Interchange vs Interoperability

1. Interchange vs Interoperability Syntax  StructureSemantics  Meaning • Main Entry: in·ter·op·er·a·bil·i·ty: ability of a system ... to use the parts or equipment of another systemSource: Merriam-Webster web site • interoperability: ability of two or more systems or components toexchange information and to predictably use the information that has been exchanged. • Source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990] Semanticinteroperability Syntacticinteroperability (interchange) Source: Charles Mead, MD, HL7

2. Computerized doesn’t mean syntactic interoperability 6 1 5 2 3 4

3. Concept 1 Concept 2 “We need to sign off on the protocol by Friday” • “Protocol XYZ has enrolled 73 patients” Thing 1 Thing 2 Study Document Concept 3 Thing 3 “Per the protocol, you must be at least 18 to be enrolled” Plan Semantic interoperability: “Protocol” and the Semiotic Triangle Symbol “Protocol” Source: John Speakman/Charlie Mead

4. Semantic Interoperability • To understand the data being received you must know both: • The definition of each element of data, and its relationship with each of the other elements • you must have a semantic model of the data and • The terminology to be used to represent coded elements, including the definitions, and relationships within the terminology Source: HL7

5. Current Organization of the BRIDG project FDA HL7 • BRIDG Advisory Board • Representation from the current stakeholders • Help to allocate priorities and identify resources • Assist with vetting the model in the various constituents • Technical Harmonization Group • Responsible for ongoing model maintenance • Developing shared harmonization processes • Multiple subdomain projects • Representation from pharmaceutical companies, technology companies, government agencies, and cancer centers CDISC caBIG NCI PhRMA BRIDG Advisory Board CDISC caBIG HL7 BRIDG Technical Harmonization Group

6. Study calendar (caBIG) BRIDG model EudraCT FastTrack Protocol Authoring & Trial Design SDTM (CDISC) SDTM (CDISC) CONSORT (cancerGRID) Protocol Registration CTOM (caBIG) WHO ODM (CDISC) JANUS (IBM) Clinical Trials Operations HL7 (M Walker) PDQ ClinicalTrials.gov SDTM (CDISC) Adverse Events JANUS (IBM) caAERS (caBIG) SDTM (CDISC) LabSpecification FDA (M. Walker) caBIG NCI Lab SIG (caBIG) HL7 (M Walker) eDCI Oracle CTLab std (CDISC) CDISC ODM BRIDG projects and contributors

7. Model organization • Dynamic View • Captures the business process decomposition of the lifecycle of clinical trials research

8. Behavioral Aspects of BRIDG

9. Behavioral Aspects of BRIDG Roles are defined in the swim lanes with examples drawn from discussions with the domain experts

10. Behavioral Aspects of BRIDG The activities are described in activity diagrams that can be drilled down to provide additional detail. These are linked to the static (logical) portions of the model

11. Model organization • Logical View • Contains three core packages • Harmonized elements • Staging Area • Manual review area • Addition resources • HL7 V3 RIM • Contains the semantics for the static objects (data) that is used in clinical trials research • Currently have 9 subdomain models in the process of harmonization

12. Current Classes in Core Elements cd Comprehensive Class-only diagram Participation Study +are performed by StudyInvestigator +participate in +participate as +participate in Investigator 1 0..* Person Role +is fulfiled by Participation PersonRole the role +have StudyAuthor +are +are written by attributed to Participant +are performed at Participation 1 StudySite +write Document StudyDocument PlannedStudy 0..* +describes 1 1 1 1 +are assigned by +is described by Organization Role HealthCareSite +have OrganizationRole +are 1..1 +assign +is described by 0..1 attributed 0..* to Participation +is operationalized by SubjectAssignment 0..1 PerformedStudy FundingSponsor Participation TherapeuticAgent 0..* 1 StudyAgent Role +have Material 1 0..* MaterialRole +are attributed Activity Activity to +is operationalized by PerformedActivity PlannedActivity 1..1 0..1 +is described by Device Drug

13. Harmonized BRIDG elements

15. Models in the staging area

16. Harmonizing attributes

17. Adding tags to provide semantic traceability (and notes)

18. Simple semantic can be tracked in tagged values

19. This linking can be extended down to the CDE level

20. More complex relationships

21. Application Development V3 Message Development xml data Exchange HL7 Tooling caCORE Tooling CDISC xml Interoperability Interoperability HL7 (RCRIM) CDISC NCI/caBIG FOUNDATION MODEL BRIDG – Domain Analysis Model for Clinical Research Achieving interoperability IMPLEMENTATION SOLUTIONS STAKEHOLDERS

22. Cumulative Registered Users

23. Project Team Activities Items for submission – POC, Project Name, project description, high-level project schedule, project Sponsor, etc. Register Project with BRIDG & submit Project info. BRIDG THC assigns Mentor A BRIDG mentor will be assigned to your project Download BRIDG Replica Begin modeling using BRIDG replica and follow BRIDG guidelines Refer to best practices for modeling in BRIDG environment Submit BRIDG Harmonization Package to THC Harmonization Package artifacts – the EAP file, package level xmi Export, Modeling analysis & harmonization document) Submit BRIDG Harmonization Package to THC Meet with BRIDG THC to harmonize project model (virtual or F2F meeting)

24. BRIDG THC Activities Review the Project Registration material. Assign Mentor to project BRIDG mentor will be available to answer questions Take project to BAB and assign priority and timeline for harmonization Inform Project POC May require some negotiations based on other efforts Review harmonization Package submission Perform analysis and prepare for harmonization meeting Schedule project Harmonization meeting Develop harmonization Results package for project team

25. Further Information • www.CDISC.org • ncicb.nci.nih.gov • caBIG.nci.nih.gov • www.BRIDGproject.org • fridsma@cbmi.pitt.edu • jevans@cdisc.org