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BRIDG Basics

BRIDG Basics. What is BRIDG? B iomedical R esearch I ntegrated D omain G roup. A formal model A communication bridge An open community of stakeholders The semantic foundation for application and message development. How did BRIDG get started?.

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BRIDG Basics

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  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

  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 • BRIDG Board of Directors • Representation from the current stakeholders • Helps to set priorities and identify resources FDA HL7 CDISC Academia NCI Pharma Industry BRIDG Board of Directors Source: Doug Fridsma

  7. BRIDG Board of Directors 7 * Chair

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

  9. Semantic Coordination Committee (SCC) 9

  10. The BRIDG Model

  11. Perspectives of BRIDG

  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 PerspectiveModel 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 PerspectiveAdverse 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 PerspectiveModel of Subject

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

  21. BRIDG Semantic PerspectiveModel 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. BRIDG Content – 1 (starting with most recent release)

  24. BRIDG Content - 2

  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

  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

  33. Part of an Instance Diagram

  34. 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

  35. State Transition Diagram – Study Subject

  36. 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

  37. User’s Guide

  38. 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

  39. Release Notes Table of Contents 1Executive Summary 1.1BRIDG ISO Joint Initiative Council (JIC) Ballot 1.2BRIDG Definition 1.3BRIDG Project Stakeholders 1.4BRIDG Project Goals 1.5Definition of BRIDG Model Domain of Interest 2What’s New in Release 3.0.1 2.1General changes in Release 3.0.1 2.2Detailed Change Lists for Release 3.0.1 3Files in R3.0.1 Package 3.1UML-Based Models 3.2RIM-based Models 3.3Report of Comprehensive UML-Based Model 3.4XMI of Comprehensive UML-Based Model 3.5Release Notes (this file) 3.6User’s Guide 3.7BRIDG Domain Analysis Static Model Style Guide 3.8BRIDG CDISC Comment Resolution Spreadsheet 4Known Issues

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

  41. UML-Based ModelMappings to Source Projects RTF Report

  42. Foundation of rigorously defined data types • Simple vs Abstract • Simple: Character, String, Text, Numeric • BRIDG uses ISO 21090 data type specification

  43. 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

  44. 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

  45. 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

  46. 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

  47. www.bridgmodel.org

  48. 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

  49. Enterprise Architect – Project Browser Project Browser

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