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caBIG—A Primer for Medical Informatics

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caBIG—A Primer for Medical Informatics Powered By Docstoc
					The BRIDG model: a shared domain analysis
model of regulated clinical research




Douglas B. Fridsma, MD, PhD, FACP
Center for Biomedical Informatics
Center for Pathology and Oncology Informatics
University of Pittsburgh
Acknowledgements –leadership


• Leadership and collaboration
   –   CDISC board members
   –   Becky Kush, CDISC
   –   Sue Dubman, NCI
   –   Charlie Mead, HL7
   –   Barbara Tardiff, Linda Quade, Randy Levine, RCRIM
       technical committee of HL7
Acknowledgements –modelers

•   Ed Helton             • BRIDG group
•   Pierre-Yves Lastic       –   Christo Andonyadis
•   Tony Friebel             –   Greg Anglin
•   Don Kacher               –   Lisa Chatterjee
•   Barbara Tardiff          –   Julie Evans
•   Chuck Jaffe              –   Douglas B Fridsma
•   Frank Newby              –   Smita Hastak
•   Sally Cassels            –   Joyce Niland
•   Nitin Gupta              –   John Speakman
•   Landen Bain              –   Cara Willoughby
•   Laura Altshuler          –   Diane Wold
•   Steve Ruberg             –   Peter Ambramovich
•   Elaine Job
•   Becky Kush
•   Sylvia Collins
•   Udo Siegman
•   David Hardison
•   David Iberson-Hurst
Organizational Involvement

• Pharmaceutical companies
   –   AstraZeneca
   –   Boehringer-Ingelheim
   –   Eli Lilly
   –   Glaxo Smith Klein
   –   Merck
   –   Novartis
   –   Pfizer
   –   Sanofi-Aventis
• Technology companies
   –   IBM
   –   SAS
   –   Fast track
   –   SAIC
   –   BAH
   –   Oracle
The Pillars of (Semantic) Interoperability
               Necessary but not Sufficient


• Common model across all domains-of-interest
   – The structured protocol representation in BRIDG
• Model grounded on robust data type specification
   – Common data elements in the caDSR
• Methodology for binding terms from concept-
  based terminologies
   – UML loader, semantic connector
• A formally defined process for defining specific
  structures to be exchanged between machines,
  i.e. a “messaging standard”
   – HL7 and implementation specifications
   – caBIG unified process/model driven architecture
                                                            Acknowledgements:
Standards – Why?                                            Landen Bain, CDISC
Cancer Research: Two Different Worlds




                     Patient
                     Data in
                   Proprietary
                     Format
                                 BRIDG


       Patient Care World                Clinical Research World

 • Multiple data sources and types   • Protocol defines define elements
 • HL7 is a pervasive standard       • Linear data flow
 • Data are organized around the     • CDISC is the emerging standard
   patient                           • Data are organized around a trial
What is BRIDG?


• An open community of stakeholders interested in developing
  standards for exchanging information about clinical trials
    – HL7 Domain analysis model in Regulated Clinical Research
      (RCRIM) technical committee
    – caBIG analysis model for model-driven development
    – CDISC integrating model for current standards
• A bridge between
    – clinical trial domain experts and technical experts
    – different models of clinical trials information
• A formal model of the shared semantics of regulated clinical
  trials research
• The semantic foundation for application and message
  development in HL7, caBIG, and CDISC
“Protocol” and the Semiotic Triangle

          Concept 1                                         Concept 2
     “We need to sign off on                            “Protocol XYZ has enrolled
     the protocol by Friday”                                   73 patients”




Thing 1                              Symbol                              Thing 2
Document                        “Protocol”                              Study



          Concept 3
                                                           Thing 3
   “Per the protocol, you must be
     at least 18 to be enrolled”                             Plan

                   Source: John Speakman/Charlie Mead
 The Communication Pyramid:
 Communicating complexity is HARD

• How do you link the people who know about clinical oncology
  (domain experts) with the technology implementers who will develop
  tools to support clinical work so that we have semantic
  interoperability?

• The Problem Space (Domain Space)
   – A structured way to describe and document the information requirements
     of a particular area of interest
   – “What”
   – Discovered through Analysis
• The Solution Space (Implementation/Technical Space)
   – “How”
   – Discovered through Design
   – One Problem  Many Solutions

• The domain analysis model (SPR) is a bridge between domain
  experts and technical experts
The Communication Pyramid

                  Domain Analysis Model (SPR)

                   Non-standard Graphics

                     ad hoc Drawings


                  Structured Documents


                  Free-text Documents
                           `
                     Discussions


  Communication                Source: Charlie Mead, MD, HL7
              “The Map is not the Territory”
                            (Bertrand Russell)


•   Domain Experts have a “mental map” of the Problem Space
    – Noam Chomsky “Syntactic Structures” (1975)
       •   Deletion (filtered/missing details)
       •   Distortion (incorrect or modified details)
       •   Generalization (abstractions via rules, beliefs, principles)
       •   Distortion and Generalization share…
       •   … Inappropriate/incorrect use of universal qualifiers
             –   All
             –   Everyone
             –   Always
             –   Never
             –   Nobody
             –   None
           The Map is not the Territory

•   Deletion – “They use the system to borrow books.”
    – Challenge: “Who uses the system to borrow books?”
    – Response: “Library members, librarians, other libraries.”

• Distortion – “Borrowers can‟t borrow another book until all
  overdue books are been returned.”
    – Challenge: “Are there any circumstances where a borrower can
      borrow a book before all overdue books are returned?”
    – Response: “Yes, two circumstances….”

• Generalization – “Everyone must have a ticket to borrow
  books.”
    – Challenge: “Are there any system users that can borrow books
      without a ticket?”
    – Response: “Librarians and other libraries have a different type of
      ticket.”
What Is A Domain Analysis Model?

• “An implementation-independent view of the Problem Space
  from the Domain Expert’s perspective”

•   Minimum components
    – Static View
        •   Concepts, Attributes, Relationships
        •   Complete, unambiguous documentation (GLOSSARY)
        •   UML Class Diagram
        •   Appropriate partitioning of sub-domains and layers 0f abstraction (Packages)
        •   Exemplar Instance Diagrams
    – Dynamic View
        • Storyboards
        • UML Activity Diagram representations of Storyboards
        • State diagrams of suitably „interesting‟ static classes
    – In the end, if the model‟s collective view unambiguously specify the
      Problem‟s semantics (dynamic and static), the „correct‟ views have been
      constructed
         Vision of the SPR SIG in caBIG


• To define a computable protocol representation that
  supports the entire life-cycle of clinical trials protocol,
  and develop tools that use these protocol
  representations. These tools should be standards-
  based, caBIG compliant and assist users in creating,
  maintaining, and sharing clinical trials information.
• The clinical trials protocol representation will serve as
  a foundation for caBIG modules that support all
  phases of the clinical trials life cycle, (including
  protocol authoring) and be developed to meet user
  needs and requirements.
         Vision of the SPR SIG in caBIG


• To define a computable protocol representation that
  supports the entire life-cycle of clinical trials protocol,
  and develop tools that use these protocol          BRIDG
  representations. These tools should be standards-
  based, caBIG compliant and assist users in creating,
  maintaining, and sharing clinical trials information.
• The clinical trials protocol representation will serve as
  a foundation for caBIG modules that support all
  phases of the clinical trials life cycle, (including
  protocol authoring) and be developed to meet user
  needs and requirements.
     Domain Space Analysis Model: Timeline



  2001-2002         2003        Jan 2004         Mar-Aug 2004        Aug-Oct 2004         Nov 2004             Dec 2004




 Early attempts              Dr. Mead’s Report    Initial DSAM       Feedback Review     Initial Modeling of     Begin Mapping
to map ODM to
   HL7 RIM         ...      to CDISC Board of
                                  Directors
                                                 Development, by
                                                    Dr.Mead
                                                                       of DSAM with
                                                                      Focus Groups
                                                                                         Protocol Elements
                                                                                               in DSAM
                                                                                                                 CDISC ODM to
                                                                                                                  HL7 V3 RIM

                                                                                                                  Involvement
Reps from:                                       Reps from:          Reps from:          Reps from:
                                                 •CDISC Board        •NIH/NCI                                     from:
•CDISC                                                                                   •CDISC
                                                 •CDISC Teams        •FDA                                         •CDISC
•HL7                                                                                     •NCI/caBIG
                                                 •HL7 RCRIM          •EHR/eSource                                 •NCI
                                                                                         •HL7 RCRIM
                                                 •TCC                •TCC                                         •RCRIM inv.
      HL7 V3 RIM Implementation of               •NCI                •HL7 RCRIM
          CDISC LAB Model ->                                         •CDISC teams
                                                                     •CDISC IAB
           ANSI Accreditation;

         Assistance for ODM sought
            from L.Bain, C.Mead                    SDTM Announced by HHS/FDA;
                                                   eSubmission made w/ define.xml


                                     ODM Production V1.2 (XML Schema) - Industry Adoption and Tool Development 
Merging the caBIG and CDISC projects


• Fall 2004 – caBIG identified “best of breed”
  models in the CDISC standards and HL7
  messages
• November 2004 – First joint
  CDISC/HL7/caBIG modeling session
• Between November 2004 and March 2005
  – multiple modeling sessions to develop the
  “scaffolding” of the domain analysis model
  (SPR)
Community review

• Since then, model has been reviewed by a number of
  caBIG and HL7 members
• Changes to the model based on the review and
  anticipated future harmonization tasks
• Have begun work on the business process
  decomposition (with primary focus on pharmaceutical
  processes)
   –   Cara Willoughby
   –   Greg Anglin
   –   Diane Wold
   –   Joel Hoffman
   –   (and others)
Feedback from the initial BRIDG
model
•   Linda Quade, Mead Walker, Charlie Mead, others
•   The model is big, complex, and difficult to navigate
•   The scope of the model is ill-defined
•   The levels of abstraction are inconsistent
•   The model is static heavy, and needs additional work
    on the dynamic aspects of the model, linked to the
    static structures
Restructuring BRIDG

• Moved much of the old parts of the model that reflect
  the evolution of our thinking to a separate package
• Created a structure in the model that is similar to the
  RIM backbone to help organize the model
   – Recognized that Entities and Roles will be relatively stable,
     but the real complexity will be in the activities and (possibly)
     the participations
• Created “views” that reflect smaller parts of the model
• Staging area in the model for parts of the model that
  are in the process of harmonization
Current projects in BRIDG


• Models being staged for harmonization

   – Clinical Trials Object Model (CTOM) from NCI (90%)
   – SDTM from CDISC (20%)
   – caAERS from City of Hope AND Patient Safety model from
     HL7 (pending, mid-Feb)
   – eDCI model from NCI/Oracle (pending)
BRIDG Sub-Projects

• Trial Design Model

      • Based on CDISC and FDA/Janus standard
      • Developing common concepts and understanding for arms,
        treatment groups, visits, cycles, courses, etc.
      • At present, input from Pharmaceutical companies thru CDISC
        and FDA


      • Current Status –
          – Recently worked with CDISC SDTM team to model SDTM
            requirements
          – Plans to harmonize with BRIDG
Example: Dissimilar Arms
                                                       Epoch

      Screen           Run-In            Treatment              Follow-up
                                                              Arm
                    Arm segment

                                  Trt Phase 1   Trt Phase 2     Follow-up

      Screen           Run-In

                                       Standard Care            Follow-up




 Source: Diane Wold - GSK
BRIDG Sub-Projects (cont’d)
   Statistical sub-Model

     • Based on CDSIC Statistical specification – ADaM (Analysis
       Data set Model
     • ADaM provides models for commonly used statistical analysis
     • Some early classes in this UML diagram are: Hypothesis,
       Analysis, SampleSizeJustification, AnalysisSetCriterion, etc.
     • Current Status –
         – very early development of the model
         – Input only from Pharmaceutical and CRO
                 Statistical Model (work-in-progress
cd DraftStatisticsPhilly

   Name:       DraftStatisticsPhilly
   Author:                             Note: Green means we understand these classes and they are represented (either in the analysis model or                                                                                             Note: TimingFunction and
   Version:    1.0                     instance diagrams) elsewhere in the model.                                                                                                                                                          SequenceOfAnalyses will probably be
   Created:    3/15/2005 2:06:25 PM                                                                                                                                                                                                        subsumed by the PlannedAnalysisEvents as the
   Updated:    3/29/2005 3:31:00 PM                                                                                                                                                                                                        ActivityManagementPlan model is fleshed out.
                                                                                    Concepts::StudyObjectiv e (the "what")
                                                                                                                                                                                                         SequentialAnalysisStrategy
                                                                          +    description: PSMDescription
                                                                          +    intentCode: SET ENUMERATED                                                                                                +   alphaSpendingFunction:                 Note: The various plans (PlannedAnalysisEvents,
                                                                          +    objectiveType: ENUM{Primary,Secondary,Ancillary}                                                                          +   timingFunction:                        DataSafetyMonitoringBoardPlan, DosingPlan,
                                                                          +    id: PSMID                                                   PlannedAnalysisEv ents                                        +   sequenceOfAnalyses:                    SiteMonitoringPlan, AccrualPlan, DataManagementPlan,
                                                                                                                                                                                                         +   trialAdjustmentRule:                   InvestigationalPharmacyPlan etc) draw upon the activites in
                                                                                                                                                                                                                                                    Activity and perform some kind of management on it. A given
                                                                                                                                                                                                                                                    plan may hve both scheduled/determined activities and
                                                                                                                                                          *
                                                                                                                                                                                                                                                    contingent activities with associated triggers.
                                                                                                                                                                                                               CompoundAnalysis
                                                                  StatisticalInference                                                                                                      -_Analysis
                                                                                                                                                                                                                                                                                      StatisticalMethod
                                                                                                                                                   Analysis
                                                                                                                                                                                            *
                                                                                                                                                                                                                                                                               +   algorithm:
                                                                                                                             +   description: PSMDescription
                                                                                                                                                                                                                   AtomicAnalysis                                              +   description: PSMDescription
                                                                                                                             +   analysisType: SET ENUM
                                                                                                                                                                                                                                                                        1      +   inputAnalysisVariables: SET
                                                                                                                             +   analysisRole:
                                                                                              -_Hypothesis                                                                                                                                                  0..1               +   summaryStatistics: SET
                                                                                                                             +   rationaleForAnalysisApproach: PSMDescription                                                             0..1
                                                                                              *                                                                                                                                                                                               *
                                                                       Hypothesis

                                                                  + statement: TEXT                                                                  -_StatisticalAnalysisSet   *                                   1
                                                                                                                                                                                                                                      StatisticalModel

                                                                                                                                                                                                                             + description: PSMDescription

                                                                                                                                 SampleSizeJustification                            StatisticalAnalysisSet
                                                                                                                                                                                                                                                                                              *
                                                                                                                          + analysisBeingSupported: Analysis                + description: PSMDescription
                                                              *
                                                                                                                          + sampleSizeCalculation: Analysis                                                                                                                         AnalysisVariable
                                                                                                                          + clinicalJustification: TEXT                                            *                                StatisticalAssumption
                                                                              Alternativ eHypothesis                                                                                               *                                                                           + name: TEXT
                                                                                                                                                                                                                             + description: PSMDescription                     + value:
                                                      NullHypothesis
                                                                                                                                                                                     AnalysisSetCriterion                                                                      + controlledName: ENUM

                                                                                                  1
                                                                                                                                                                                                   SummaryStatistic

                                                                                                                                                                                                                                                                                      Measurement
                                                                                                                                  HypothesisTest
                                                                                                                                                                                        *
                                                                                                       +   significanceLevel:
                                                                                                       +   rejectionRegion:                                                                                    *
                                                                                                       +   testStatistic:
                                                                                                       +   comparisonType: ENUM{Superiority,Equivalence,Non-Inferiority}
BRIDG Sub-Projects (cont’d)

     Clinical Trial Registry
    • Objective: To define requirements for registering a clinical trial in a
      clinical trial repository
    • Requirements being developed by NCI and CDISC
    • Working with PDQ, clinicaltrials.gov and European EUDRACT
    • Have recently established collaboration with the WHO activity of
      clinical trials registry
        • Becky Kush (CDISC president) on the advisory board
        • Jan 25-28 – harmonization session in Washington DC with
          CDISC/HL7/WHO models
        • Working with cancerGRID to incorporate and make explicit the CONSORT
          model

    • Current Status –
              •   Group has defined a list of 70 elements
              •   Planning to model these into BRIDG
              •   Planning on developing a HL7 v3 message
              •   POC – Lakshmi Grama, NCI
BRIDG Sub-Projects (cont’d)
   eDCI message (electronic Data Capture Instrument)
     • A DCI is a set of related questions for which values are to be collected
       during a clinical trial visit.
     • This model will be used as an HL7 message definition (or a set of
       definitions) that can be used to transmit a DCI Definition between
       databases managed by clinical data management systems (CDMS).
     • Participation from NCI, CDISC, Oracle
     • UML model on bridgproject site -- https://www.bridgproject.org/edci/

     • Current Status –
          •   Requirements have been defined for 1st iteration
          •   UML class diagram is completed
          •   Plans to harmonize with BRIDG
          •   Working on building the message specification (RMIM)
          •   POC – Don Kacher, Oracle
cd DCI Definition, v1.5.2

   Name:       DCI Definition, v1.5.2
   Author:     Don Kacher
                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Guidance on rendering the DCI as a


                                                  eDCI UML class Diagram
   Version:    1.0
                                                                                                                                                                                                                                                                                                                                                                                                                                                                     form. This information is of three sorts:
   Created:    6/7/2005 12:05:46 PM
                                                                                                                                                                                                                                                                                                                                                                                                                                                                     1. Logical behavior: TriggerAction
   Updated:    11/2/2005 5:47:04 PM
                                                                                                                                                                                                                                                                                                                                                                                                                                                                     conveys business rules for interactions
                                                                                                                                                                                                                                                                                                                                                                                                                                 «rendering»                         among fields
                                                                                                                                                                                «structure»
                                                                                                                                                                                                                                                                                                                                                                                                                               DciPresentation                       2. Appearance of elements on the form
                                                                                                                                                                               DciDefinition
                                                                                                                                                                                                                                                                                                                                                                                                                                                                     3. Postion of elements on the form.
                                                                                                                                                                                                                                                                                                                                                                                                  sizes "page"
                                                                                                                                                                                                                                                                                                                                                                                                                        + IntendedFormHeight:                        All three are optional. However, if
      +   MetadataRegistryDCIId:
                                                                                                                                                                                                                                                                                                                                                                                                                        + IntendedFormWidth:                         position is sent, appearance should be
      +   MetadataRegistryDCIVersion:                                                                                                                                                                                                                                                                                                                                                                            0..1
      +
      +
          MetadataRegistryLayoutId:
          MetadataRegistryRAI:
                                                                                                                                                                                                                                                 DCI                                                                                                                                                                                                                 sent as well.


      +
      +
          Name:
          IsTemplateDciFlag:
                                                                                                                                                                                                                                              Definition                                                                                                                                                                DCI-wide default appearance setting
      +   CreationTimestamp:
      +   eDciStandardVersion:                                                                                                                                                                                                                (aka CRF)
      +   ClinicalArea: [0..1]
      +   ClinicalStudy: [0..1]                                                                                                                                                                                                                                                                                                                                                        «rendering»                            «rendering»
      +   HelpText: [0..1]                                                                                                                                                                                                                                                                                                                                                    0..* PersistentInformation                      Instruction
      +   DciDescription: [0..1]
      +   LayoutDescription: [0..1]                                                                                                                                                                                                                                                                                                                                               +   AssociatedElement:                 +   InstructionText:
                                                                                                                                                                                                                                                                                                                                                                                  +   Page: [0..1]                       +   TypeFace: [0..1]
                                                                                                                                                                                                                                                                                                                                                                                  +   ULX: [0..1]                        +   TypeSize: [0..1]                                                                                  0..2
                                                                                                                                                                                            1..*                                                                                                                                                                                  +   ULY: [0..1]                        +   TypeStyle: [0..1]                                                                                                             «rendering»
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              «rendering»               FieldAppearance
                                                                                                                                                                                                                                                                                                                                            1..*                                  +   LRY: [0..1]
                                                          1..*                                                                                                                   «semantic content»                                                                                                                                                                                                                                                                                                                        ItemAppearance
                                                                                                              1..*                                                                                                                                                                                                                                                                +   LRX: [0..1]
                                                                                                                                                                                    SectionDef                                                                      «structure»                                                                                                                                                                                                                                                                  +     FieldTypeFace:
                                                                                                                                                                                                                                                                                                                               «semantic content»                                                                                «rendering»
                                                 «semantic content»                                                                                                                                                                                                 SectionRef                                                                                                                                                                                                                                   +       PromptOrientation:      +     FieldTypesize:
                                                    ValueDomain                                     «semantic content»                                                                                                                                                                                                            ContextItem                                                                                   GraphicImage                                                                     +       PromptTypeFace:
                                                                                                                                                                     + Id:                                                                                                                                                                                                                                                                                                                                                                       +     FieldTypeStyle:
                                                                                                   DataElementConcept                                                                                                          reference
                                                                                                                                                                     + Name:                                                                         +    Id:                                                                                                                                                                                                                                                    +       PromptTypeSize:         +     FieldEnclosure:
                                                                                                                                                                                                                                                                                                                  + DataElementConceptId:                                                                                + Source:
                                   +   Id:                                                                                                                                                                                                      1..* +    Name:                                                                                                                                                                                                                                                  +       PromptTypeStyle:
                                                                                       +   Id:                                                                       + ROASId: [0..1]
                                   +   Name:                                                                                                                                                                                                         +    NavigationSequenceNumber:
                                                                                       +   Definition:                                                                                                                                                                                                  0..*
                                   +   Datatype:                                                                                                                                                                                                     +    EncloseSectionRefInBoxFlag: [0..1]
                                   +   Description: [0..1]                             +   Name:
                                                                                                                                                                                                                                                     +    DifferentiatorQuestionValue: [0..1]
                                   +   DecimalPlaces: [0..1]                           +   ObjectClassDefinition:                                                                                                                                                                                                                                                                                                                                                                                                                                            «rendering»
                                                                                                                                                                                                                                                     +    HelpText: [0..1]
                                   +   MaximumLength: [0..1]                           +   PropertyDefinition: [0..1]                                                                                                                                                                                                                                                                                                                                                                                                                                   RadioButtonAppearance
                                                                                                                                                                                                1..*                                                 +    DifferentiatorQuestion: [0..1]
                                   +   ROASId: [0..1]                                  +   SASDesignatedName: [0..1]                            Definitions of                                                                                                                                                                                      DCI fields, in grouping
                                                                                       +   ROASId: [0..1]                                                                                                                                                                                                                                                                                                                                                                                                                                        +     ButtonLabelTypeFace:
                                   +   SasFormatName: [0..1]                                                                                    DCI component                      «semantic content»                                                                                                                                               structures
                                                                                                                                                base objects.                                                                                                                                                                                                                                          «rendering»                                                                                                                               +     ButtonLabelTypeSize:
                                                                                                                                                                                       GroupDef                                                                                                                                                                                                                                                   Item-specific appearance setting
                                                                                                                                                                                                                                                                                                                                                                                                ItemInstantiationOnAForm                                                                                                                         +     ButtonLabelTypeStyle:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         0..1                                    +     ButtonEnclosureStyle:
                                                                                                                                                                      +   Id:                                                                                       «structure»
                                                                                                                                                                                                                                                                                                                                                                                             + ValueEditWidgetType:                                                                                                                              +     SymbolWhenSet:
                                                                                                                                                                      +   Name:                                                                                      GroupRef
    Global Metadata for
                                                                                                                                                                      +   RepeatingGroupFlag:
    the eDCI                                                                                                                                                                                                                   reference             +    Id:
                                                                                                                                                                      +   ROASId: [0..1]
                                                                                                                                                                      +   DataPersistenceEntityName: [0..1]                                     1..* +    SectionRefId:
                                                                                                                                                                                                                                                     +    SequenceNumber:
                                      «semantic content»                                                                                                                                                                                             +    Name: [0..1]
                                                                        «semantic content»
                                   EnumeratedValueDomain                                                                                                                                                                                             +    NavigateByItemInRepeatFlag: [0..1]
                                                                    NonEnumeratedValueDomain                                                                                                                                                                                                                                                                                                                                                                                                                                  «rendering»
                                                                                                                                                                                                                                                     +    MaximumItemRefRepeats: [0..1]
                              +     VocabularyName:                                                                                      1..*                                                                                                                                                                                                                                                                                                                            «rendering»                                         ValueEditField
                                                                                                                                                                                            1..*                                                     +    HelpText: [0..1]                                                                                                                                                                                             ValueEditWidget
                              +     VocabularyOID: [0..1]
                                                                                                                                                                                                                                                     +    EncloseGroupRefInBoxFlag: [0..1]                                                                                                                                                                                                                           +     FieldPage:
                              +     VocabularyVersion: [0..1]                                                  «semantic content»
                                                                                                                                                                                «semantic content»                                                                                                                                                                                                                                                                                                                   +     FieldULX:
                              +     VocabularyCodeset: [0..1]                                               RegistryObjectAttributeSet                                                                                                                                                                                                                                                0..1
                                                                                                                                                                                     ItemDef                                                                                                                                                                                                                                                                                                                         +     FieldULY:
                                                                                                  +   Id:                                                                                                                                                                                                                                                                                                                                                     0..1                                                   +     FieldHeight:
                                                                                                                                                                 +    Id:                                                                                                                                               «semantic content»                                                                                                                                                                                                                        «rendering»
                                                                                                  +   RegistryAuthorityId: [0..1]                                                                                                                                  «semantic content»                                                                                                                                                                                                                                +     FieldWidth:
                                                                                                                                                                 +    Name:                                                                                                                                          ExplicitItemRefRepetition                                                                                                                                                                                                              RadioButtonPresentation
                                                                                                  +   ObjectId: [0..1]                                                                                                                                                 ItemRef                                                                                                        0..1
                                                                                                                                                                 +    DataElementConceptId:
                                                                                                  +   ObjectVersion: [0..1]                                                                                                   reference                                                                                                                                                                                                                                                                                                            +    EVDSubsetElementRecordSN:
                                                0..*                                                                                                             +    ValueDomainId:                                                                                                                        + RepeatSequenceNumber:                                                                                                                                                                                       «rendering»
                                                                                                                                                                                                                                                      +   Id:                                                                                                                                                                                                                                                                                      +    ButtonPage:
                                                                                                                                                                 +    ROASId: [0..1]                                                             1..* +                                                     + RepeatSpecificDefaultValue: [0..1]                                                                                                                                                                         RadioButtonSet
                                                                                                                                                                                                                                                          ContainerType: [0..1]                                                                                                                                                                                                                                                                    +    LabelULX:
                                   «semantic content»                                                                                                            +    Definition: [0..1]
                                                                                                                                                                                                                                                      +   ContainerId:                               0..*                                                                                                                                                                                                                                          +    LabelULY:
                              EnumeratedValueDomainSubset                                                                                                        +    Comment: [0..1]
                                                                                                                                                                                                                                                      +   HelpText: [0..1]                                                                                                                                                                                                                                                                    1..* +    ButtonULX:
                                                                                                                                                                 +    IsMandatoryFlag: [0..1]
                              + SubsetNumber:                                                                                                                                                                                                         +   NavigationSequenceNumber:                                                                                                                                                                                                                                                                +    ButtonULY:
                              + IsBaseSubsetFlag:                                                                                                                                                                                                     +   IsContextItemFlag:                                                                                                                                                                                                                                                                       +    ButtonLRX:
                                                                                                                                                                                                                                                      +   PromptText:                                                                                                                                                                                                                                                                              +    ButtonLRY:
                                                                                                                                                                                                                                                      +   EnumeratedValueDomainSubsetId: [0..1]
                                                                                                                                                                                ItemDef-wide specification                                                                                                            for a specific explicit rep
                                                                                                                                                                                                                                                      +   IsMandatoryFlag: [0..1]                                                                                                                                                                                               0..1
                                                1..*                                                                                                                                            0..*                 ItemRef-specific specification +     ROASId: [0..1]                                                            0..*
                                                                                                                                                                                                                                                                                                                                                                                                                                                                      «rendering»
                                     «semantic content»                                                                                                                                 «logical behavior»                                                                                                                  «logical behavior»                                                                                                                  PromptRenderingLocation
                                  EVDSubsetElementRecord                                                                                                                                   RangeCheck                                                                                                                        TriggeredAction
                                                                                                                                                       «logical behavior»                                                                                                                                                                                                                                                                                       + Page:
                                                                                                                                                          CheckValue                                                                                               for a ref and any repetitions        +      Action:
                          +       Value:                                                                                                                                   +            Id:                                                                                                                                                                                                                                                                     + PromptULX:
                          +       SequenceNumber:                                                                                                                          +            Comparator:                                                                                                     +      TargetId:                                                                                                                                        + PromptULY:
                                                                                                                                                        + CheckValue:                                         0..*
                          +       ValueMeaning: [0..1]                                                                                                                1..* +            SoftHard:                                                                                                       +      CriterionValue:
                          +       ValueMeaningDescription: [0..1]                                                                                                          +            ErrorMessage: [0..1]                                                                                       0..* +      TriggerRelationship:
                          +       RadioButtonLabel: [0..1]                                                                                                                 +            UnitOfMeasure: [0..1]                                                                                           +      ForcedValue: [0..1]
                          +       HelpText: [0..1]                                                                                                                                                                                                                                                      +      EnumeratedValueDomainSubsetId: [0..1]
BRIDG Sub-Projects (cont’d)


  • Protocol Representation

     • Integral part of the BRIDG model
     • Initial requirements based on CDISC developed list of
       elements
     • This list of elements were “vetted” by CDISC constituents
       and represent their international community
     • It is based on ICH E6 and has a Document view of the
       Protocol
     – Current Status –
             – Work in progress – integrating back into the new BRIDG
               organization
cd Comprehensiv e Logical Model




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Design Concepts::Masking

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +       level:                                   Protocol




                                                                                                                                                                                                                                                                                                                                                                        Clinical Trial Design
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +       objectOfMasking (set):                  Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +       procedureToBreak:                         Control
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +       unmaskTriggerEvent (set):


                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  HasSubElements
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          AbstractActivity
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  «Period»
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Design Concepts::Element

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    -    Children: Set
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Protocol Concepts::DesignCharacteristic                          Protocol                                                                                                                                                                                                -    epochType: EpochTypes

   Name:                   Comprehensive Logical Model                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 +     synopsis:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Configuration
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Protocol                     +     type: test value domain = a,d,f,g
   Author:                 Fridsma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Concepts::                    +     summaryDescription:                                                                                                                                                                                                                   AbstractActivity                                                  hasScheduledEvents                                                              hasElements
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Scope




                                                                                                                                  Protocol Authoring
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +     summaryCode:                                                                                                                                                                                           Design Concepts::PlannedTask
   Version:                1.0                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +     detailedMethodDescription:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              -     displayName: char[]
   Created:                7/22/2005 2:53:51 PM                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        +     detailedMethodCode:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Protocol                                                                                                                           -     whoPerforms: int
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              -     sequence: int
   Updated:                7/29/2005 2:33:32 PM                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Concepts::Bias
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              -     procDefID: PSMCodedConcept
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              -     sourceText: char[]                                                                                                                SubjectEvent
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Design Concepts::Arm
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Protocol Concepts::StudyBackground(w hy)                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Design Concepts::ProtocolEv ent
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -    nameOfArm: char[]
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    description: PSMDescription                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -   parent: AbstractActivity
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    hasElements                                                                                          -    plannedEnrollmentPerArm: char[]
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    summaryOfPreviousFindings: PSMDescription                                                                                                                                                                                                                                                                                                                                                                                                                                                                           -   eventType: ScheduledEventType                                                  -    randomizationWeightForArn: int
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    summaryOfRisksAndBenefits: PSMDescription




                                                                                                                                  and Documentation
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Protocol Concepts::StudyObligation                                                                                                                                                                                                                                                                                                                                                                                                              -   studyOffset: PSMInterval
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               1                                                                                                                                                                         -    associatedSchedules: Set
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    justificationOfObjectives: PSMDescription                                                                                                                                                                                                                                                                                                                                                                                                                                                                           -   studyDayOrTime: char
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    justificationOfApproach: PSMDescription                            +   type: ENUMERATED
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    populationDescription: PSMDescription                              +   description: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    rationaleForEndpoints: PSMDescription                              +   commissioningParty:                                                                                                    Design Concepts::                                Protocol Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    rationaleForDesign: PSMDescription                                 +   responsibleParty:                                                                                                       Randomization                                                                                                                                                                                                        taskAtEvent                               tasksPerformedThisSchedule
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Concurrency
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    rationaleForMasking: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +       minimumBlockSize:                                                                                                                                                                                                                                                                                            hasOngoingEvents
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    rationaleForControl: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    rationaleForAnalysisApproach: PSMDescription                                                                                                                                              +       maximumBlockSize:


                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               1..*

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        AbstractActivity
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          +correlativeStudy 0..*                                                                                                                                                                                                                                                                            Design Concepts::Ev entTask                                                                                                                                                hasArms
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Design Concepts::StudySchedule
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               BusinessObj ects::Study
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 -   localFacilityType: LocalFacilityType                                                       -       Periods: Set
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +   startDate: Date                                +primaryStudy 1
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 -   centralFacilitityType: CentralFacilitiyType                                                -       Tasks: Set
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +   endDate: Date                                                                                                                                                                                                                                                                                                                       -   eventID: OID                                                                                                                                       hasUnscheduledEvents
                                                                                                                                                                                                                                                                                                                                                                                                                                            BusinessObj ects::                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  -       TaskVisits: Set                                                                                                      SubjectEvent
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 BusinessObj ects:                       +   type: PSMCodedConcept                                                                                                                                                                                                                                                                                                               -   taskID: OID
                                                                                                                                                                                                                                                                                                                                                                                                                                        ClinicalDev elopmentPlan                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                -       associatedArms: Set                                                               Design Concepts::UnscheduledEv ent
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   :Amendment                            +   phase: PSMCodedConcept                                                                                                                                                                                                                                                                                                              -   purposes: Set
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +   randomizedIndicator: Text                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             -      eventType: UnscheduledEventType
                                                                                                                                                                                                                                                                                                                                                                                              -_DevelopmentPlan      *
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +   SubjectType: PSMCodedConcept                                                                                                                                 BusinessObj ects::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Activ itySchedule (the "how ",
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      "w here", "w hen", "w ho")
                                                                                                                                                                                                                                                                                                                                                                                                           BusinessObj ects::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Protocol Concepts::StudyObj ectiv e(w hat)                                            +    description: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                      IntegratedDev elopmentPlan
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     1                                                           +   description: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 +   intentCode: SET ENUMERATED
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 +   objectiveType: ENUM{Primary,Secondary,Ancillary}                                                                                                                                                                                                       hasPurposes
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 +   id: PSMID
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   «execution mode»                                                                                                                                                           Design Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                           *                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   StudyActiv ityRef
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Scheduled Sub Activities
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   -      activityID: OID
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              0..*

                                                                                                                                                                                                                                                                                                                                                                                                                                                Protocol Concepts::StudyDocument                                                                                                                                  -source              1     1..*




                                                 Clinical Trial
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  objective                                  Protocol Concepts::Outcome
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   effectiveEndDate: DATETIME                                            BusinessObj ects::                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Defined By
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    1..* -    description: BRIDGDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   version:                                                              ProtocolDocument                                                                                                                                                                                                                                             Design Concepts::Ev entTaskPurpose                                                                    BasicTypes::StudyDatum
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -    ranking: OutcomeRank
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   author: SET                                                                                                                                                                                                                                                                       as Measured By
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -    associatedObjective: Set                                                                                 -   isBaseline: boolean                                                                                -    complete: bool
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   effectiveStartDate: DATETIME                                                                                                                                                                                                                                                                                                                                                                                                          -    value: Value
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -    analyticMethods: Set                                                                                     -   purposeType: PurposeType                                                                                                                                                             Defined By
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   ID: SET PSMID                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     AbstractActivity
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -    asMeasuredBy: Set                                                                                        -   associatedOutcome:                                                                                 -    timestamp: timestamp                   isKindOf                                                                                                                                                    «ODM:ItemDef»
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   documentID:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -    outcomeVariable:                                                                                                                                                                                                -    itemOID:                                                                                                                                                                   kindOf                 Design Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   type: ENUMERATED = formal plus non...                               BusinessObj ects::                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             «abstract»
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -    threshold:                                                                                                                                                                                                                                                                                                                                                    Design                                                  PlannedInterv ention
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   description: PSMDescription                                         ClinicalStudyReport
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   title:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   status: PSMStatus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               StudyActivityDef




                                                 Registration
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   confidentialityCode: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                                                                  BasicTypes::AnalysisVariableInst
                                                                                                                                                                                                                                                                                                                                                                                                                                    +   businessProcessMode: PSMBusinessProcessMode                                                                                                                                                                                                                                                                                                                                                   associatedVariable
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            «ODM ItemData»                                             «ODM:ItemData»                         -    roleInAnalysis: RoleInAnalysisTypes                                                                                    kindOfActivityRelation
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Design Concepts::Observ ation                                    Design Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              BusinessObj ects::                                                                                                                                                                                                                                                                                                                                                         SubjectDatum
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -   transactionType:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            CommunicationRecord
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   -   subjectID: int
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  BasicTypes::StudyVariable

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  -    OID: long
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  «ODM:ItemDef»
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  -    Name: char
                                                                                                                                                                                                                                                                                                                                                                                                                                                     BusinessObj ects::                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Design Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  -    unitOfMeasureID: OID
                                                                                                                                                                                                                                                                                                                                                                                                                                                    SupplementalMaterial                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       PlannedObserv ation
                                                                                                                                                                                                                                                                                                                                                                                                                +source 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         -    minValid:
                                                                                                                                                                                                                                                                                                                                                                                           Entities and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           -    maxValid:
                                                                                                                                                                                                                                                                                                                                                                                                                                         +     type:
                                                                                                                                                                                                                                                                                                                                                                                              Roles::                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             -    controlledName: ENUM
                                                                                                                                                                                                                                                                                                                                                                                                                  +target 0..*           +     description: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                         ResearchProgram                                                                                                                                                                                                                                                                                                                                                                                                                                          «ODM ItemData»                          «ODM:ItemData»
                                                                                                                                                                                                                                                                                                                                                                                                                                         +     version:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Design Concepts::                      Design Concepts::
                                                                                                                                                                                                                                                                                                                                                                                         +    type:                                      +     ID: SET PSMID
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               BasicTypes::RIMActiv ityRelationship                                                                                                                                                                                                                                               DiagnosticImage                       TreatmentConfirmed

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +     relationshipCode: PSMCodedConcept
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +     sequenceNumber: NUMBER
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +     pauseCriterion:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +     checkpointCode:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +     splitCode:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +     joinCode:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +     negationIndicator: BOOLEAN
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +     conjunctionCode:
                                                                                                                                                                                                                                                                                                                                                                                                                                 Entities and Roles::
                                                                                                                                                                                                                                                                                                                                                                                                                                         Study                                                                                                                                                                                                                                                 restates Objective
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Statistical Concepts::StatisticalConceptArea                                                                                          Statistical Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       BusinessObj ects::                                                                                                                                                                 StatisticalAnalysisSet
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                -     evaluableSubjectDefinition: char                                           hasAnalysisSets
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           *          *                                                                                                                                                              StatisticalAnalysisPlan
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                -     intentToTreatPopulation: char                                                                                       +     description: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                             1..*                                                                                                                                                                                                                                                                                                                               -     clinicallyMeaningfulDifference: char                                                                                -     scopeType: AnalysisScopeTypes
                               Entities and Roles::Place                                        Entities and Roles::Entity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      -     proceduresForMissingData: char
                           +       gpsText:                                                                                                                                                                                                                                                                                                                                                                                              1                                                                                                                                                                                                                                                                                                                                      -     statSoftware: char
                                                                                  +   instantiationType: ENUM {Placeholder, Actual}                                                                                                   Entities and Roles::Role                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     BasicTypes::ActActRelation
                           -       mobileInd: boolean                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           -     methodForMinimizingBias: char                                                                                                                      hasCriteria
                                                                                  +   id: SET <PSMID>
                           -       addr:                                                                                            1                                                                                   * +                                                                                                                                                                   Entities and Roles::Activ ityRoleRelationship                                                                                                                                                                                                                                                                                                                                     -     subjectReplacementStrategy: char                                                                                                                                                                                                              -   description: BRIDGDescription
                                                                                  +   name: string                                                                                                                            id:
                           -       directionsText:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          hasHypotheses                       -     randAndStratificationProcedures: char                                                                                                                                                                                                         -   relationQualifier: BRIDGCodedConcept
                                                                                  +   code: PSMCodedConcept                                                                                                               +   code: PSMCodedConcept
                                                                                                                                                                                                                                                                                                                                                                                          +    relationshipCode: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    -   mode: PSMBusinessProcessMode
                           -       positionText:                                  +   quantity: int                                                                                                                       +   name:
                                                                                                                                                                                                                                                                                                                                                                                          +    sequenceNumber: NUMBER                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -   effectiveTime: BRIDGInterval
                                                                                  +   description: PSMDescription                                                                                                         +   status:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Statistical Concepts::AnalysisSetCriterion
                                                                                                                                                                                                                                                                                                                                                                                          +    negationIndicator: BOOLEAN                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           +   priorityNumber: NUMBER
                                                                                  +   statusCode: BRIDGStatus                       1                                                                                     +   effectiveStartDate:
                                                                                                                                                                                                                                                                                                                                                                                          +    time: TimingSpecification                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              -           description: char                                                                                 -   negationRule: AbstractRule
                                                                                  +   existenceTime: BRIDGInterval                                                                                                        +   effectiveEndDate:
                                                                                                                                                                                                                                                                                                                                                                                          +    contactMediumCode: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     -           subgroupVariable: StudyDatum                                                                      -   detail: char
                                                                                  +   riskCode: PSMCodedConcept                                                                                                           +   geographicAddress:                             1                                                                                                          * +    targetRoleAwarenessCode: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                                                                               -           sequence: int                                                                                     -   sourceAct: AbstractActivity
                    Entities and Roles::Organization                              +   handlingCode: PSMCodedConcept                                                                                                       +   electronicCommAddr:
                                                                                                                                                                                                                                                                                                                                                                                          +    signatureCode: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       -   destAct: AbstractActivity
                                                                                  +   contactInformation: SET <PSMContactAddr>                                                                                            +   certificate/licenseText:
                                                                                                                                                                                                                                                                                                                                                                                          +    signature: PSMDescription                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            -   sequence: int
                   +   geographicAddress:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Statistical Concepts::HypothesisTest
                                                                                                                                                                                                                                                                                                                                                                                          +    slotReservationIndicator: BOOLEAN
                   +   electronicCommAddr:
                                                                                                                                                                                                                                                                                                                                                                                          +    substitionConditionCode: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +   «property» relationQualifier() : PSMCodedConcept
                   +   standardIndustryClassCode:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               +   significanceLevel: double
                                                                                                                                                                                                                                                                                                                                                                                          +    id: PSMID                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +   «property» sourceAct() : AbstractActivity
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                +   lowerRejectionRegion: int
                                                                                                                                                                                                                                                                                                                                                                                          +    status: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                                        hasAnalysisSets
                                                                                                                                                                                                                                                 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              +   upperRejectionRegion: int                                                                                                                                                                                                                                                       +   «property» destAct() : AbstractActivity
                                                                                                                                                                                                                                                                                                                                                                                                                                                           1..*                                                                                                                                                                                                                                                                                 +   testStatistic:                                                       hasAnalyses
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Statistical Concepts::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                +   comparisonType: AnalyticComparisonTypes
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       SampleSizeCalculation
                                                                        Entities and Roles::Liv ingEntity                 Entities and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          #   associatedSummaryVariables:
                                                                                                                         Roles::Material                                                                                                                                                                           Entities and Roles::Employee                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           +       clinicalJustification: TEXT
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 -source
                                                                       +   birthTime:
                                                                                                                                                                                                                                                                                                            +      jobCode: PSMCodedConcept                                                                                                                                                                                                      activity
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 +target activity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             kindOfActRelation
                                                                       +   sex:                                          +   formCode:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                           -source
                                                                       +   deceasedInd: boolean                                                                                                                                                                                                                                                                                                                                                                            activity                                                                AbstractActivity
                                                                       +   deceasedTime:                                                                                                                                                                                                                                                                                                                                                                                                  1                                                                                                                                                                                                                                                                                                             kindOfAnalysis
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  BasicTypes::RIMActivity
                                                                       -   multipleBirthInd: boolean                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             kindOfAnalysis
                                                                       -   multipleBirthOrderNumber: int                                                                                                                                                                                                                                                                                                                                                                                      +      businessProcessMode: PSMBusinessProcessMode                                                                                                                                                                                                                                                        -_StatisticalAnalysisSet      *
                                                                       -   organDonorInd: boolean                                                                                                                                                                                                                                                                                                                                                                                             +      code: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                         Statistical Concepts::
                                                                                                                                                                                                                                                                                            Entities and Roles::Patient
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Statistical Concepts::Hypothesis                                                                                                                                                                            StatisticalAssumption                                                                                        BasicTypes::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              +      derivationExpression: TEXT
                                                                                                                                                                                                                                                                                            +   confidentialityCode:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            AbstractRule
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              +      status: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                  AbstractActivity                                                            +     description: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    +TerminatingActivity 1..*                                                                                                                                                    +   statement: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              +      availabilityTime: TimingSpecification                                                                                                                                                                                                                                               -_Hypothesis                                                                                                                                                                                                                                                     -     isExclusive: bool
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 -   associatedObjective:                                                                       Statistical Concepts::Analysis
                                                                                                                  Entities and Roles::          OProtocolStructure::                                                                                                                                                                                                                                                                                                                          +      priorityCode: PSMCodedConcept
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       *                                                                                         -   clinicallySignificantDiff: char                     *
                                                                                                                 ManufacturedMaterial            ElectronicSystem                                                                                                                                                                                                                                                                                                                             +      confidentialityCode: PSMCodedConcept                                                                                                                                                                                                                                                                     +    description: PSMDescription                                                                                                                                                                                                            +     run() : bool
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              +      repeatNumber: rangeOfIntegers               +EndEvent 1                                                                                                                                                                                                                                                  +    analysisType: Set{AnalysisTypes}
                                                                                                             -     lotNumberText: string                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Protocol Concepts::StudyObj ectiv eRelationship                                                                                                                                                                                                                                                                     hasAssumptions
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              +      interruptibleIndicator: BOOLEAN                                                                                                                                                                                                                                                      hasAnalyses         +    analysisRole:
                                                                                                             -     expirationTime:                                                                                                                                                                                                                                                                                                                                                            +      uncertaintyCode: CodedConcept                                                                                                                                                                                                                                                                            +    rationaleForAnalysisApproach: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   +StartEvent 1                                                               +    type: PSMCodedConcept
                                                                                                             -     stabilityTime:                                                                                                                                                                                                                                                                                                                                                             +      reasonCode: PSMCodedConcept                                                                                                                                                                                                                                                                              #    associatedStrategy:
                                                                                                                                                                                                                                                                                  Entities and Roles::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              #    associatedHypotheses:                                                    hasModel                              Statistical Concepts::StatisticalModel
                                                                                                                                                                                                                                                                                         Access
                           Entities and Roles::Person
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    +FirstActivity 1..*
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      +           description: PSMDescription                                                                                implements          Implements           implements
                       +        geographicAddress:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             hasChildAnalyses                                                                                                         #           outputStatistic: StudyVariable
                       -        maritalStatusCode:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      -           computations: Set
                       -        educationLevelCode:
                                                                    Entities and Roles::                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  hasStrategy                                                                 -           assumptions: Set
                       +        raceCode:
                       -        disabilityCode:                    NonPersonLiv ingEntity
                       -        livingArrangementCdoe:
                                                                   +   strain:
                       +        electronicCommAddr:
                                                                   -   genderStatusCode:                          Entities and Roles::Dev ice                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  hasComputations
                       -        religiousAffiliationCode:
                       +        ethnicGroupCode:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             *                                                                                                                                                                                                                                                     Statistical Concepts::                                                                                                                                                             «implementationClass»            «implementationClass»                       «implementationClass»
                                                                                                         -       manufacturerModelName:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Design Concepts::                BusinessObj ects::                          Design Concepts::
                                                                                                         -       softwareName:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   SequentialAnalysisStrategy
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          TemporalRule                     BusinessRule                               ClinicalDecision
                                                                                                         -       localRemoteControlStateCode:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   AbstractActivity
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +      alphaSpendingFunction:
                                                                                                         -       alertLevelCode:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Statistical Concepts::Computation
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +      timingFunction:
                                                                                                         -       lastCalibrationTime:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +      analysis:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      -           description: PSMDescription
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +      trialAdjustmentRule:
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   +IsContainedIn               +sourceActivity 1
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         1..* +targetActivity                                                                                                                                                                                                                                                                                                                                                                                         -           algorithm: char
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      -           input: AbstractStatisticalParameter
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      -           output: AbstractStatisticalParameter




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +contains 1                +generates 0..*
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +passedTo

                                                                                                                                                                                                                                                                                                                                                                                                                                                                    OProtocolStructure::                             OProtocolStructure::                                                                                                                                                                                                                                                                                                                                                                                                                           hasSchedules
                                                                                                                                                                                                                                                                                                                                                                                                                                                                  ResponsibilityAssignment                           Activ ityDeriv edData
                                                                                                                                                                                                                                                                                                                                                                                                                                                       1




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Plans::Protocol/Plan                                               BusinessObj ects::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        SiteSubj ectManagementProj ectPlan




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              1..*

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          1

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  BusinessObj ects::




                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Protocol activities and
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          SiteStudyManagementProj ectPlan

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           BusinessObj ects::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   SponsorStudyManagementProj ectPlan
                                                                                                  BasicTypes::BRIDGInterv al                                         OStudy Design and Data Collection::
                                                                                                                                                                                                                                                                                       BusinessObj ects:
                           BasicTypes::BRIDGBusinessProcessMode                                                                                                        OBRIDGDeriv ationExpression
                                                                                        -   startTime: timestamp                                                                                                                                                                               :
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             1 1..*
                                                                                        +   endTime: timestamp                                             +     type: ENUM{transformation, selection}                                                                                 RegulatoryRecord
                       +       modeValue: ENUM {Plan, Execute}
                                                                                                                                                           +     rule: TEXT
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              BusinessObj ects::Inv estigatorRecruitmentPlan
                                                                                                                                                           +     id: PSMID




                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Safety monitoring (AE)
                                                                                                                                                           +     name: TEXT
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     BusinessObj ects::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 ClinicalTrialMaterialPlans


                                                                                                                                                                                                                                                                    BusinessObj ects::
                                                                                                                                                                OStudy Design and Data Collection::OBRIDGTransition                                              RandomizationAssignment                  BusinessObj ects::               BusinessObj ects::Guide                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         BusinessObj ects::
                                                                                                     BasicTypes::BRIDGID                                                                                                                                                                                  EnrollmentRecord                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            DataMonitoringCommitteePlan
                                                                                                                                                            +    criterion: RULE                                                                                 +    randomizationCode:
                                                                                            +   source: Text                                                +    eventName: TEXT                                                                                 +    subjectID:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 BusinessObj ects::BiospecimenPlan
                                                                                            +   version: Text                                                                                                                                                    +    assignmentDateTime:
                                                                                            +   value: Text



                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      BusinessObj ects::
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     DataManagementPlan
                                                                                                                                                                                    BasicTypes::BRIDGAnalysisVariable                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            BusinessObj ects::AssayProcedures
                                                                                                BasicTypes::BRIDGCodedConcept
                                                                                                                                                           +     name: TEXT
                                                                                            -   code: TEXT                                                                                                                                                              BusinessObj ects::
                                                                                                                                                           +     value:
                                                                                            -   codeSystem:                                                                                                                                                       FinalRandomizationAssignment
                                                                                                                                                           +     controlledName: PSMCodedConcept
                                                                                            -   codeSystemName: TEXT                                       +     businessProcessMode: PSMBusinessProcessMode                                                                                                                      BusinessObj ects::




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Structured
                                                                                            -   codeSystemVersion: NUMBER                                                                                                                                                                                                              Waiv er
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  BusinessObj ects::
                                                                                            -   displayName: TEXT
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Adv erseEv entPlan
                                                                                            -   originalText: TEXT                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     BusinessObj ects::
                                                                                            -   translation: SET{PSMCodedConcept}                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       ContingencyPlan
                                                                                                                                                                                                                                      Protocol Concepts::Constraint
                                                                                                                                                                                                                                                                                                                OStudy Design and Data Collection::




                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Eligibility
                                                                                                                                                                                                                                                                                                                  OEncounterDefinitionList--???

                                         BasicTypes::BRIDGStatus                                                                                                            BasicTypes::BRIDGContactAddr                                                                                                     +     listOfDataCollectionInstruments:
                                                                                «abstraction»                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        BusinessObj ects::
                               +     effectiveEndDate:                                                                                                     +     type: PSMCodedConcept                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Subj ectRecruitmentPlan
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                BusinessObj ects::SafetyMonitoringPlan




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Statistical Analysis
                                                                                                                                                                                                                                                                                                                                                                  Protocol Concepts::
                               +     effectiveStartDate:                                                                                                   +     effectiveTime: BRIDGInterval
                                                                                                                                                                                                                                                                                                                                                                       Variance
                               +     statusValue:                                                                                                          +     usage: PSMCodedConcept                                                                               Protocol Concepts::
                                                                                                                                                                                                                              Protocol Concepts::
                                                                                                                                                                                                                               EligibilityCriterion                   ExclusionCriterion




                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Determination
                                                                                                                                                                                                                                                                                                     BusinessObj ects:
                                                                                                                                                                                                                                                                                                     :ProtocolRev iew
                                                                                                                                                                                                                                                                                                                                            Protocol Concepts::
                                                                                                                                                                                                                                                                                                     +   date:                                   Milestone
                                                                                                                                                                                                                                                                                                     +   result:
BRIDG development

     Top-Down scaffolding Development




               BRIDG

   Use case driven, subproject Development
Current Status


• URL for the BRIDG project
   – www.BRIDGproject.org
• Active participation from CDISC, pharmaceutical
  companies (GSK, Lilly, others), and industry
  (Fasttrack, ScenPro, Oracle), caBIG (COH, UPMC,
  MSKCC, and others)
   – Committing real resources and time to the effort
   – A true collaboration with the various stakeholders in the
     effort
• Face-to-Face caBIG meeting
   – April 9th-11th in Crystal City, VA
Cumulative Registered Users
Organization of BRIDG


• BRIDG Advisory Board
   – Representation from the current key stakeholders in the
     model
       • CDISC, NCI, HL7
       • Representation from PhARMA
   – Provides strategic guidance for priorities and collaboration
• BRIDG technical harmonization group
   – Responsible for the “mechanics” of model maintenance and
     harmonization
• Multiple subprojects
   – Use some of the shared resources, but primarily volunteer
Establishing a comprehensive educational
program around BRIDG

• Targeting various learners
   – Domain experts
        • How do you contribute your expertise into the model?
        • Storyboards, use cases
   – Modeling experts
        • How do you take the storyboards and use cases and construct formal
          models of the expertise?
            – Modeling best practice
   – Technical experts
        • How do you take these formal models of expertise and create
          applications that address these problems?
• Various ways to learn
   –   HL7 tutorial in January 2006
   –   Webinar in February and March 2006
   –   CDISC/HL7 joint meeting in Berlin, April 2006
   –   Bootcamp for deep understanding of the model (?March)
Ways to participate


• HTML view of the model
    – www.bridgproject.org/model
    – Updated ever 10-14 days – represents the current active model
• Trackers
    – Modeled after HL7 Harmonization forms
    – Useful for smaller comments, definitions, suggestions
• Download the model from the CVS repository or file release
    – file release
    – CVS repository
• Active model development in subprojects

• It is likely that there are a range of individuals within a particular
  organization that can contribute – domain experts, modeling
  experts, and technical experts
  What does it mean to “adopt BRIDG” or
  “harmonize with BRIDG?”

• Adopting and harmonizing with BRIDG is a two-way street
   – The model is not complete, and harmonization and adoption
     requires participation and contribution to BRIDG from others
   – The model is new and is changing, so harmonization and adoption
     requires flexibility and change
• Early adopters will have a more significant impact on the
  direction and development of BRIDG
• Adopting and harmonization with BRIDG is less about a
  commitment to a specific model, but the realization that
   – A common standard is a shared good that all can benefit from
   – It will require contribution and collaboration as we collectively
     determine the best approaches
   – It will require compromise and collective action
  Final thoughts: our approach to modeling

• Scope – keep it clear and focused (ie, solve a problem that exists)
  and standardize to the extend needed
    – Refine through experience, and not endless discussions. This keeps the
      modeling effort clear and focused
    – BRIDG is not complete – but the scaffolding is there to help organize
      the analysis and model development in subprojects
• Keep it generic, faithful, free of implementation specific formalisms,
  and supporting the requirements
• If the tools and models don’t work with reality – it is probably the
  tools and the models that need to change
• If it’s broke, fix it
    – The model is in evolution with known problems – the problems should
      be an opportunities for improvement and a call to arms, not barriers to
      use
• Model in the open
• Collaborate until it hurts

                   With thanks to Dipak Kalra for discussion
    Fridsma@cbmi.pitt.edu
       caBIG.nci.nih.gov
https://www.BRIDGproject.org
     BioPharma R&D Conundrum
         R&D                  Investigational        New Chemical
     Expenditures                New Drug               Entities
         ($B)                  Applications            Approved
      1986-2004                 1986-2004              1986-2004
35                      600                     60
30                      500                     50
25                      400                     40
20
                        300                     30
15
                        200                     20
10
5                       100                     10

0                        0                      0
1986   91   96   2001    1986   91   96 2001    1986 91   96 2001
Clinic Research back office… after the
paper is gone



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