1. BRIDG Basics

2. 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
A formal model of the shared semantics of regulated clinical trials research
A communication bridge between
clinical trial domain experts and technical experts
different models of clinical trials information
An open community of stakeholders interested in developing standards for exchanging information about clinical trials
HL7 Domain analysis model in Regulated Clinical Research (RCRIM) technical committee
caBIG analysis model for model-driven development
CDISC integrating model for current standards
The semantic foundation for application and message development in HL7, caBIG, and CDISC

3. 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.

4. 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.

5. BRIDG Governance BRIDG Board of Directors
BRIDG Semantic Coordination Committee

6. Current Governance of the BRIDG Model BRIDG Board of Directors
FDA
HL7
CDISC
Academia
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

7. BRIDG Board of Directors
Appointed Members
Charlie Mead
NCI
Bron Kisler
CDISC
Chuck Jaffe
HL7
Jay Levine
FDA
At Large Members
Term Expiration
Becky Kush*
2011
John Speakman
2013
Jack Jones
Cecil Lynch
2012
AbdulMalik Shakir
Diane Wold
Sub Dubman 7
* Chair

8. Current Organization of the BRIDG SCC
CDISC
caBIG
HL7
FDA
BRIDG
Semantic Coordination Committee
Semantic Coordination Committee (SCC)
Responsible for ongoing model maintenance
Harmonizes subdomain projects into the main model
Source: Doug Fridsma

9. Semantic Coordination Committee (SCC)
Name
Affiliation
Charlie Mead
NCI / Booz & Company
Steve Sandberg
NCI / ScenPro, Inc.
Mike Woodcock
NCI / Mayo Clinic
Smita Hastak
Wendy Ver Hoef
Becky Angeles
Julie Evans
CDISC
Lloyd McKenzie
NCI / Gordon Point Informatics 9 9

10. The BRIDG Model

11. Perspectives of BRIDG
Canonical Perspective Domain Analysis Model (DAM), comprehensive UML model with packages for each sub-domain
SME Perspectives Domain friendly business models, separate UML model for each sub-domain
Adverse Event
Common
Protocol Representation
Regulatory
Study Conduct
Ontological Perspective (Future) Model used for semantic validation and inferencing, several OWL-DL representations
HL7 Perspective Formal binding to the HL7 RIM, central DMIM-like diagram with supporting diagrams, modeled in HL7 v3 graphical style

12. 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

13. BRIDG Canonical Perspective
Comprehensive Domain Analysis Model (DAM)
Intended for information analysts
Single UML model
Modeled and managed in Enterprise Architect

14. BRIDG Canonical Perspective Model of Subject

15. BRIDG Comprehensive View – Canonical Perspective
Common
Protocol Representation
Study Conduct
Adverse Event
Regulatory

16. 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

17. BRIDG SME Perspective Adverse Event Sub-Domain Model of Subject

18. 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

19. BRIDG HL7 Perspective Model of Subject

20. BRIDG Semantic Perspective
Several ontological representations
OWL-DL format
Intended for semantic validation and inferencing

21. BRIDG Semantic Perspective Model of Subject

22. 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

23. (starting with most recent release)
BRIDG Content – 1
(starting with most recent release)
Release
Project
Stakeholder
R3.0.3
Clinical Data Acquisition Standards Harmonization (CDASH) V1.1
CDISC
Study Data Tabulation Model (SDTM) V3.1.2
Integrated Case Safety Report (ICSR) R2
FDA
R3.0.2
caBIG® Central Clinical. Participant Registry (C3PR) v2.9
NCI
Cancer Adverse Event Reporting System (caAERS) v2.2
Patient Study Calendar (PSC) v2.6
LabViewer v2.2
R3.0.1
Clinical Trials Registration and Results
HL7 RCRIM
R3.0
(Architecture Redesign only)

24. BRIDG Content - 2 Release Project Stakeholder R2.2
CDISC HL7 Message Study Design (partial)
FDA
CDISC HL7 Message Study Participation
R2.1
Clinical Trial Registry (COPPA, ct.gov, WHO, PRV1.0)
CDISC, NCI
Protocol Abstraction (COPPA – Correlations, Organizations, People and Protocol Abstraction)
NCI
R2.0
Adverse Events
CDISC, NCI, NIH, US Federal Gov’t, FDA
Player / Scoper for Person and Org
NCI, CDISC
Patient Registry (C3PR)
R1.1
Study Data Tabulation Model (SDTM)
CDISC
Trial Design Model
R1.0
Regulated Product Submission (RPS)
FDA/HL7 RCRIM
Patient Study Calendar (PSC)
Clinical Trial Object Model (CTOM)
caXchange/LabHub
NCI/HL7RCRIM TC/CDISC

25. A Bit More About the Canonical and SME Perspectives

26. 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

27. UML Class Diagrams
class – a concept of primary importance the domain-of-interest, depicted as a rectangle labeled with the concept’s 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

28. Class diagram example class attribute data type relationship
multiplicity
data type

29. BRIDG Class: StudyProtocolVersion

30. BRIDG Class Definition: StudyProtocolVersion

31. Definition of designConfigurationCode attribute

32. Instance Diagrams
“Instances” of class diagrams use sample data values to illustrate specific representational constructs

34. Part of an Instance Diagram

35. 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

36. State Transition Diagram – Study Subject

37. 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

38. User’s Guide

39. User’s 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

40. 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 What’s 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 User’s Guide
3.7 BRIDG Domain Analysis Static Model Style Guide
3.8 BRIDG CDISC Comment Resolution Spreadsheet
4 Known Issues

41. UML-based Model: Mappings to Source Projects Enterprise Architect

42. UML-Based Model Mappings to Source Projects RTF Report
methodCode
public :CD
A coded value specifying the technique that is used to perform the procedure.For example, for a specimen collection, finger stick, veni puncture, Abdominal/ ascites effusion, Biopsy, Bronchial alveolar lavage (BAL), etc.For example, if procedure is cholecystectomy the method could be open or laparoscopic.
Map:CTOM = 'SpecimenAcquisition.methodCode'
Map:Lab = 'SpecimenCollection.method'
Map:SDTM IG = 'EG.EGMETHOD'
Map:SDTM IG = 'LB.LBMETHOD'

43. Foundation of rigorously defined data types
Simple vs Abstract
Simple: Character, String, Text, Numeric
BRIDG uses ISO data type specification

44. 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

45. Interfacing with Controlled Vocabularies
Plans to move BRIDG semantics into a controlled environment such as NCI’s EVS / caDSR
BRIDG controlled vocabulary should integrate with existing stakeholder vocabulary

46. Project Team involves BRIDG SCC early
What’s 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

47. A Look at the Model in Enterprise Architect
How to get to the version for review:
How to get to the model on the internet
The gForge site:
Release Files
News
Bug and enhancement trackers
Work in progress in Subversion

49. 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

50. Enterprise Architect – Project Browser

51. Project Browser - Views

52. Protocol Representation View

53. Comprehensive View

54. Project Browser – State Transition Diagrams

56. Project Browser – Instance Diagrams