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BRIDG Basics 1. What is BRIDG? Biomedical Research Integrated Domain Group A formal model A communication bridge An open community of stakeholders The.

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Presentation on theme: "BRIDG Basics 1. What is BRIDG? Biomedical Research Integrated Domain Group A formal model A communication bridge An open community of stakeholders The."— Presentation transcript:

1 BRIDG Basics 1

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 2

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. 3

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. 4

5 BRIDG Governance 5 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 6 BRIDG Board of Directors NCI Academia Pharma Industry CDISC HL7FDA Source: Doug Fridsma

7 7 BRIDG Board of Directors 7 Appointed Members Charlie MeadNCI Bron KislerCDISC Chuck JaffeHL7 Jay LevineFDA At Large MembersTerm Expiration Becky Kush*2011 John Speakman2013 Jack Jones2011 Cecil Lynch2012 AbdulMalik Shakir2012 Diane Wold2013 Sub Dubman2013 * Chair

8 Current Organization of the BRIDG SCC Semantic Coordination Committee (SCC) – Responsible for ongoing model maintenance – Harmonizes subdomain projects into the main model 8 BRIDG Semantic Coordination Committee caBIGHL7CDISCFDA Source: Doug Fridsma

9 9 9 Semantic Coordination Committee (SCC) NameAffiliation Charlie MeadNCI / Booz & Company Steve SandbergNCI / ScenPro, Inc. Mike WoodcockNCI / Mayo Clinic Smita HastakNCI / ScenPro, Inc. Wendy Ver HoefNCI / ScenPro, Inc. Becky AngelesNCI / ScenPro, Inc. Julie EvansCDISC Lloyd McKenzieNCI / Gordon Point Informatics

10 The BRIDG Model 10

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

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 12

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

14 BRIDG Canonical Perspective Model of Subject 14

15 15 BRIDG Comprehensive View – Canonical Perspective Protocol Representation Adverse Event Study Conduct Common 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 16

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

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 18

19 BRIDG HL7 Perspective Model of Subject 19

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

21 BRIDG Semantic Perspective Model of Subject 21

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 22

23 23 BRIDG Content – 1 (starting with most recent release) ReleaseProjectStakeholder R3.0.3Clinical Data Acquisition Standards Harmonization (CDASH) V1.1 CDISC Study Data Tabulation Model (SDTM) V3.1.2CDISC Integrated Case Safety Report (ICSR) R2FDA R3.0.2caBIG ® Central Clinical. Participant Registry (C3PR) v2.9NCI Cancer Adverse Event Reporting System (caAERS) v2.2NCI Patient Study Calendar (PSC) v2.6NCI LabViewer v2.2NCI R3.0.1Clinical Trials Registration and ResultsHL7 RCRIM R3.0(Architecture Redesign only)

24 24 ReleaseProjectStakeholder R2.2CDISC HL7 Message Study Design (partial)FDA CDISC HL7 Message Study ParticipationFDA R2.1Clinical Trial Registry (COPPA,, WHO, PRV1.0)CDISC, NCI Protocol Abstraction (COPPA – Correlations, Organizations, People and Protocol Abstraction) NCI R2.0Adverse EventsCDISC, NCI, NIH, US Federal Govt, FDA Player / Scoper for Person and OrgNCI, CDISC Patient Registry (C3PR)NCI R1.1Study Data Tabulation Model (SDTM)CDISC Trial Design ModelCDISC R1.0Regulated Product Submission (RPS)FDA/HL7 RCRIM Patient Study Calendar (PSC)NCI Clinical Trial Object Model (CTOM)NCI caXchange/LabHubNCI/HL7RCRIM TC/CDISC BRIDG Content - 2

25 A Bit More About the Canonical and SME Perspectives 25

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 26

27 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 27

28 28 Class diagram example class attribute relationship multiplicity data type

29 BRIDG Class: StudyProtocolVersion 29

30 BRIDG Class Definition: StudyProtocolVersion 30

31 Definition of designConfigurationCode attribute 31

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

33 33

34 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 35

36 State Transition Diagram – Study Subject 36

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 37

38 Users Guide 38

39 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 Users Guide 39

40 Release Notes 40 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

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

42 UML-Based Model Mappings to Source Projects RTF Report 42 methodCodepublic :CDA 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 21090 data type specification 43

44 Datatypes: Complex 44 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 NCIs EVS / caDSR BRIDG controlled vocabulary should integrate with existing stakeholder vocabulary 45

46 Whats the Process? 46 Project Team develops Domain Analysis Model, mapping spreadsheet, valid value lists Project Team involves BRIDG SCC early Updated BRIDG Domain Analysis Model is created Reps from project team meet with SCC to harmonize the project model into the BRIDG 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: php/id/1938 How to get to the model on the internet – – The gForge site: Release Files News Bug and enhancement trackers Work in progress in Subversion 47

48 48

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 49

50 Enterprise Architect – Project Browser 50 Project Browser

51 Project Browser - Views 51

52 52 Protocol Representation View

53 53 Comprehensive View

54 Project Browser – State Transition Diagrams 54

55 55

56 Project Browser – Instance Diagrams 56

57 57

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