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  • Talking Points:Areas covered include but are not limited to: protocols, studies, study sites, organization and org roles, people and people roles, study subjects, study activities (e.g. subject enrollment, specimen collection, lab work, etc.) , products, study design, documents, regulatory artifacts
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    • 1. Standards Influenced Research Information Systems InteroperabilitySession One: Information Modeling
      AbdulMalik Shakir, Information Management Strategist
      City of Hope, Duarte, CA
    • 2. About Me
      Abdul-Malik Shakir
      Information Management Strategist with City of Hope
      Principal Consultant with Shakir Consulting
      HL7 Member since 1991
      Co-Chair of the HL7 Education Workgroup
      Member of the HL7:
      Architectural Review Board
      Public Health and Emergency Response Workgroup
      Regulated Clinical Research Information Management Workgroup
      Modeling and Methodology Workgroup
      Member of the BRIDG Board of Directors since January 2010
      Modeling Facilitator for CTR&R, SAP, STDM, and caEHR
      May 2010
      2
      Standards Influenced Research Information Systems Interoperability
    • 3. Research Informatics Systems Engineering
      May 2010
      3
      Standards Influenced Research Information Systems Interoperability
    • 4. Session Overview
      Domain Analysis Modeling
      The Value of Modeling
      What is a Domain Analysis Model (DAM)
      What is the Unified Modeling Language (UML)
      Biomedical Research Integrated Domain Group (BRIDG – Domain Analysis Model)
      HL7 Clinical Trail Registration & Results DAM
      Requirements Gathering
      BRIDG DAM Mapping
      BRIDG Subset Definition
      COH Semantic Interoperability Infrastructure
      Metadata Services
      Terminology Services
      Ontology Services
      Rule Services
      May 2010
      4
      Standards Influenced Research Information Systems Interoperability
    • 5. Domain Analysis Modeling
      PARTY IDENTIFICATION NUMBER
      PARTY
      PARTY ACTIVITY ROLE
      Identification Number
      Begin Date
      Issuing Authority Name
      End Date
      Issue Begin Date
      Role Code
      Issue End Date
      CASE DEFINITION
      PARTY CASE DEFINITION ROLE
      Type Code
      Begin Date
      Begin Date
      Category Code
      End Date
      Description
      Role Code
      End Date
      PATIENT COVERAGE
      Name
      Provider Code
      PARTY CASE ROLE
      Begin Date
      End Date
      Role Code
      BILLING ACCOUNT
      PARTY NOTIFICATION
      CASE
      Begin Date
      Begin Date
      End Date
      Confirmation Method Code
      PARTY TO PARTY ASSOCIATION
      Notification Receiver Identification Number
      Count
      Notification Sender Identification Number
      Begin Date
      Count Type Code
      Code
      Detection Method Code
      End Date
      End Date
      Identification Number
      Transmission Mode Code
      Status Code
      Status Date
      PUBLIC HEALTH NOTIFICATION
      Begin Date
      End Date
      Identification Number
      Reason Code
      ORGANIZATION
      INDIVIDUAL
      Entity
      Alias Name
      Name
      Name
      Type
      Type Code
      Outbreak
      Begin Date
      DIAGNOSIS
      End Date
      PARTY CONDITION
      Classification Scheme Code
      Extent Code
      Disease Code
      Begin Date
      Peak Date
      Diagnosis Code
      Description
      Diagnosis Date
      End Date
      Source Code
      Name
      Source Text
      Name Status Text
      PERSON
      NON PERSON LIVING ORGANISM
      INFORMAL ORGANIZATION
      Formal Organization
      Status Date
      OUTBREAK STATISTIC
      Birth Date
      Genus Name
      Industry Code
      Death Date
      Species Name
      Amount
      Ethnicity Code
      Category Code
      PARTY LOCATION ROLE
      Race Code
      Type Code
      Begin Date
      Sex Code
      End Date
      Soundex Text
      Role Code
      Occupation Name
      Status Code
      Status Date
      PARTY SPECIMEN ROLE
      PERSON NAME
      Begin Date
      Degree Name
      End Date
      First Name
      Role Code
      Last Name
      Middle Name
      Prefix Name
      Suffix Name
      Type Code
      PARTY VEHICLE ROLE
      Begin Date
      End Date
      Role Code
      VEHICLE
      HEALTH RELATED ACTIVITY
      Description
      Begin Date Time
      Name
      Disposition Date Time
      (Implication) Status Code
      Disposition Description
      Status Date
      End Date
      Type Code
      Identification Number
      Notification Indicator
      Priority Code
      Source Type Code
      DISEASE ASSOCIATION
      Type Code
      LOCATION
      Disease Code
      Address
      Disease Imported Code
      Identification Number
      Etiologic Status Code
      Name
      Etiologic Status Date
      VEHICLE CONDITION
      Setting Code
      Exposure Begin Date
      Type Code
      Description
      Exposure End Date
      Description Status Code
      Infection (or Illness) Type Code(s)
      Status Date
      SPECIMEN LOCATION
      Begin Date
      End Date
      TEST REFERENCE TABLE
      Method Code
      Name
      Samples Required Number
      Samples Required Unit Code
      SPECIMEN
      Type Code
      Collection Date
      DISEASE CAUSING AGENT
      Description
      Agent Type Code
      TEST
      Identification Number
      HEALTH STATUS INQUIRY
      INTERVENTION
      Agent Name
      REFERRAL
      Name
      Amount
      Amount
      Referral Basis Code
      Source Code
      Amount Unit Code
      Amount Number
      Referral Type Name
      Type Code
      Begin Date
      Amount Unit Code
      Referral Acceptance Code
      Description
      Description
      Description Code
      Duration
      ADDRESS
      TELEPHONE
      Duration
      Duration Unit Code
      Begin Date
      Telephone Type Code
      Duration Unit Code
      Enrollment Code
      City Name
      Area Code
      End Date
      Enrollment Type Code
      Country Name
      Number
      Live Births Number
      Manufacturer Lot Number
      County Name
      Manufacturer Lot Number
      Manufacturer Name
      End Date
      Manufacturer Name
      Name
      Postal Code
      Reason Text
      Route Code
      TEST RESULT
      CODE
      Status Date
      Result Date
      Status Code
      Amount
      State Code
      Code
      Result Text
      Status Date
      Amount Unit Code
      Street Address Text
      Description
      Status Code
      Code
      Type Code
      Coding System Name
      Status Date
      Date
      Travel Country Name
      Description
      Type Code
      Description Code
      May 2010
      5
      Standards Influenced Research Information Systems Interoperability
    • 6. Why Model
      To aid in understanding relevant functions and information needs of a particular domain
      To communicate the modeler’s understanding of the domain and allow that understanding to be assessed by others
      To aid in reconciling multiple perspectives of a domain by combining varying perspectives into a single specification
      To document a solution design (existing or planned) so that the design may be evaluated
      May 2010
      6
      Standards Influenced Research Information Systems Interoperability
    • 7. Do you
      play
      football?
      Yes, I do
      play
      football.
      Revealing assumptions is an essential component of effective communication.
      Data models are an effective means of documenting our assumptions
      about a domain
      Reveal Assumptions
      May 2010
      7
      Standards Influenced Research Information Systems Interoperability
    • 8. Reduce Ambiguity
      A
      B
      0..*
      1
      0..*
      0..*
      C
      Modeling provides a language that allows us to unambiguously express our understanding and assumptions about the actions and information of interest in a particular domain
      May 2010
      8
      Standards Influenced Research Information Systems Interoperability
    • 9. Reconcile Conflicts
      X
      B
      A
      B
      0..*
      0..*
      1
      1
      0..*
      0..*
      0..*
      0..*
      C
      C
      Sharing models provides
      an opportunity to identify and reconcile conflicts in our understanding
      and to validate our assumptions.
      May 2010
      9
      Standards Influenced Research Information Systems Interoperability
    • 10. Expand Understanding
      A
      B
      A
      B
      0..*
      1
      0..*
      0..*
      0..*
      1
      0..*
      0..*
      C
      D
      Sharing models also provides
      an opportunity to identify gaps in our understanding.
      No one of individual has the complete view of domain of interest.
      May 2010
      10
      Standards Influenced Research Information Systems Interoperability
    • 11. Consolidate Ideas
      A
      B
      X
      B
      A
      B
      0..*
      1
      0..*
      0..*
      0..*
      1
      0..*
      1
      0..*
      0..*
      0..*
      0..*
      C
      D
      C
      B
      G
      E
      0..*
      1
      0..*
      1
      0..*
      1
      D
      X
      F
      C
      A
      0..*
      0..1
      0..*
      1
      Model I
      Model II
      Model III
      May 2010
      11
      Standards Influenced Research Information Systems Interoperability
    • 12. Value of Modeling
      Reveal Assumptions
      Reduce Ambiguity
      Reconcile Conflicts
      Expand Understanding
      Consolidate Ideas
      May 2010
      12
      Standards Influenced Research Information Systems Interoperability
    • 13. What is a Domain Analysis Model
      A Domain Analysis Model (DAM) is a conceptual model used to depict the behavioral and static semantics of a domain of interest.
      A DAM provides an opportunity for subject matter experts (SMEs) within a particular domain to integrate and harmonize their perspectives regarding the use cases, activities, and information needs of their shared domain.
      A DAM is particularly useful when used in a domain with broad interests and a diverse population of SMEs.
      13
      May 2010
      Standards Influenced Research Information Systems Interoperability
    • 14. Domain Analysis Model Use
      A domain analysis model is used as reference material in development of information system interoperability specifications as well as design specifications of information system components
      The DAM is a requirement specification and is the primary artifact from which information system design specifications are derived.
      The preferred language for expression of a domain analysis model is UML.
      14
      May 2010
      Standards Influenced Research Information Systems Interoperability
    • 15. Unified Modeling Language (UML)
      UML is a standardized general-purpose modeling language in the field of software engineering.
      UML is not a development method; however, it was designed to be compatible with the leading object-oriented software development methods.
      UML includes a set of graphical notation techniques to create visual models of software-intensive systems.
      15
      May 2010
      Standards Influenced Research Information Systems Interoperability
    • 16. UML Diagram Types
      May 2010
      16
      Standards Influenced Research Information Systems Interoperability
    • 17. Domain Analysis Model Diagrams
      17
      May 2010
      17
      Standards Influenced Research Information Systems Interoperability
    • 18. Biomedical Research Integrated Domain Group
      18
      May 2010
      Standards Influenced Research Information Systems Interoperability
    • 19. From Data Requirements to HL7 Message
      May 2010
      19
      Standards Influenced Research Information Systems Interoperability
    • 20. Requirements Mapping to BRIDG
      May 2010
      20
      Standards Influenced Research Information Systems Interoperability
    • 21. BRIDG Subset to CTRR DAM
      May 2010
      21
      Standards Influenced Research Information Systems Interoperability
    • 22. CTRR DAM to CTRR HL7 Message RMIM
      May 2010
      22
      Standards Influenced Research Information Systems Interoperability
    • 23. CTRR HL7 Message RMIM to HMD
      May 2010
      23
      Standards Influenced Research Information Systems Interoperability
    • 24. CTRR HL7 MESSAGE HMD TO CTRR.XSD
      May 2010
      24
      Standards Influenced Research Information Systems Interoperability
    • 25. From Requirements to HL7 Message
      May 2010
      25
      Standards Influenced Research Information Systems Interoperability
    • 26. May 2010
      26
      Standards Influenced Research Information Systems Interoperability
    • 27. Semantic Interoperability Infrastructure
      May 2010
      27
      Standards Influenced Research Information Systems Interoperability
    • 28. May 2010
      28
      Standards Influenced Research Information Systems Interoperability
    • 29. AbdulMalik Shakir
      Information Management Strategist
      City of Hope
      1500 E. Duarte Road
      Duarte, CA 91010
      Office: (626) 256-4673 x63160
      Mobile: (626) 644-4491
      Email: AShakir@COH.org
      May 2010
      29
      Standards Influenced Research Information Systems Interoperability

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