1. Touch Points – Imaging and the BAM Imaging Face to Face May 10, 2010 Michele Ehlman Contractor, Center for Biomedical Informatics and Information Technology Essex Management Imaging Face to Face May 10, 2010 Michele Ehlman Contractor, Center for Biomedical Informatics and Information Technology Essex Management Touch Points – Imaging and the BAM 1

2. Agenda - Overview Welcome caBIG and Lego What is the Business Architecture Model Imaging/BAM – Current touch points Questions Thank- you

3. LEGOLAND IMAGE

4. But did you know?

5. The key points… One of the key features of Lego bricks throughout their history is that they are, first and foremost, part of a system. Each new series and set that is released is compatible with the rest of the system; Lego pieces regardless of their size, shape or function, fit together with all other Lego pieces in some way.

6. Lots of different types of models…using different types of bricks…

7. Processes and Tools that will us to get us there Semantic Service Oriented Architecture (sSOA) Provide Business Models to identify and support business processes, requirements and interoperability Scenarios Business Use Cases Workflows/Activity Diagrams Domain Models Enterprise Conformance and Compliance Framework (ECCF)

8. Which will allows us to accomplish our Bench to Bedside and Back goal

9. The BAM BAM

10. A Translational Medicine Business Architecture Model (BAM) "A blueprint of the enterprise that provides a common understanding of the organization and is used to align strategic objectives and tactical demands." Object Management Group, Business Architecture Working Group, DefinitionDefinition The Translational Medicine Business Architecture Model (BAM) is a blueprint of translational medicine. It documents a common understanding of the information, “what, who, how, where and when,” necessary to realize research, so that it is accessible to someone, who is not directly involved in research to align strategic objectives and meet tactical demands - providing a communications platform.

11. Components of the Translational Medicine BAM Scenarios A scientist is trying to identify a new genetic biomarker for HER2/neu negative stage I breast cancer patients. Using a caGRID-aware client, the scientist queries for HER2/neu negative tissue specimens of Stage I breast cancer patients Identify Specimens Use Cases Workflow/Activity diagrams Common Vocabulary (EVS, caDSR & CRFs) Domain Analysis Models

12. Scenario (Also known as Enterprise Use Cases, Interoperability Scenarios) Paints the picture of an overarching goal to be accomplished and generally captures workflow represented as an outline or manuscript of the projected sequence of events which contains the primary and secondary (or more) goals required to realize the ultimate goal. There are two main types Broad Spectrum and Specific.

13. Use Cases – Business vs. Functional (the amount of information required to make them complete) Business Use Cases Description of the Key goal Storyboard Actors Pre-conditions Basic Flow of Events Post- conditions Notes (Meant to provide the basis for future functional use cases) Functional Use Cases Description of the goal and the functionality to accomplish Storyboard Actors Primary and Secondary (including system interactions) Pre-conditions Work flow (including alternate flows, decision points failure conditions…) Post- conditions Notes

14. Business Use Case A use case is initiated by a user with a particular goal in mind, and completes successfully when that goal is satisfied. The Business Architecture Model (BAM) provides a description of the relevant aspects of the business that the enterprise architecture should, by definition, be designed to support. Typically, this will consist of a description and models of key business processes and functions, as well as a description of the organizational structure and environment in which the enterprise operates. 1 Focuses on the business process and is an easy to understand, conceptual representation of a task or interaction that is captured in a technology-free and implementation-independent description. 1-http://ec2-174-129-196-76.compute- 1.amazonaws.com/mediawiki/index.php/5_BIG_HEAS:_Components_of_EAFhttp://ec2-174-129-196-76.compute- 1.amazonaws.com/mediawiki/index.php/5_BIG_HEAS:_Components_of_EAF

15. Functional Use Case – how they are used Describes the sequence of interactions between actors and the system necessary to deliver the service that satisfies the goal. It also includes possible variants of this sequence, e.g., alternative sequences that may also satisfy the goal, as well as sequences that may lead to failure to complete the service because of exceptional behavior, error handling, etc. A complete set of use cases specifies all the different ways to use the system, and therefore defines all behavior required of the system, bounding the scope of the system.

16. Supporting Use Cases (enterprise, organizational, regulatory) Use Cases not directly involved with research but are required to support research Includes but not limited to: Procurement process Permissions Data management

17. Workflows and Activity Diagrams Note: In the Unified Modeling Language, activity diagrams can be used to describe the business and operational step-by-step workflows of components in a system. Workflows Serves as a visual representation of step-by-step activities and actions, in logical order, with support for choice, iteration and concurrency required to accomplish a specific goal (use cases) Provides basic knowledge so that the goal can be easily communicated and understood. Activity Diagrams A graphical representations of the over all process flow which is made up of multiple workflows (Enterprise Use Cases, Scenarios)

18. Domain Model (DAM) & Vocabulary A Domain Analysis Model (DAM) is an abstract representation of a subject area of interest which is complete enough to allow instantiation of all necessary concrete classes needed to develop specialized, DAM-derived design artifacts. A complete DAM contains a static model (class and instance diagrams) and a dynamic model (activity and occasional state diagrams) PLUS a glossary that unambiguously defines all of the relevant terms used in the two models. The relationship between the static and dynamic models should be consistent, e.g. static structures referenced in process flows should be fully explained in the static model and states named as members of the value set for a statusCode attribute for a given class should be fully defined in the context of a detailed state diagram which describes the life cycle of instances of the class. 2 a shared view of the dynamic and static semantics for an area of interest. It relates the concepts and objects of the domain to each other This model does not include software The objects in the domain model are candidates for programming objects 2 - http://ec2-174-129-196-76.compute- 1.amazonaws.com/mediawiki/index.php/5_BIG_HEAS:_Components_of_EAFhttp://ec2-174-129-196-76.compute- 1.amazonaws.com/mediawiki/index.php/5_BIG_HEAS:_Components_of_EAF

19. Translational Medicine Business Model Facilitates… Requirements BusinessSystems Common/ Duplicate Training Across Workspaces SupportDevelopers

20. Function – of a Business Model Identify business requirements for software development Use cases and workflows help developers understand how the software they are building will be used by the community. Actors and roles identify who will use the software. Assist in defining semantics through alignment with BRIDG and Workspace Specific DAMs Identification of common requirements across systems to increase interoperability As a training aid for developers and support personnel

21. Who is using the Translational Medicine BAM? Currently using the Translational Medicine BAM for requirement identification, development and/or training. List of Institutions, Industry and Vendors (Includes but not limited to): Duke Harvard Mayo Clinic Columbia Wake Forest St. Jude’s Teradata Medimmune

22. Imaging Touch points

23. Manage Clinical Research

24. Plan Study touch points

25. Close-up of the Plan Study Scientific Plan Touch points

26. An Outline of Touch Point Use Cases Plan Study Develop Protocol and Associated Materials Develop Scientific Plan Define Measures Define Criteria to Evaluate Response Define Response Criteria Interpretation Method Define DICOM Viewer Define Image Annotation Tool Define Image Annotation Template Define Ancillary Studies Define Image Methods for Ancillary Studies

27. Define Image Events

28. Assess Potential Participating Site Imaging Facility Capabilities

29. Develop Plan for Response Assessment

30. Activate a Study at the Coordinating Center

31. Maintain Local/Center Radiology Sites

32. Initialize Image Management System

33. Initialize Response Criteria Interpretation Method

34. Initiating the Study at a Site Open Study at the Site Verify Image Transfer Infrastructure Conduct Study-Specific Personnel Training Train Staff On Response Assessment Methods Train Staff On Image Acquisition Methods

35. Current BAM Status Clinical Research For Translational Medicine BAM 2.0 (delivery August 2010) Complete the review and approve use cases for Plan Study Complete Initiate Study Use Cases Complete Conduct Study Use Cases Life Sciences Delivered a high level LS BAM version 1.0 for inclusion in the Translational Medicine BAM 2.0 Currently working on the Actor identification Extension of the use cases in LS BAM 1.0

36. Current BAM Status continued Population Sciences The Population Science working group is working to assure that the required use cases for conducting studies and trials to support the Division of Cancer Control and Population Sciences are accurately captured in the Translational Medicine Architecture BAM Just getting started Mapping scenarios to the current Translational Medicine BAMs and extending as needed Extending the Plan Study Area of the Clinical Research BAM for v. 2.0

37. Current BAM Status continued Patients The Patient BAM will describe a cancer patient’s interaction with the Translational Medicine community, specifically related to clinical trials. This includes the evaluation, diagnosis, and treatment of a patient’s cancer as it relates to a patient deciding to participate in a cancer clinical trial. This will provide the patient’s perspective for consideration when developing requirements for systems to support the clinical trial domain. Began working in January Identified 4 high level use cases Currently working on Obtain Diagnosis use case

38. Maturing the Translational Medicine BAM Translational Medicine BAM v 2.x: Incorporate the work from each of the workspaces. Translational Medicine BAM Integration: Continue working with the Development, BRIDG and Enterprise Services Teams on integration and alignment. Expansion of Translational Medicine BAM: Expand current Clinical Research and Life Sciences to include (Tissue Banking & Pathology, Imaging, Population Science, Patients, etc.

39. Acknowledgements CTMS Sharon Elcombe CTMS SME, Mayo Clinic Bob Morrell CTMS SME, Wake Forrest CBIIT Catherine Lasome Chief Operating Officer, National Cancer Institute, CBIIT Denise Warzel Associate Director, National Cancer Institute, CBIIT Robert Shirley National Cancer Institute, CBIIT Enterprise Services Santosh Joshi CBIIT Enterprise Services, Ekagra Software Brian McIndoe CBIIT Enterprise Services, Ekagra Software Life Sciences Elaine Freund LS Workspace Lead – 3 rd Millennium Imaging Mia Levy, M.D. Vanderbilt Ingram Cancer Center

40. Questions

41. Thank-you Michele Ehlman michele.ehlman@nih.gov 860-235-8125 michele.ehlman@nih.gov

42. Links BAM 1.1 The caBIG® Biomedical Research Business Architecture Model is available through https://cabig.nci.nih.gov/workspaces/CTMS/workspaces/CTMS/Business_Arch_Model https://cabig.nci.nih.gov/workspaces/CTMS/workspaces/CTMS/Business_Arch_Model Additional information is also available at https://wiki.nci.nih.gov/x/fwcpAw (updated October 2012)https://wiki.nci.nih.gov/x/fwcpAw For more information about the caBIG® Clinical Trials Management Systems Workspace, please visit https://cabig.nci.nih.gov/workspaces/CTMS/https://cabig.nci.nih.gov/workspaces/CTMS/ CTMS Forum https://cabig-kc.nci.nih.gov/CTMS/forums/