  Considerations and Representational Conventions
• Section 5 Model Content
• Section 6 Glossary
• Section 7 Appendix

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Release Notes

• Table of Contents
• 1 Executive Summary
• 1.1 BRIDG ISO Joint Initiative Council (JIC)
  Ballot
• 1.2 BRIDG Definition
• 1.3 BRIDG Project Stakeholders
• 1.4 BRIDG Project Goals
• 1.5 Definition of BRIDG Model Domain of Interest
• 2 Whats New in Release 3.0.1
• 2.1 General changes in Release 3.0.1
• 2.2 Detailed Change Lists for Release 3.0.1
• 3 Files in R3.0.1 Package
• 3.1 UML-Based Models
• 3.2 RIM-based Models
• 3.3 Report of Comprehensive UML-Based Model
• 3.4 XMI of Comprehensive UML-Based Model
• 3.5 Release Notes (this file)
• 3.6 Users Guide
• 3.7 BRIDG Domain Analysis Static Model Style
  Guide
• 3.8 BRIDG CDISC Comment Resolution Spreadsheet

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UML-based Model Mappings to Source Projects
Enterprise Architect
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UML-Based ModelMappings to Source Projects RTF
Report
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Foundation of rigorously defined data types

• Simple vs Abstract
• Simple Character, String, Text, Numeric
• BRIDG uses ISO 21090 data type specification

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Datatypes Complex
ISO 21090 Healthcare Data Types
ST String CD Concept Descriptor (Coded
Concept) DSET unordered collection, unique
values ED Encapsulated data URG Uncertain
Range RTO Ratio II Instance Identifier

• Some CD properties
• displayName
• originalText
• code
• codeSystemName
• codeSystemVersion
• valueSet
• And more

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Interfacing with Controlled Vocabularies

• Plans to move BRIDG semantics into a controlled
  environment such as NCIs EVS / caDSR
• BRIDG controlled vocabulary should integrate with
  existing stakeholder vocabulary

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Whats the Process?
Project Team develops Domain Analysis Model,
mapping spreadsheet, valid value lists Project
Team involves BRIDG SCC early
Reps from project team meet with SCC to harmonize
the project model into the BRIDG
Updated BRIDG Domain Analysis Model is created
The project to BRIDG mapping spreadsheet needs to
be maintained
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A Look at the Model in Enterprise Architect

• How to get to the version for review
• http//www.cdisc.org/contentmgr/showdetails.php/id
  /1938
• How to get to the model on the internet
• www.bridgmodel.org
• The gForge site
• Release Files
• News
• Bug and enhancement trackers
• Work in progress in Subversion

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www.bridgmodel.org
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A Look at the Model in Enterprise Architect

• How to open the model and look at basic
  components
• Project Browser
• Views
• Class diagrams
• State Transition Diagrams
• Instance diagrams

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Enterprise Architect Project Browser
Project Browser
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Project Browser - Views
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Protocol Representation View
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Comprehensive View
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Project Browser State Transition Diagrams
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Project Browser Instance Diagrams
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