2 What is BRIDG? Biomedical Research Integrated Domain Group A formal modelA communication bridgeAn open community of stakeholdersThe semantic foundation for application and message developmentA formal model of the shared semantics of regulated clinical trials researchA communication bridge betweenclinical trial domain experts and technical expertsdifferent models of clinical trials informationAn open community of stakeholders interested in developing standards for exchanging information about clinical trialsHL7 Domain analysis model in Regulated Clinical Research (RCRIM) technical committeecaBIG analysis model for model-driven developmentCDISC integrating model for current standardsThe semantic foundation for application and message development in HL7, caBIG, and CDISC
3 How did BRIDG get started? Four important streams of development came togetherCDISC: 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 ScopeBRIDG 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.
6 Current Governance of the BRIDG Model BRIDG Board of Directors FDAHL7CDISCAcademiaNCIPharma IndustryBRIDGBoard of DirectorsBRIDG Board of DirectorsRepresentation from the current stakeholdersHelps to set priorities and identify resourcesSource: Doug Fridsma
7 BRIDG Board of Directors Appointed MembersCharlie MeadNCIBron KislerCDISCChuck JaffeHL7Jay LevineFDAAt Large MembersTerm ExpirationBecky Kush*2011John Speakman2013Jack JonesCecil Lynch2012AbdulMalik ShakirDiane WoldSub Dubman7* Chair
8 Current Organization of the BRIDG SCC CDISCcaBIGHL7FDABRIDGSemantic Coordination CommitteeSemantic Coordination Committee (SCC)Responsible for ongoing model maintenanceHarmonizes subdomain projects into the main modelSource: Doug Fridsma
9 Semantic Coordination Committee (SCC) NameAffiliationCharlie MeadNCI / Booz & CompanySteve SandbergNCI / ScenPro, Inc.Mike WoodcockNCI / Mayo ClinicSmita HastakWendy Ver HoefBecky AngelesJulie EvansCDISCLloyd McKenzieNCI / Gordon Point Informatics99
11 Perspectives of BRIDGCanonical Perspective Domain Analysis Model (DAM), comprehensive UML model with packages for each sub-domainSME Perspectives Domain friendly business models, separate UML model for each sub-domainAdverse EventCommonProtocol RepresentationRegulatoryStudy ConductOntological Perspective (Future) Model used for semantic validation and inferencing, several OWL-DL representationsHL7 Perspective Formal binding to the HL7 RIM, central DMIM-like diagram with supporting diagrams, modeled in HL7 v3 graphical style
12 Perspectives of BRIDGRecognize and support the different types of BRIDG usersEach perspective is intended for a different audienceEach perspective is a representation of the same semantics
13 BRIDG Canonical Perspective Comprehensive Domain Analysis Model (DAM)Intended for information analystsSingle UML modelModeled and managed in Enterprise Architect
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-domainModeled and managed in Enterprise ArchitectAutomatically 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 VisioSingle DMIM-like modelMaps to UML-based modelManually generated from Canonical Perspective
22 BRIDG as a global, public standard CDISC Review and Comment Process resulted in BRIDG as a CDISC standard in January 2010ISO 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 2010ISOHL7CDISC
23 (starting with most recent release) BRIDG Content – 1(starting with most recent release)ReleaseProjectStakeholderR3.0.3Clinical Data Acquisition Standards Harmonization (CDASH) V1.1CDISCStudy Data Tabulation Model (SDTM) V3.1.2Integrated Case Safety Report (ICSR) R2FDAR3.0.2caBIG® Central Clinical. Participant Registry (C3PR) v2.9NCICancer Adverse Event Reporting System (caAERS) v2.2Patient Study Calendar (PSC) v2.6LabViewer v2.2R3.0.1Clinical Trials Registration and ResultsHL7 RCRIMR3.0(Architecture Redesign only)
24 BRIDG Content - 2 Release Project Stakeholder R2.2 CDISC HL7 Message Study Design (partial)FDACDISC HL7 Message Study ParticipationR2.1Clinical Trial Registry (COPPA, ct.gov, WHO, PRV1.0)CDISC, NCIProtocol Abstraction (COPPA – Correlations, Organizations, People and Protocol Abstraction)NCIR2.0Adverse EventsCDISC, NCI, NIH, US Federal Gov’t, FDAPlayer / Scoper for Person and OrgNCI, CDISCPatient Registry (C3PR)R1.1Study Data Tabulation Model (SDTM)CDISCTrial Design ModelR1.0Regulated Product Submission (RPS)FDA/HL7 RCRIMPatient Study Calendar (PSC)Clinical Trial Object Model (CTOM)caXchange/LabHubNCI/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 ArchitectThe industry-standard language for specifying, visualizing, constructing, and documenting the requirements of software systemsThe BRIDG model uses these UML diagrams:Class diagramsInstance diagramsState transition diagrams
27 UML Class Diagramsclass – a concept of primary importance the domain-of-interest, depicted as a rectangle labeled with the concept’s nameattribute (including datatype specification) – a descriptive feature of a class, depicted as being contained within the classrelationship – one of several types of “lines” between classes
28 Class diagram example class attribute data type relationship multiplicitydata type
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
39 User’s Guide Section 1: Guide to the Reader Section 2: Executive SummarySection 3: The BRIDG Project and BRIDG ModelSection 4: The BRIDG Model: General Considerations and Representational ConventionsSection 5: Model ContentSection 6: GlossarySection 7: Appendix
40 Release Notes Table of Contents 1 Executive Summary 1.1 BRIDG ISO Joint Initiative Council (JIC) Ballot1.2 BRIDG Definition1.3 BRIDG Project Stakeholders1.4 BRIDG Project Goals1.5 Definition of BRIDG Model Domain of Interest2 What’s New in Release 22.214.171.124 General changes in Release 126.96.36.199 Detailed Change Lists for Release 3.0.13 Files in R3.0.1 Package3.1 UML-Based Models3.2 RIM-based Models3.3 Report of Comprehensive UML-Based Model3.4 XMI of Comprehensive UML-Based Model3.5 Release Notes (this file)3.6 User’s Guide3.7 BRIDG Domain Analysis Static Model Style Guide3.8 BRIDG CDISC Comment Resolution Spreadsheet4 Known Issues
41 UML-based Model: Mappings to Source Projects Enterprise Architect
42 UML-Based Model Mappings to Source Projects RTF Report 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 AbstractSimple: Character, String, Text, NumericBRIDG uses ISO data type specification
44 Datatypes: Complex ISO 21090: Healthcare Data Types ST = String CD = Concept Descriptor (Coded Concept)DSET = unordered collection, unique valuesED = Encapsulated dataURG = Uncertain RangeRTO = RatioII = Instance IdentifierSome CD properties:displayNameoriginalTextcodecodeSystemNamecodeSystemVersionvalueSetAnd more
45 Interfacing with Controlled Vocabularies Plans to move BRIDG semantics into a controlled environment such as NCI’s EVS / caDSRBRIDG 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 listsProject Team involves BRIDG SCC earlyReps from project team meet with SCC toharmonize the project model into the BRIDGUpdated BRIDG Domain Analysis Model is createdThe 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 internetThe gForge site:Release FilesNewsBug and enhancement trackersWork in progress in Subversion
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