Org Roll Up Proposal NIH by alicejenny

VIEWS: 3 PAGES: 43

									      CTRP
Organization Roll-Up
     Proposal


  December 7th, 2010
Agenda

• Business Problem
• Organizational Roll-Up Proposed Solution and
  Business Rules
• Proposed Model changes
• Example Relationships
• Organization Relationship in COPPA/ BRIDG models
• Example Screen Mockups
• Next Steps
Business Problem

• Ability to group related organizations together
• Ability to create Summary 4 Reports for NCI designated
  cancer centers
• Allow for trials to queried/reported by organizational
  groups
• Capture organizational relationships
• Allow for organizational hierarchy
Business Problem - Example

 Mayo Clinic Comprehensive Cancer Center is a virtual
 entity comprised of components of several of the Mayo
 Clinic’s and hospitals. While most of the entities share
 the Mayo name, each are separate entities that share a
 common mission.
                                                                                 Mayo Clinic




                                                                                           Mayo Clinic




                                                                                                                                                              Mayo Phase 2       Mayo Clinic Cancer
    Mayo Clinic                                 Mayo Clinic                                                                                                    Consortium       Research Consortium
                     Mayo Clinic Hospital                          Mayo Hospital      Mayo Clinic Rochester   Saint Mary’s Hospital                                                (pending poid
Scottsdale-Phoenix                              Jacksonville                                                                          Rochester Methodist   (ctepid MPC/ poid
                     (ctepid AZ073/poid                          (ctepid 37005/poid    (ctepid MN026/poid      (ctepid MN112/poid                                145720)             7681606)
(ctepid AZ020/poid                          (ctepid FL080/poid                                                                             Hospital
                           33657)                                     262251)                139137)                 141101)
      32332)                                      72120)



                                                                                                              MCMC
                                                                 MCCC




                                                                                                MCCC – Mayo Clinic Cancer Center
                                                                                                MCMC – Mayo Clinic Medical Center
Mayo Clinic - Query

  To find all the studies for Mayo Clinic Cancer Center,
  one would have to manually identify all the organizations
  that would make up Mayo Clinic. Cancer Center. Then
  identify each of the roles it could be playing (RO, HCF,
  IRB). Then create a query to search for the protocols
  where with any of these structured role ids
Solution

• Implement organizational relationships within CTRP to
  allow for organizational entities to be grouped into
  families while not effecting the current relationships
  between organizational entities and their structural roles.

• Also introduce business rules around the organization
  relationships.
Business Rules for Organization Roll Up
(1 of 2)
• Top Level of a Family – Organization Entities with Peer and/or Parent
   and not a child.
• Family Name - All entities take same family name (note:       Participating
   Sites on a study are not members are not necessarily part of an
   organization.)
• Relationship Association Types:
    - Family – Parent, Child, Peer, Subdivision*, Department*
    - Business – Organizational, Contractual Associations, Affiliations
• Application Functionality
    - Query, Browse and Report by Family (allow for Family or Family and
      Business)



*May not be needed
Business Rules for Organization Roll Up
(2 of 2)
• Possible Organizational Access Requirements
   - To be included in functional applications (i.e. REG, PA, …)
   - Trust between entities needs to be approved by each pair of entities
   - Trust by sub division or department is automatic
• Curation would be done by CTRO as part of normal
  Organization Curation procedures
• No changes to current structural roles or relationships
  would be made
• No changes would be make to the relationships between
  Organizations and Protocols (duel ownership not
  addressed organization roll-up)
Proposed Model Changes

• Add Organizational Relationship model (Class)
• Include attributes for:
   - Include Effective Dates*
   - Relationship Type* (Parent, Child, Peer, Subdivision,
     Department)
   - Allow for other Relationship Types (Organizational,
     Contract [contractual associations], Affiliations)
   - Allow for Family Name



   * These attributes are already in BRIDG 3.0.2
Hierarchy and Organization Relationships in
COPPA/BRIDG

• COPPA/BRIDG 2.1 – No Relationships
• BRIDG 2.2 – Organization Part (A subdivision within an
   organization)
• BRIDG 3.0 – Organization Part
• BRIDG 3.0.1- no change from 3.0
• BRIDG 3.0.2 – Organization Relationship (specifying the kind
   of organization relationship.)
                   As the Models are Flexible and
                   Evolving, we should move to


• COPPA – With Organizational Relationships (With some
   attributes from BRIDG 3.0.2)
    Parent Child Relationship


                                   A



                        A1                   A2


Source Name   Target Name    Family Name   Relationship   Relationship Type   Effective Date

A             A1             A             Parent         Organizational      1/1/2000 -

A             A2             A             Parent         Organizational      1/1/2000 -

A1            A              A             Child          Organizational      1/1/2000 -

A2            A              A             Child          Organizational      1/1/2000 -
    Parent Child Grand Child Relationship

                                                A

                             A1                                A2

              A11                       A12
Source Name    Target Name        Family Name   Relationship   Relationship Type   Effective Date

A              A1                 A             Parent         Organizational      1/1/2000 -
A              A2                 A             Parent         Organizational      1/1/2000 -
A1             A                  A             Child          Organizational      1/1/2000 -
A2             A                  A             Child          Organizational      1/1/2000 -
A1             A11                A             Parent         Organizational      1/1/2000 -
A1             A12                A             Parent         Organizational      1/1/2000 -
A11            A1                 A             Child          Organizational      1/1/2000 -
A12            A1                 A             Child          Organizational      1/1/2000 -
Peer Relationship


                   A                      B                     C


        A1                      A2
Source Name   Target Name   Family Name   Relationship   Relationship Type   Effective Date

A             B             D             Peer           Organizational      1/1/2000 -
B             A             D             Peer           Organizational      1/1/2000 -
A             C             D             Peer           Organizational      1/1/2000 -
C             A             D             Peer           Organizational      1/1/2000 -
B             C             D             Peer           Organizational      1/1/2000 -
C             B             D             Peer           Organizational      1/1/2000 -
A             A1            D             Parent         Organizational      1/1/2000 -
A             A2            D             Parent         Organizational      1/1/2000 -
A1            A             D             Child          Organizational      1/1/2000 -
A2            A             D             Child          Organizational      1/1/2000 -
Peer Child with Contract

                    A                      B


         A1                     A2                  A3
Source Name   Target Name   Family Name   Relationship   Relationship Type   Effective Date

A             B             D             Peer           Organizational      1/1/2000 -
B             A             D             Peer           Organizational      1/1/2000 -
A             A1            D             Parent         Organizational      1/1/2000 -
A             A2            D             Parent         Organizational      1/1/2000 -
A             A3            D             Parent         Contract            1/1/2000 -
A1            A             D             Child          Organizational      1/1/2000 -
A2            A             D             Child          Organizational      1/1/2000 -
A3            A             D             Child          Contract            1/1/2000 -
Example Organizations

• Mayo

• Wake Forest

• Duke
                                                                                 Mayo Clinic




                                                                                           Mayo Clinic




                                                                                                                                                              Mayo Phase 2       Mayo Clinic Cancer
    Mayo Clinic                                 Mayo Clinic                                                                                                    Consortium       Research Consortium
                     Mayo Clinic Hospital                          Mayo Hospital      Mayo Clinic Rochester   Saint Mary’s Hospital                                                (pending poid
Scottsdale-Phoenix                              Jacksonville                                                                          Rochester Methodist   (ctepid MPC/ poid
                     (ctepid AZ073/poid                          (ctepid 37005/poid    (ctepid MN026/poid      (ctepid MN112/poid                                145720)             7681606)
(ctepid AZ020/poid                          (ctepid FL080/poid                                                                             Hospital
                           33657)                                     262251)                139137)                 141101)
      32332)                                      72120)



                                                                                                              MCMC
                                                                 MCCC




                                                                                                MCCC – Mayo Clinic Cancer Center
                                                                                                MCMC – Mayo Clinic Medical Center
   Relationship Table for Mayo (example 1)


                                 PO         Org_Name_I Org_Relationship     Other Org         Relationship to    Relationship
         Org_Name                Org-ID         D            _ID        Relationship Type      (po Org-ID)           to ID
Mayo Clinic Scottsdale-Phoenix      32332        1         1 (parent)    1 (Organizational)              33657        2
Mayo Clinic Scottsdale-Phoenix      32332        1          3 (peer)     1 (Organizational)              72120        3
Mayo Clinic Scottsdale-Phoenix      32332        1          3 (peer)     1 (Organizational)             139137        5
     Mayo Clinic Hospital           33657        2          2 (child)    1 (Organizational)              32332        1
   Mayo Clinic Jacksonville         72120        3          3 (peer)     1 (Organizational)              32332        1
   Mayo Clinic Jacksonville         72120        3          3 (peer)     1 (Organizational)             139137        5
    Mayo Clinic Rochester          139137        5         1 (parent)    1 (Organizational)             141101        6
    Mayo Clinic Rochester          139137        5          3 (peer)     1 (Organizational)              32332        1
    Mayo Clinic Rochester          139137        5          3 (peer)     1 (Organizational)              72120        3
    Mayo Clinic Rochester          139137        5         1 (parent)       2 (Contract)                145720        4
    Mayo Clinic Rochester          139137        5         1 (parent)       2 (Contract)               7681606        3
    Mayo Clinic Rochester          139137        5         1 (parent)    1 (Organizational)             262251        5
     Saint Mary’s Hospital         141101        6          2 (child)    1 (Organizational)             139137        5
        Mayo Hospital              262251        4          2 (child)    1 (Organizational)             139137        5
  Mayo Phase 2 Consortium          145720        8          2 (child)       2 (Contract)                139137        5
Mayo Clinic Cancer Research
        Consortium                7681606        9          2 (child)       2 (Contract)                139137        5
                                    Mayo Clinic (example 1)

                           Mayo Clinic Cancer Center
                           (Organization and Contracts)




    Mayo Clinic             Mayo Clinic
Scottsdale-Phoenix          Jacksonville                      Mayo Clinic
                        (ctepid FL080/poid                  Rochester (ctepid
(ctepid AZ020/poid                                         MN026/poid 139137)
      32332)                  72120)



                                                                           Mayo Phase 2      Mayo Clinic Cancer
Mayo Clinic Hospital   Saint Mary’s Hospital     Mayo Hospital
                                                                            Consortium           Research
(ctepid AZ073/poid      (ctepid MN112/poid     (ctepid 37005/poid                            Consortium (pending
                                                                         (ctepid MPC/ poid
      33657)                  141101)               262251)                                    poid 7681606)
                                                                              145720)
     Relationship Table for Mayo (example 2)
                                                                                       Other Org Relationship   Relationship to (
             Org_Name                    PO Org-ID Org_Name_ID   Org_Relationship_ID            Type              po Org-ID)            Relationship to
    Mayo Clinic Scottsdale-Phoenix            32332     1              3 (peer)           1 (Organizational)                    33657          2
    Mayo Clinic Scottsdale-Phoenix            32332     1              3 (peer)           1 (Organizational)                    72120          3
    Mayo Clinic Scottsdale-Phoenix            32332     1              3 (peer)           1 (Organizational)                  262251           4
    Mayo Clinic Scottsdale-Phoenix            32332     1              3 (peer)           1 (Organizational)                  139137           5
    Mayo Clinic Scottsdale-Phoenix            32332     1              3 (peer)           1 (Organizational)                  141101           6
        Mayo Clinic Hospital                  33657     2              3 (peer)           1 (Organizational)                    32332          1
        Mayo Clinic Hospital                  33657     2              3 (peer)           1 (Organizational)                    72120          3
        Mayo Clinic Hospital                  33657     2              3 (peer)           1 (Organizational)                  262251           4
        Mayo Clinic Hospital                  33657     2              3 (peer)           1 (Organizational)                  139137           5
        Mayo Clinic Hospital                  33657     2              3 (peer)           1 (Organizational)                  141101           6
       Mayo Clinic Jacksonville               72120     3              3 (peer)           1 (Organizational)                    32332          1
       Mayo Clinic Jacksonville               72120     3              3 (peer)           1 (Organizational)                    33657          2
       Mayo Clinic Jacksonville               72120     3              3 (peer)           1 (Organizational)                  262251           4
       Mayo Clinic Jacksonville               72120     3              3 (peer)           1 (Organizational)                  139137           5
       Mayo Clinic Jacksonville               72120     3              3 (peer)           1 (Organizational)                  141101           6
            Mayo Hospital                    262251     4              3 (peer)           1 (Organizational)                    32332          1
            Mayo Hospital                    262251     4              3 (peer)           1 (Organizational)                    33657          2
            Mayo Hospital                    262251     4              3 (peer)           1 (Organizational)                    72120          3
            Mayo Hospital                    262251     4              3 (peer)           1 (Organizational)                  139137           5
            Mayo Hospital                    262251     4              3 (peer)           1 (Organizational)                  141101           6
       Mayo Clinic Rochester                 139137     5              3 (peer)           1 (Organizational)                    32332          1
       Mayo Clinic Rochester                 139137     5              3 (peer)           1 (Organizational)                    33657          2
       Mayo Clinic Rochester                 139137     5              3 (peer)           1 (Organizational)                    72120          3
       Mayo Clinic Rochester                 139137     5              3 (peer)           1 (Organizational)                  262251           4
       Mayo Clinic Rochester                 139137     5              3 (peer)           1 (Organizational)                  141101           6
       Mayo Clinic Rochester                 139137     5             1 (Parent)             2 (Contract)                     145720           8
       Mayo Clinic Rochester                 139137     5             1 (Parent)             2 (Contract)                    7681606           9
        Saint Mary’s Hospital                141101     6              3 (peer)           1 (Organizational)                    32332          1
        Saint Mary’s Hospital                141101     6              3 (peer)           1 (Organizational)                    33657          2
        Saint Mary’s Hospital                141101     6              3 (peer)           1 (Organizational)                    72120          3
        Saint Mary’s Hospital                141101     6              3 (peer)           1 (Organizational)                  262251           4
        Saint Mary’s Hospital                141101     6              3 (peer)           1 (Organizational)                  139137           5
      Mayo Phase 2 Consortium                145720     8              2 (child)             2 (Contract)                     139137           5
Mayo Clinic Cancer Research Consortium      7681606     9              2 (child)            2 (Contract)                      139137          5
                                                               Mayo Clinic (example 2)

                                                 Mayo Clinic Cancer Center
                                                 (Organization and Contracts)




                                                                                                                                                   Mayo Phase 2
                                                                                                                                                    Consortium         Mayo Clinic Cancer
Mayo Clinic Scottsdale-                          Mayo Clinic Jacksonville                                                                                             Research Consortium
                          Mayo Clinic Hospital                                Mayo Hospital      Mayo Clinic Rochester   Saint Mary’s Hospital   (ctepid MPC/ poid
       Phoenix                                     (ctepid FL080/poid                                                                                                (pending poid 7681606)
                          (ctepid AZ073/poid                                (ctepid 37005/poid    (ctepid MN026/poid      (ctepid MN112/poid          145720)
  (ctepid AZ020/poid                                     72120)                                         139137)
                                33657)                                           262251)                                        141101)
        32332)
Summary for Mayo Clinic

• Adding relationships allow for organization roll up
• Relationships are flexible.
• Once an organization is included in a relationship (i.e.
  Family) , you can report out in different ways –
  Organizational or Organizational and Contract
• The family roll up will report out all entities weather the
  relationship is with Parents as Peers or all Peers
                                     Wake Forest

                                                                      Wake Forest University
                                                                      Baptist Medical Center




                                             Wake Forest University
Wake Forest University                          Health Sciences
                                                                                                         Hospital
                                              (ctepid NC002/poid
                                                    149074)




                    Wake Forest University
                                                                        Outpatient
                       Cancer Center                                                           Inpatient Departments
                                                                       Departments
                         (CCCWF)
                                             WFCCC


                     Wake Forest Cancer                 Wake Radiology
                    Center Research Base                   Oncology              Wake Medical Center -
                                                                                 Breast Screening and
                    (ctepid RSB003 /poid              (ctepid NC124/poid               Diagnostic
                           213850)                          151934)
                                                                                  (ctepid NC008/poid
                                                                                        149221)               NCBH
                                                 WFUHS
  Coop Affiliates




                                                                      WFCCC - Wake Forest Comprehensive Cancer Center
                                                                      WFUHS - Academic side of the Medical Center
                                                                      NCBH – Hospital side of Medical Center
        Wake Forest Comprehensive
           Cancer Center


                       Wake Forest University
                          Health Sciences
                        (ctepid NC002/poid
                              149074)




                                                Wake Medical Center -
 Wake Forest Cancer       Wake Radiology
                                                Breast Screening and
Center Research Base         Oncology
                                                     Diagnostic
(ctepid RSB003 /poid    (ctepid NC124/poid
                                                 (ctepid NC008/poid
       213850)                151934)
                                                       149221)
     Relationship Table for Wake Forest

                                                                      Other Org                Relationship to
Org_Name                  PO Org-ID   Org_Name_ID Org_Relationship_ID Relationship Type        (po Org-ID)       Relationship to


Wake Forest University
Health Sciences            149074          1             1 (parent)       1 (Organizational)        149221                2


Wake Forest University
Health Sciences            149074          1             1 (parent)       1 (Organizational)        151934                3


Wake Forest University
Health Sciences            149074          1             1 (parent)       1 (Organizational)        213850                4


Wake Medical Center -
Breast Screening and
Diagnostic                 149221          2              2 (child)       1 (Organizational)        149074                1

Wake Radiology Oncology    151934          3              2 (child)       1 (Organizational)        149074                1


Wake Forest Cancer
Center Research Base       213850          4              2 (child)       1 (Organizational)        149074                1
Duke University




DCCC




             DCCC -Duke Comprehensive Cancer Center
Duke University
   Relationship Table for Duke
Org_Name                                   PO Org-ID    Org_Name_ID   Org_Relationship_ID   Other Org Relationship Type     Relationship to (po Org-ID)   Relationship to
      CALGB Statistical Data Center            56231           1                3 (peer)               1 (Organizational)                268200                    3
      CALGB Statistical Data Center            56231           1               2 (child)               1 (Organizational)                149280                    6

   Duke - NUS Graduate Medical School
               Singapore                       268200          2                3 (peer)               1 (Organizational)                 56231                    3

   Duke - NUS Graduate Medical School
               Singapore                       268200          2               2 (child)               1 (Organizational)                149280                    6


 Duke Health Center at North Duke Street       153168          3                3 (peer)               1 (Organizational)                152344                    4


 Duke Health Center at North Duke Street       153168          3                3 (peer)               1 (Organizational)                8654398                   5


 Duke Health Center at North Duke Street       153168          3                3 (peer)               1 (Organizational)                149280                    6

  Duke Hematology Oncology at Raleigh
         Community Hospital                    152344          4                3 (peer)               1 (Organizational)                153168                    3

  Duke Hematology Oncology at Raleigh
         Community Hospital                    152344          4                3 (peer)               1 (Organizational)                8654398                   5

  Duke Hematology Oncology at Raleigh
         Community Hospital                    152344          4                3 (peer)               1 (Organizational)                149280                    6
           Duke Raleigh Hospital              8654398          5                3 (peer)               1 (Organizational)                153168                    3
           Duke Raleigh Hospital              8654398          5                3 (peer)               1 (Organizational)                152344                    4
           Duke Raleigh Hospital              8654398          5                3 (peer)               1 (Organizational)                149280                    6


  Duke University Medical Center (DUMC)        149280          6                3 (peer)               1 (Organizational)                153168                    3


  Duke University Medical Center (DUMC)        149280          6                3 (peer)               1 (Organizational)                152344                    4


  Duke University Medical Center (DUMC)        149280          6                3 (peer)               1 (Organizational)                8654398                   5


  Duke University Medical Center (DUMC)        149280          6               1 (parent)              1 (Organizational)                 56231                    1


  Duke University Medical Center (DUMC)        149280          6               1 (parent)              1 (Organizational)                268200                    2
Hierarchy and Organization Relationships in
COPPA/BRIDG

• COPPA/BRIDG 2.1 – No Relationships
• BRIDG 2.2 – OrganizationPart (A subdivision within an
   organization)
• BRIDG 3.0 – OrganizationPart
• BRIDG 3.0.1- no change from 3.0
• BRIDG 3.0.2 – OrganizationRelationship (specifying the kind of
   organization relationship.)


                   Models are Flexible and Evolving
BRIDG 2.1
BRIDG 2.2
      Mayo Clinic
BRIDG 3.0 / 3.01
  Mayo Clinic
BRIDG 3.0.2
                                                                                                                                                                                                                                                                                            Mayo for CTRP
                                                                                                                                                                                                                                                                                   Proposed ModelClinic 3.4
                                                                                                                                                                                                                                                                              (addition of Organizational Relationship)
class CTRP Information Model

          Name:    CTRP Information Model
          Package: nci.coppa.InformationModel
          Version: 3.2
          Author:  CTRP Team                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Document

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +    activeIndicator: BL                                                         StudyIndIde                                   DocumentWorkflow Status
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +    fileName: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +    identifier: II                                                +   expandedAccessIndicator: BL               +              commentText: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +    inactiveCommentText: ST                                       +   expandedAccessStatusCode: CD              +              identifier: II
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +    text: ED                                                      +   grantorCode: CD                           +              statusCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +    typeCode: CD                                                  +   holderTypeCode: CD                        +              statusDateRange: IVL<TS>
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +    universalResourceLocator: TEL.URL                             +   identifier: II
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          +   indIdeNumber: ST            +workflowStatus              1..*
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          +document       1..*                            +   indIdeTypeCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               StudyRelationship
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          +   nciDivProgHolderCode: CD                                          StudyMilestone
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           0..*
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          +   nihInstholderCode: CD                                                                                   +   commentText: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           +   commentText: ST                        +   descriptionText: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          0..*             +   identifier: II
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          +Particicpant                                                                                                                                               +   sequenceNumber: INT                                                                StudyOutcomeMeasure
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           +   milestoneCode: CD                      +   typeCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          1..*                                                                                                             +   milestoneDate: TS                                                                                                         +    identifier: II
                                                                                                                                                                                                                                                                                                                                                                                                                                                            FunctionalRole
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +    name: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            0..*                             0..*
                                                                                                                                                                                                                                                                                                                                                                                                                                     +   identifier: II                                                                                                                                                                                                                                                                                                  +    primaryIndicator: BL
                                                                                                                                                                                                                                                                                                                                                                                                                                     +   statusCode: CD                                                                                                                                               1                1                1              1    1                                                                                            +    safetyIndicator: BL
                                                                                                                                                                                                                                                                                                                                                                                                                                     +   statusDateRange: IVL<TS>                                                                                                                                                                                                                                                                                        +    timeFrame: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             1                                 StudyProtocol                      1                                                                               0..*
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             StudyResourcing provided by
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       acceptsHealthyVolunteersIndicator: BL                                                                               StudyObj ectiv e
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           1                                                      0..*                                                                                       StudyParticipation.functionCode
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       accrualReportingMethodCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +   name: ST                                                                        = 'Funding Source' or 'Non-
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       acronym: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +   outline: ST                                                                     Monetary Source'
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    StudyDisease                                                  +       amendmentDate: TS
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       amendmentNumberText: ST                                                                                        +   targetAccrualText: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          +      ctGovXmlIndicator: BL                                            +       amendmentReasonCode: CD                                                                                        +   typeCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          +      diseaseCode: CD          0..*                               1    +       assignedIdentifier: II
                                                                                                                                   StructuralRole is played by exactly one                                                                                                                                                                                                                                                                                                                                                +      identifier: II                                                   +       bibliographicDesignation: ST                                                                                                                                                                        StudyResourcing
                                                                                                                                   Person, one Organization, or one Product,                                                                                                                                                                                                                                                                                                                                              +      leadDiseaseIndicator: BL
                                                                                                                                                                                                                                                                                                Functional roles played by an OrganizationRole                                                                                                                                                                                                                                                    +       ctGovXmlRequiredIndicator: BL
                                                                                                                                   but, not more than one, and if scoped, is                                                                                                                                                                                                                                                                                                                                                                                                                                                                               1                                                                                                                             0..* +     activeIndicator: BL
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       dataMonitoringCommitteeAppointedIndicator: BL                                                                                                                                                                                                            organizationI
                                                                                                                                   scoped by an Organization (there are some                                                                                                                    StudyOversightCommittee must be played by a                                                                                                                                                                                              1..*                                                                                                                                                 StratumGroup                                                                                    +     fundingMechanismCode: CD                                       dentifier
                                                                                                                                   OrganizationRoles that may not have                                                                                                                                                                                                                                                                                                                                                                                                                            +       delayedpostingIndicator: BL
                                                                                                                                                                                                                                                                                                OversightCommittee (OrganizationRole)                                                                                                                                                                                                                                                                                                                                                                                                                                                         +     inactiveCommentText: ST                                        needs to be
                                                                                                                                   scoper).                                                                                                                                                                                                                                                                                                                            PersonFunctionalRole                                                                                                       +       expandedAccessIndicator: BL                                       +               description: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              +     nciDivisionProgramCode: CD                                     reviewed in
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +studyProtocolIdentifier   +       FDAregulatedIndicator: BL                                         +               groupNumberText: ST
                                                                                                                                                                                                                                                                                                StudyParticipation could be played by any OrganizationRole                                                                                     ::FunctionalRole                                                                                                                                                                                            1         0..*                                                                                                                     +     nihInstituteCode: CD                                           next release
                                                                                                                                   The link to Participation (blue) and to                                                                                                                                                                                                                                                                                                                                                                                                                        +       keywordText: ST                                                   +               identifier: II
                                                                                                                                                                                                                                                                                                other than OversightCommittee                                                                                                                  + identifier: II                                                                                                                                                                                                                                                                                                                               +     organizationIdentifier: II
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             1    +       maximumTargetAccrualNumber: INT
                                                                                                                                   Study (red) will be from StructuralRole                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    +     serialNumber: INT
                                                                                                                                                                                                                                                                                                                                                                                                                                               + statusCode: CD                                                                                                                                   +       monthlyTargetAccrualNumber: INT
                                                                                                                                                                                                                                                                                                StudyResourceProvider could be played by any OrganizationRole                                                                             0..* + statusDateRange: IVL<TS>                                                                        StudyRecruitmentStatus                                                                                                                                                                                                                       +     summary4ReportedResourceIndicator: BL
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       officialTitle: ST                                                                        StudyOnHold
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           1            0..*                                                                        StudyOv erallStatus                       +     typeCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 +      identifier: II                            +       phaseCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 0..*        1    +       phaseOtherText: ST                                                            +    identifier: II                                                                                                                                                                                                                        Activ ityRelationship
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 +      statusCode: CD                                                                                                                                                                 +     commentText: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       primaryCompletionDate: TS                                                     +    onHoldDate: IVL<TS>
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 +      statusDate: TS                                                                                                                                                                 +     identifier: II                                                                                                                                                         +     typeCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       primaryCompletionDateTypeCode: CD                                             +    onHoldReasonCode: CD
                                                                                                                                                                                                       StructuralRole                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +     statusCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       primaryPurposeCode: CD                                                        +    onHoldReasonText: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +     statusDate: TS
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       primaryPurposeOtherText: ST                                                                                                                                                                                                                                                                                       0..*                               0..*                                                                                  ObservationResult
                                                                                                                                         +   identifier: DSET<II>                                                                                                                                                                                                                                                                                                                                       Subj ect                                                                                                                                                                                                                       +     statusTypeCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  +       programCodeText: ST
                                                                                                                                         +   statusCode: CD                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            +     studyStoppedReasonCode: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           ::FunctionalRole                                                                                       +       proprietaryTrialIndicator: BL                    1                                                                    0..*                                                                                                                                                                                                                                                                                                         +   resultCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           associates to / may be the target
                                                                                                              +scoper                                                                                                                                                                                                                                                                                 Specific OrganizationRoles may fill                                                  + identifier: II                                                                                       +       publicDescription: ST                                                                                                                                                                                                                                   NOTE: brought in .nameCode and name                                                                                                                                        +   resultCodeModifiedText: ST
                                                             +Target                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       for
                                                                                                                                                                                                                                                                                                                                                                                                      OrganizationFunctionalRole (ie., on a                                                + statusCode: CD                                                                                       +       publicTitle: ST                                                                                                                                                                                                                                         PerformedActivity has name (course        associates from / may be the source                                                                                              +   resultDateRange: IVL<TS>
                                                   +Source                        Organization
                                                  {is target for } 1                                          0..1                0..*                                                                                                                                                                                                                                                                study)                                                                               + statusDateRange: IVL<TS>                                                                             +       recordVerificationDate: TS                                                                                                                                                                                                                              number, treatment plan name),             for                                                                                                                              +   resultIndicator: BL
            OrganizationalRelationship                                                                                                                                                                                                                                                                                 plays / is played                                                                                                                                                                                                                                                          +       reviewBoardApprovalRequiredIndicator: BL                                                                                                                                                                                                                nameCode (tumor marker name), or uses                                                                                                                                      +   resultQuantity: PQ
                                                0..*                   +    identifier: II
                                                                                                                                                                                                                                                                                                                       by                                                                                                                                                                                                                                                                         +       scientificDescription: ST                                                                                                                                                                                                                                                                                                                                                                                                          +   resultText: ST
                                                                       +    name: EN.ON                       +player                                                                                                                                                                                                                                                                                 StudySite: can theoretically be any                                                                                                                                                                                                                                                                                                                                                                                                                         association to Intervention (surgery,
    +   effectiveDateRange: IVL<TS.DATETIME>                                                                                                                  plays / is played                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Epoch
                                                                       +    postalAddress: AD                                                                                                                                                                                                                                                          OrganizationFunctionalRole                     OrganizationRole, though, there will be                                                                                                                                                     +       section801Indicator: BL                                                                                                                                                                                                                                 drug/biologic, radiation)                                                                                                                                                  +   typeCode: CD
    +   name: EN.FN                                                                                                                                           by                                                                                OrganizationRole                                                                                                                                                                                                                    StudyContact                                                                                                                                                        is divided into / is a
                                                                       +    statusCode: CD                    0..1                                                                                                          0..*                                                                                                                                                                      some business rules wrt                                                                                                                                                                     +       startDate: TS                                                                            +   name: ST                                                                                                                                                                                                             1                                  1
    +   typeCode: CD                                                                                                                                                                                                                                                            1                                             0..*                                                                                                                                                                                                                                                                                                                      division of
                                             +Target                   +    telecomAddress: DSET<TEL>                                                                                                                                                                                                                                +     functionCode: CD                                                                                                                                                                                                                                       +       startDateTypeCode: CD                            1                                  0..* +
    +   typeCode2: CD                                                                                           plays / is played                                                                                                  ::StructuralRole                                                                                                                                                   StudySite.functionCode (Treating Site,                                + postalAddress: AD                                                                                                                                                                                                        typeCode: CD
                                                           +Source                                                                             IdentifiedEntity                                                                                                                                                                                                                                       Protocol Management Center, Data                                      + roleCode: CD                                                                                                        +       statusCode: CD                                                                                                 1                                                                                                                                                                                     Activity
                                                0..*                                                            by                                                                                                                 + identifier: DSET<II>
                                                                                                              0..1                0..*                                                                                                                                                                                                                                                                                                                                                                                                                                                            +       statusDate: TS
                                                   {is source for}                                                                                                                                                                 + statusCode: CD                                                                                                                                                   Management Center, Statistical Center,                                + telecomAddress: DSET<TEL>
                                                                   1                                                                  + assignedIdentifier: II                                                                                                                                                                                                                                                                                                                                                                                                                                    +       submissionNumber: int                                                                                                                                                                                                                          +   categoryCode: CD
                                                                                                                                                                                                                                                                                                      typeCode identifies type of                                                                     Registration Center, Grantee, Grantor)                                ::FunctionalRole
                                                                                                                                      ::StructuralRole                                                                                                                                                                                                                                                                                                                                                                                                                                            +       targetAccrualNumber: INT                                                                                                                                                                                                                       +   identifier: II
                                                                                                              +player/ is played                                                                                                                                                                      Research Organization as                                                                                                                                              + identifier: II
                                                                                                               plays                  + identifier: DSET<II>                                                                                                                                                                                                                                                                                                                                                                                                                                      +       targetAnatomicSiteCode: CD                                                                                                                                                                                                                     +   statusCode: CD
                                                                                                                                                                                                                                                                                                      defined by SMEs: Cancer                                                                                                                                               + statusCode: CD
                                                                                      Person                   by                     + statusCode: CD                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   +   statusDateRange: IVL<TS>
                                                                                                              0..1               0..*                                                                                                                                                                 Center, Institute,                                                                                                                                                    + statusDateRange: IVL<TS>                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       PerformedObserv ationResult
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             1                                                                                                                                                                                                    contains / occurs in                                   +   subcategoryCode: CD
                                                                        +   birthDate: TS                                                                                                                                                                                                             Cooperative Group, Drug
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         +   textDescription: ST                                                                                                                                      ::ObservationResult
                                                                        +   ethnicGroupCode: DSET <CD>                                                                                                                                                                                                Company, etc. (see class                                                                                                                                                                                                                                                                                                                                    1                                                                                                                                                                               0..*
                                                                                                                                                                                                                                                                                                      definition for specifics)                                    StudySite                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          + resultCode: CD
                                                                        +   identifier: II                                                                                 PersonRole                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 + resultCodeModifiedText: ST
                                                                                                                                                                                                              1                                                                                                                                                                                        StudySiteOv erallStatus                                                                                                                                                                                                                                                                                                                                                                                                                                                           0..*
                                                                        +   name: EN.PN                                                                                                                                                                                                                                                         + accrualDateRange: IVL<TS>                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           + resultDateRange: IVL<TS>
                                                                        +   postalAddress: AD                                                           + postalAddress: DSET<AD>                                                                                                                                                               + actualAccrualNumber: INT                            +    identifier: II                                                                                                                                                        0..*                                                                                                                            uses / associates                                                                                                                                                                                                                                                  PerformedObserv ation
                                                                                                                        plays / is played                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              0..* ArmInterv ention                                                                                                                                                                                                                                                          + resultIndicator: BL
                                                                        +   raceCode: DSET<CD>                                                          + telecomAddress: DSET<TEL>                                                                                                                                                             + localStudyProtocolIdentifier: II         1     0..* +    statusCode: CD                                                                                                                                                                                                                                                                                        from                                                                                                                                                                                             PerformedActiv ity
                                                                                                                        by                                                                                                                                                  ResearchOrganization                                                                                                                                                                                   StudyInv estigator                                                                                                                                                                                                                                                                                                                     PlannedActiv ity                                                                                                                                      + methodCode: DSET<CD> in / is the + resultQuantity: PQ
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       results
                                                                        +   sexCode: CD                0..1                                        0..* ::StructuralRole                                                                                                                                                                        + programCodeText: ST                                 +    statusDate: TS                                                                                                                                     Submission                                                                                                                     Arm             1                                                     is used by /                                                                                                                                                                                                                                       + resultText: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              +     identifier: II associates to                                                                                                             + actualDateRange: IVL<TS>                                                         + targetSiteCode: CD result of
                                                                        +   statusCode: CD                                                              + identifier: DSET<II>                                                                                                                                                                  + reviewBoardApprovalNumber: ST                                                                                                                                                                                                                                                                                                                                                                                                          + alternateName: ST                                                                                                                                                                                                   1 0..* + typeCode: CD
                                                                                                                                                                                                                               HealthCareFacility                      + fundingMechanism: CD                                                                                                                                                                               ::StudyContact                                                                                                                                                                                                                                                                          0..*             1                                                                                                                                                                                          ::PerformedActivity
                                                                        +   telecomAddress: DSET<TEL>                                                   + statusCode: CD
                                                                                                                                                                                                                                                                       + name: EN.ON                                                            + reviewBoardApprovalStatusCode: CD                                                                                         + postalAddress: AD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    cutOffDate: TS                                                                                                               +    description: ST                                                                                      + name: ST                                                                                     0..* + actualDuration: PQ                                                               + actualDateRange: IVL<TS>
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             +    description: ST                                                                                                 1       0..* +    identifier: II                                                                                                                                                                                           + name: ST
                                                                                                                                                                                                                        + name: EN.ON                                  + postalAddress: DSET<AD>                                                + reviewBoardOrganizationalAffiliation: ST                                                                                  + roleCode: CD                                                                                                                                                                                                                                                                                               ::Activity                                                                                                                                                                             + actualDuration: PQ
                                                                                                                                                                                                                                                                                                                                                + targetAccrualNumber: INT                              StudySiteAccrualStatus                                                                                                               +    identifier: II                                                                                                               +    name: ST                                                                                             + categoryCode: CD                                                                                  + nameCode: CD
                                                                                                                                                                                                                        + postalAddress: DSET<AD>                      + telecomAddress: DSET<TEL>                                                                                                                                                                          + telecomAddress: DSET<TEL>                                                                                                                                                                                                                                                                                                                                                                                                                                                                         + name: ST
                                                                                                                                                                                                                                                                                                                                                ::OrganizationFunctionalRole                                                                                                                                                                 +    statusCode: CD                                                                                                               +    typeCode: CD                                                                                                                                                                                             ::Activity
                                                                                                                                                                                                                        + telecomAddress: DSET<TEL>                    + typeCode: CD                                                                                                                  +    identifier: II                                                  ::FunctionalRole                                                                                                                                                                                                                                                                                             + identifier: II                                                                                                                                                                       + nameCode: CD
                                                                                                                                                                                                                                                                                                                                                + functionCode: CD                         1      0..* +                                                                                                                                     +    statusCodeDateRange: IVL<TS>                                                                                                                                                                                                           + statusCode: CD                                                                                    + categoryCode: CD
                                                                                                                                                                                                                        ::StructuralRole                               ::StructuralRole                                                                                                                     statusCode: CD                                                  + identifier: II                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    ::Activity
                                                                                                                                                                                                                                                                                                                                                ::FunctionalRole                                                                                                                                                                             +    title: ST                                                                                                                                                                                                                                                                                                                                  + identifier: II
                                                                                                                                         Patient                                                                        + identifier: DSET<II>                         + identifier: DSET<II>                                                                                                          +    statusDate: TS                                                  + statusCode: CD                                                                                                                                                                                                                                                                                             + statusDateRange: IVL<TS>                                                                                                                                                             + categoryCode: CD
                                                                                                                                                                                                                                                                                                                                                + identifier: II                                                                                                                                                                                                                                                                                                                                                                                                                         + subcategoryCode: CD                                                                               + statusCode: CD
                                                                                                                                                                                                                        + statusCode: CD                               + statusCode: CD                                                                                                                                                                                     + statusDateRange: IVL<TS>                                                                                                                                                                                                                                                                                                                                                                                  0..* + statusDateRange: IVL<TS>                                                         + identifier: II
                                                                                                                        ::PersonRole                                      ClinicalResearchStaff                                                                                                                                                 + statusCode: CD                                                                                                                                                                                                                                                                                                                                                                                                                         + textDescription: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       0..1                                                                                                                                                                                                                                                                  + subcategoryCode: CD                                                              + statusCode: CD
                                                                                                                        + postalAddress: DSET<AD>                                                                                                                                                                                               + statusDateRange: IVL<TS>                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      + statusDateRange: IVL<TS>
                                                                                                                                                                    ::PersonRole                                                                                                                                                                                                           1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 + textDescription: ST
                                                                                                                        + telecomAddress: DSET<TEL>                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             + subcategoryCode: CD
                                                                                                                                                                    + postalAddress: DSET<AD>
                                                                                                                        ::StructuralRole                                                                                                                                Ov ersightCommittee                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  0..*                        is performed during                                                                                                                                    + textDescription: ST
                                                                                                                                                                    + telecomAddress: DSET<TEL>                   OPEN ISSUE: According to CTEP, a
                                                                                                                        + identifier: DSET<II>                                                                                                                                                                                                                                                                                                                                                                                                                                 NOTE: not                                                                                                                                                                                                                                 / uses
                                                                                                                                                                    ::StructuralRole                              HCF can also be a lead organization on                                                                                                                                                                                                                                                                                                                       BRIDG
                                                                                                                        + statusCode: CD                                                                                                                           + typeCode: CD
                                                                                                                                                                    + identifier: DSET<II>                        a trial. Need to evaluate further and                                               0..*                               0..*
                                                                                                                                                                                                                                                                   ::StructuralRole                                                                                                                                                                                                                                                                                            compliant.
                                                                                                                                                                    + statusCode: CD                              assess imapct to PA.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Interv ention            1                                                                                                                                                         PerformedAdministrativ eActiv ity
                                                                                                                              1                                                                                                                                    + identifier: DSET<II>                                                                                 1                                                                                                                                                                                                    Review in next
                                                                                                                                                                                                                                                                                                                                                             scopes / is scoped                                                                                                                                                                                                release against                                                                                                                                                                                                                                                 PlannedObserv ation
                                                                                                                                                                                                                                                                   + statusCode: CD                                                                                                                                                                                                                                                                                                                                                                                                                                                    +    descriptionText: ST
                                                                                                                                                                                                                                                                                                                                                             by                                                                                                                                                                                                                BRIDG 3.0.
                                                                                                                                                    HealthCareProv ider                              OrganizationalContact                                                                                                                                                0..*                                                                                                                                                        0..*                                                                                                                                                                                             +    identifier: II           1
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Consider
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       +    name: ST
                                                                                                                                             + certificateLicenseText: ST                     + title: ST                                                                                                                                                                                                                                                                                                                            StudySubj ect                             renaming this
                                                                                                                                                                                                                                                                                                                                                             StudySiteContact                                                                                                                                                                                                                                       Interv entionalStudyProtocol                                                                                       +    statusCode: CD
                                                                                                                                             ::PersonRole                                     + typeCode: DSET<CD>                                                                                                                                                                                                                                                                                                                                                             to Colleciton
                                                                                                                                                                                                                                                                                                                                                                                                                                                        is the treatment                                                                                                                                                                                                                                                               +    statusDateRange: IVL<TS>
                                                                                                                                             + postalAddress: DSET<AD>                        ::PersonRole                                                                                             resolve the blue-to-blue                    + postalAddress: AD                                                                                                                                                  + assignedIdentifier: ST                                                           +     allocationCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                        location for / is                                                                                                                                                                                                                           NOTE: need                         +    typeCode: CD
                                                                                                                                             + telecomAddress: DSET<TEL>                      + postalAddress: DSET<AD>                                                                                association                                 + primaryIndicator: BL                                                                                                                                               + paymentMethodCode: DSET<CD>                                                      +     blindedRoleCode: DSET<CD>
                                                                                                                                             ::StructuralRole                                                                                                                                                                                                                                                                                           assigned to                                                0..* ::FunctionalRole                                                                                                                                                            to resolve the
                                                                                                                                                                                              + telecomAddress: DSET<TEL>                                                                              StudyParticipation to                       + roleCode: CD                                                                                                                                                                                                                                          +     blindingSchemaCode: CD
                                                                                                                                             + identifier: DSET<II>                                                                                                                                                                                                                                                                                                                                                     + identifier: II                                                                                                                                                            Intervention
                                                                                                                                                                                              ::StructuralRole                                                                                         StudyParticipationContact                   + telecomAddress: DSET<TEL>                                                                                                                                                                                                                             +     designConfigurationCode: CD
                                                                                                                                             + statusCode: CD                                                                                                                                                                                                                                                                                                                                                           + statusCode: CD                                                                                                                                                            class and
                                                                                                                                                                                              + identifier: DSET<II>                                                                                                                               ::FunctionalRole                                                                                                                                                                                                                                        +     interventionTypeCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        + statusDateRange: IVL<TS>                                                                                                                                                  PlannedProce
                                                                                                                                                                                              + statusCode: CD                                                                                                                                     + identifier: II                                                                                                                                                                                                                                        +     numberOfInterventionGroups: INT
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    dure and                                       PlannedProcedure                  PlannedSubstanceAdministration                 PlannedEligibilityCriterion
                                                                                                                                                                                                                                                                                                                                                   + statusCode: CD                                                              PersonRole may fill FunctionalRole on a study                                                                                                                             +     studyClassificationCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 0..*           0..1                                                                                                                                PlannedSA for
                                                                                                                                                                                                                                                                                                                                                   + statusDateRange: IVL<TS>                                                                                                                                                                                                                                                                                                                                                              + methodCode: CD                                                                     + cdePublicIdentifier: INT
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    3.1 release                                                                      + dose: IVL<PQ>
                                                                                                                                                                                                                                                                                                                                                                                                                                 StudyContact: not restricted as to who can play                                                                                                                                                                                                                                                           + targetSiteCode: CD                                                                 + cdeVersion: ST
                                                                                                                                                                      Address of Person-in-a-role at Organization                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    + doseDescription: ST
                                                                                                                                    Business Rule: For                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     ::PlannedActivity                                                                    + criterionName: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     + doseDuration: <PQ>
                                                                                                                                    Intervention Trials,                                                                                                                                                                                                                                                                         StudyInvestigator: this is the PI; for CTEP studies, Investigator must be                                                                                                                                                                                                                                 + alternateName: ST                                                                  + displayOrder: INT
                                                                                                                                                                      Dr. Smith is HCP (person structural role) with           For Jan 2009                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          + doseFormCode: CD
                                                                                                                                    a StudyInvestigator                                                                                                                                                                                                                                                                          HealthCareProvider; for DCP studies, Investigator must be HealthCareProvider                                                                                                                                                                                                                              + name: ST                                                                           + eligibleGenderCode: CD
                                                                                                                                                                      an association to organization Mayo, AZ                  reelase this class                                                 applicable where                                                                                                                                                                                                                                                                                                                                                                                                                                                                   + doseFrequencyCode: CD
                                                                                                                                    MUST be a                                                                                                                                                                                                                                                                                    when Investigational Agent is involved, otherwise, Investigator can be either                                                                                                                                                                                                                             ::Activity                                                                           + inclusionIndicator: BL
                                                                                                                                                                      (organization structural role Institution) with an       is being used to                                                   StudySite.functionCode =                                                                                                                                                                                                                                                                                                                                                                                                                                                           + doseRegimen: ST
                                                                                                                                    HealthCareProvider                                                                                                                                                                                                                                                                           HealthCareProvider or ClinicalResearchStaff; no restriction as to Organization                                                                                                                                                                                                                            + categoryCode: CD                                                                   + operator: ST
                                                                                                                                                                      address                                                  capture the                                                        'TreatingSite'                                        StudySiteInv estigator                                                                                                                                                                                                                                                                                                                                                                                                       + doseTotal: IVL<PQ>
                                                                                                                                    . For all other                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        + identifier: II                                                                     + structuredIndicator: BL
                                                                                                                                                                      same Dr. Smith is a HCP with an association              Responsible Party                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     + radiationMachineType: CD
                                                                                                                                    Trials                                                                                                                                                                                                                                                                                       StudySiteContact: not restricted as to who can play from role perspective, but,                                                                                                                                                                                                                           + statusCode: CD                                                                     + textValue: ST
                                                                                                                                                                      to organization Scottsdale CCOP (CCOP) with              contact and IRB                                                                                                     ::StudySiteContact                                                                                                                                                                                                                                                                                                                                                                                                                + routeOfAdministrationCode: CD
                                                                                                                                    (Observational, Epi,                                                                                                                                                                                                                                                                         must be a person with association to study site                                                                                                                                                                                                                                                           + statusDateRange: IVL<TS>                                                           + value: IVL<PQ>
                                                                                                                                                                      a different address                                      contact                                                                                                             + postalAddress: AD                                                                                                                                                                                                                                                                                                                                                                                                               ::PlannedActivity
                                                                                                                                    etc.), a                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               + subcategoryCode: CD                                                                ::PlannedActivity
                                                                                                                                                                                                                                                                                                                                                   + primaryIndicator: BL                                                                                                                                                                                                                                                                                                                                                                                                            + alternateName: ST
                                                                                                                                    StudyInvestigator                                                                                                                                                                                                                                                                            StudySiteInvestigator: see above regarding CTEP and DCP studies and must                                                                                                                                                                                                                                  + textDescription: ST                                                                + alternateName: ST
                                                                                                                                                                                                                                                                                                                                                   + roleCode: CD                                                                                                                                                                                                                                                                                                                                                                                                                    + name: ST
                                                                                                                                    need not be a                                                                                                                                                                                                                                                                                be a person with association to study site                                                                                                                                                                                                                                                                                                                                                     + name: ST
                                                                                                                                                                                                                                                                                                                                                   + telecomAddress: DSET<TEL>                                                                                                                                                                                                                                                                                                                                                                                                       ::Activity
                                                                                                                                    HealthCareProvider                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          ::Activity
                                                                                                                                                         For Jan 2008                                                                                        RegulatoryAuthority                                                                   ::FunctionalRole                                                                                                                                                                                                                                                                                                                                                                                                                  + categoryCode: CD
                                                                                                                                    .                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           + categoryCode: CD
                                                                                                                                                         release of CTRP,                                                                                                                                                                          + identifier: II                                                                                                                                                                                                                                                                                                                                                                                                                  + identifier: II
                                                                                                                                                                                  NOTE: For the first few releases of PA,                               + countryCode: CD                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       + identifier: II
                                                                                                                                                         the                                                                                                                                                                                       + statusCode: CD                                                                                                                                                                                                                                                                                                                                                                                                                  + statusCode: CD
                                                                                                                                                                                  RegulatoryAuthority will not have a 'played by'                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               + statusCode: CD
                                                                                                                                                         HealthCareProvid                                                                               + jurisdictionCode: CD                                                                     + statusDateRange: IVL<TS>                                                                                                                                                                                                                                                                                                                                                              NOTE: In a future release of              + statusDateRange: IVL<TS>
                                                                                                                                                                                  association to an Organization because the                            + name: ST                                                                                                                                    StudyRegulatoryAuthority                                                                                                                                                                                                                                                                                                                                                                                                  + statusDateRange: IVL<TS>
                                                                                                                                                         er is ONLY                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        COPPA (post 3.1) -- the                   + subcategoryCode: CD                                                                                                                                                            PerformedSubj ectMilestone
                                                                                                                                                                                  management of those organizations is not yet resolved.                ::StructuralRole                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        + subcategoryCode: CD
                                                                                                                                                         scoped to                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         PlannedSubstanceAdminsitratio             + textDescription: ST
                                                                                                                                                                                  Instead, for this release, an official list of regulatory             + identifier: DSET<II>                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  + textDescription: ST                                                                                                           + informedConsentDate: TS
                                                                                                                                                         licensed                                                                                                                           1                                                                                                  1..*                              1                                                                                                                                                                                                                                                                                                         n needs to be associated to                                                                                                                                                                                                                                     NOTE: BRIDG
                                                                                                                                                                                  agencies will be provided to and managed by PA                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                + missedReason: SET<CS>
                                                                                                                                                         physicians who                                                                                 + statusCode: CD                                                                                                                                                                                                                                                                                                                                                                                                                                                                   StudyAgent and Product classes
                                                                                                                                                                                  rather than by PO. The two attributes name and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                + reasonCode: CD                           3.0 has changed
                                                                                                                                                         are MD, DO, etc.         countryCode were added to accommodate this and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           as in BRIDG. Due to time                                                                                                                                                                                                                                        this class name to
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                + registrationDate: TS
                                                                                                                                                         Long term this           may be removed later when the management of these                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        contraints, the Product,                                                                                                                                                                                                                                        PerformedStudyS
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                ::PerformedActivity
                                                                                                                                                         may include RNs          regulatory organizations is worked out.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  TherapeuticAgent and                                                                                                                                                                                                                                            ubjectMilestone.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 NOTE:                                                                                                                          + actualDateRange: IVL<TS>
                                                                                                                                                         and other                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         StudyAgent classes have not                                                                                                                                                                                                                                     Harmonize later.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 cdePublicIdentifier                                                                                                            + actualDuration: PQ
                                                                                                                                                         licensed entities.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                been implemented in 3.1
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 and cdeVersion                                                                                                                 + name: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           release of COPPA.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 attributes have                                                                                                                + nameCode: CD
                                                                                                                                                                                                                                                                                                                                         plays / is played                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      ::Activity
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 been added here
                                                                                                                                                                                                                                                                                                                                         by                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     + categoryCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            participates in / is                                                                                                                                                                                                                 for now as a
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            performed for                                                                                                                                                                                                                        placeholder in                                                                                                                 + identifier: II
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 support of release                                                                                                             + statusCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 3.1. In future                                                                                                                 + statusDateRange: IVL<TS>
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 release, the                                                                                                                   + subcategoryCode: CD
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 interactions with                                                                                                              + textDescription: ST
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 caDSR could result
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 in an alternate
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 design for this
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 implementation.




                                                       FunctionalRoles and the StructuralRoles that play them:
                                                       FunctionalRole:            StructuralRole(s) that can play them
                                                       StudyProduct:              TherapeuticProtoduct
                                                       StudyParticipation:        HealthCareFacility, ResearchOrganization, RegulatoryAuthority ,OversightCommiittee
                                                       StudySiteAccrualStatus:           (not played by anything since it is not really a functionalRole)
                                                       StudyParticipationContact: HealthCareProvider, ClinicalResearchStaff, OrganizationalContact
                                                       StudySiteInvestigator:            HealthCareProvider, ClinicalResearchStaff
                                                       StudyContact:              HealthCareProvider, ClinicalResearchStaff
                                                       StudyInvestigator:         HealthCareProvider, ClinicalResearchStaff

                                                       StudyParticipation.functionCodes:               StructuralRoles that can play them
                                                       Treating Site:                    HealthCareFacility
                                                       Protocol Management Center:              ResearchOrganization
                                                       Data Management Center:           ResearchOrganization
                                                       Registration Center:              ResearchOrganization
                                                       Statistical Center:               ResearchOrganization
                                                       Funding Source:                   ResearchOrganization
                                                       Funding Recipient:                HealthCareFacility, ResearchOrganization
                                                       Lead Organization:                HealthCareFacility, ResearchOrganization
                                                       Laboratory:                       ResearchOrganization
                                                       Non-Monetary Source:                     ResearchOrganization
                                                       Sponsor:                          ResearchOrganization
                                                       Study Regulatory Authority:              RegulatoryAuthority
                                                       Study Oversight Committee:               OversightCommittee
                                                       Agent Source:                     ResearchOrganization
                                                       Responsible Party - Sponsor:             ResearchOrganization
                                                       Identifier Assigner:              IdentifyingOrganization

                                                       StudyContact.roleCodes:                   StructuralRoles that can play them
                                                       Submitter:                         HealthCareProvider, ClinicalResearchStaff
                                                       Responsible Party - Principal Investigator:      HealthCareProvider, ClinicalResearchStaff
                                                       Principal Investigator:                   HealthCareProvider, ClinicalResearchStaff
                                                       Central Contact:                   HealthCareProvider, ClinicalResearchStaff
                                                       Backup Contact:                    HealthCareProvider, ClinicalResearchStaff

                                                       StudyParticipationContact.roleCodes:         StructuralRoles that can play them
                                                       Responsible Party - Sponsor Contact:         HealthCareProvider, ClinicalResearchStaff
                                                       Facility Contact (for specific case): ClinicalResearchStaff
                                                       Facility Investigator:        HealthCareProvider, ClinicalResearchStaff

                                                       OrganizationalContact.roleCodes:
                                                       IRB Contact
                                                       Facility Contact (for generic case)

                                                       PlannedActivity.categoryCodes PlannedActivity.subcategoryCodes
                                                       Intervention              Drug, Device, Biological/Vaccine, Procedure/Surgery, Radiation, Behavioral, Genetic, Dietary Supplement, Other - perhaps we should add Cosmetic just so we could distinguish between a product Other and non-product Other?
                                                       Eligibility Criterion:    (not used)

                                                       PlannedEligibilityCriterion.names:
                                                       ender
                                                       Minimum Age
                                                       Maximum Age
                                                       (plus ad hoc values entered by user)
                Mayo Clinic
Proposed Model for CTRP 3.4 - (Close Up)
PO Screen Mockups

• Browse/Mouse Over or Scroll Function in addition to
  Search (can be used in Reg, PA, PO)
• Include search by Family Name for Organization
• Organization Search Results Page would include Family
  Name
• Organization Name/Relationship Curation functions
    • Select an organization
    • Add relationships to other organizations for selected
      organization
•
Organization Look Up




                                                                 ^
                                              Browse Org >   Duke     >
                                                             Fox Cha >
                                                             M D And >
                                                             Mayo    >    Mayo Rochester
                                                             Wake For >   Mayo Scottsdale
                                                                  v       Mayo Jacksonville
                                                                          Mayo Clinic Hospital
                                                                          Mayo Hospital
                                                                          Saint Mary’s Hospital
                                                                                   v




Add a button with roll over or click and roll to allow the user to
quickly browse for find an organization
Organization Search




           Org Family Name




Add Organization Family Name to Find Organization screen
Organization Search




                         Family Name




Add Family Name to search Organization screen
Organization Inbox




             Org Family




             Duke Univ

             Mayo Clini
             WFCC




Add Family Name to search results table
Organization Details




      Manage Organization Family (0)




Add Manage Organization Family Role to Organization
Details Screen
Create an Edit Organization Family




                                                                                     Edit Organization Family
       Edit Organization Family                                                      Screen and include
       Organization Family                                                           the following fields:

                                                                                     Organization Name
                                                                                     Family Name
        Organization Family Information                                              Relationship Type
        Organization Family Name
                                                                                     Other Relationship Type
         Family Name
                                                                                     Effective Dates
         Related Organization                 Browse
       Relationship Type:                                                            Functions for editing and
                                                                                     deleting the relationship
       Other Relationship Type:

      Effective Dates:
       Start Date:         End Date:

       Relationships:
        Organization   Family Name   Relationship   Relationship Type   Effective Dates    Select

        Baylor COM     Baylor        Parent         Organizational      1/1/2000 -         Edit / Delete

        Baylor MC      Baylor        Child          Organizational      1/1/2000 -         Edit / Delete
Next Steps

• Identify Issues
• Review with Development Team, Architecture, Key
  Stakeholders (CTEP, DCP)
• Propose model changes to BRIDG?

								
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