Michele Ehlman Essex Management February 4 th 2010

1. CTMS Face to FaceFebruary caBIG® Biomedical Research Business Architecture ModelReal World Use of the BAM – its not just a bunch of bubbles Michele Ehlman Essex Management February 4th 2010

2. Agenda • Welcome • Biomedical Research Architecture Model (BAM) Overview • Purpose of a BAM • Components of a BAM • Utilizing the BAM • Maturing the BAM • Use Cases - Scott Hunicke-Smith • Panel Discussion

3. A Biomedical Research 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, Definition The Biomedical Research Architecture Model (BAM) is a blueprint of biomedical research. 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.

4. Why… Modeling the key goals and workflows of research provides a starting point allowing us to organize the use cases that represent the many aspects and flavors of Biomedical Research… because…

5. A Model can tell a 1000 Pictures By utilizing the pieces of the BAM we are able to identify the patterns that represent the many aspects of Biomedical Research.

6. Function – Develop Systems Requirements • Identify business requirements for software development • providing use cases and workflows to help developers understand how the software will be used • definitions for actors and roles that will use the software • Assist in defining technical requirements through alignment with BRIDG and Workspace Specific DAMs

7. Function – Identify Common Requirements • Mapping of Current Applications • Tagging Use Cases in Enterprise Architect (EA) allows that we can see which use cases are represented in multiple applications. • This can point to future service development • Identify possible application gaps

8. Function – Increase Interoperability Allow for an over-arching alignment of strategic objectives across domains and a framework for interoperability

9. Function – Enhance Training To provide training to non life scientists to help them understand the research process

10. Who Uses A Biomedical Research Architecture Model? http://www.123rf.com/photo_2885663.html

11. Components of a BAM Use Case Identify Specimens Scenario 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 Workflow Common Vocabulary * All four (4) are required to have a clear understanding of the process

12. Example: Develop Requirements • Mayo Clinic - has used the CTMS BAM to identify requirements for the CTMS system they are looking to implement. • They reviewed v1.0 and v1.1 by placing it into a spreadsheet and vetting it with cancer and non-cancer subject matter experts.  • They found it ~99% accurate and made only minor changes, which were specific to their processes.   • They are now mapping the functions to their requirements and modules to ensure all of the functions are accounted for in the new system design.

13. Example: Develop System Requirements • BAM is currently being used by Cancer Electronic Health Records (caEHR) team, Clinical Trials Reporting Program (CTRP) and the Protocol Lifecycle Tracking (PLT) team to identify business requirements for current/future system development. • caEHR – is being used to assure that the required clinical trials elements are integrated into the electronic health care record. To allow full tracking of an individuals health care. • CTRP – used the BAM to identify the gaps in captured data elements and required data elements to add Summary 4 reporting functionality. • PLT – utilizing the BAM to define a set of common stages, activities, and milestones in order to facilitate report and metric generation.

14. Example: Identify Common Requirements • Enterprise Services –uses the CTMS BAM to understand the processes in clinical trials. Works with CTMS analysts and SMEs to identify and understand common business requirements which allows them to develop functional specifications for services. • To Date the following services have used the BAM. • Subject Registration Service • Adverse Event Service • Subject Management Service • Study Schedule Service

15. Example: Interoperability • HEAS, SAEAF require a BAM • The BAM is used by VCDE for ECCF compatibility evaluations

16. Example: Interoperability Develop comprehensive and integrated Enterprise Use Cases for the Population Sciences and Cancer Control Community • Document Use Cases for Interoperability • Work with caBIG Pop Sci and other caBIG members to solicit user stories from the cancer control and population science research community as well as participants from the other domain workspaces that will be used to create Use Case storyboards • Relevant Enterprise Use cases and integration points will be decided on by the EUC Team (with the help of the whole group) and then further vetted with groups of interest • Updates will be made to BAM • portfolio analysis will proceed. Gene Kraus, Population Sciences Enterprise Use Cases Group, November 19th 2009

17. Example: Training • Developers and Informatics team • Allows them to understand the processes they are developing for and supporting • Wake Forest – utilizes the BAM in the training of the Informatics team to help them understand the clinical trial process to better allow them to develop tools for clinical trials and provide support to their clinicians and researchers. • Patient Advocates – are in the process of producing simplified version of the CTMS BAM to allow advocates to help patients understand the clinical trial process from a patients point of view.

18. Maturing the BAM • CTMS BAM v 2.0: Completing existing use cases in conjunction with the caBIG Community • BAM Integration: solidify the integration of the BAM with BRIDG and services team • Expansion of BAM: LS, Imaging, Patient, etc

19. Functional uses of a Business Architecture Model Platform of Communication

20. Acknowledgements Sharon Elcombe – CTMS SME, Mayo Clinic Bob Morrell – CTMS SME, Wake Forrest Brian McIndoe – CBIIT Enterprise Services, Ekagra Software Paul Davis – CBIIT Analyst, Essex Management Diane Paul – Patient Advocate Elaine Freund, ICR Workspace Lead, 3rd Millennium

21. Questions

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

23. 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 Additional information is also available at https://cabig-kc.nci.nih.gov/CTMS/KC/index.php/BAM For more information about the caBIG® Clinical Trials Management Systems Workspace, please visit https://cabig.nci.nih.gov/workspaces/CTMS/ NCI caBIG® Knowledge Center Website https://cabig-kc.nci.nih.gov/MediaWiki/index.php/Main_Page CTMS Forum https://cabig-kc.nci.nih.gov/CTMS/forums/ Biomedical Research BAM page: https://cabig-kc.nci.nih.gov/CTMS/KC/index.php/Biomedical_Research_Business_Architecture_Modeling