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CTMS Face to Face caBIG ® Biomedical Research Business Architecture Model Real World Use of the BAM

CTMS Face to Face caBIG ® Biomedical Research Business Architecture Model Real World Use of the BAM . Michele Ehlman Essex Management February 4 th 2010. Agenda. Welcome What is a Business Architecture Model (BAM) Why a Model What are the Functions of the BAM with Examples

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CTMS Face to Face caBIG ® Biomedical Research Business Architecture Model Real World Use of the BAM

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  1. CTMS Face to Face caBIG® Biomedical Research Business Architecture ModelReal World Use of the BAM Michele Ehlman Essex Management February 4th 2010

  2. Agenda • Welcome • What is a Business Architecture Model (BAM) • Why a Model • What are the Functions of the BAM with Examples • Use Cases- Scott Hunicke-Smith • Panel Discussion

  3. A 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, Definition The Biomedical Research Business 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. Pieces 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

  5. Who Uses A Business Architecture Model? http://www.123rf.com/photo_2885663.html

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

  7. 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 Life Sciences… because…

  8. 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 Life Science Research.

  9. Function - 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 LS DAM and BRIDG

  10. Requirements -Examples • 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.

  11. Requirements -Examples • Enterprise Services –uses the CTMS BAM to understand the processes in clinical trials. Works with CTMS analysts and SMEs to identify and understand 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

  12. Requirements –Application -Examples • Applications – BAM is currently being used by caEHR team and the Protocol Lifecycle Tracking (PLT) team to identify business requirements, Clinical Trials Reporting Program (CTRP) • 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.

  13. Example – Protocol Life Cycle Tracking (PLT) PLT is a tool designed to track and manage the key milestones and activities related to the planning, initiating, conduct, and closeout of a clinical study. In addition it helps identify potential bottlenecks in a study’s progress. In order to create a set of standard metrics and reports, a set of common stages, activities, and milestones must be defined up-front that will be captured for all studies.

  14. Example – Protocol Life Cycle Tracking (PLT) • Identification of common activities and milestones throughout the study lifecycle that can be applied to all studies regardless of type or sponsor. • Starting with the 4 high level use cases, as the 4 key stages in the study lifecycle: Plan Study, Initiate Study, Conduct Study, and Report and Analyze Study. • Direction to define standard templates to be included

  15. Function – View into current and future activities • 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

  16. Example: Facilitate Development of Functional Requirements • Pre-BAM  • C3PR user-defined requirements documented the capture of the initial informed consent for each subject • The informed consent function within C3PR was built upon the user-defined functional requirements • Upon deployment it was discovered that a specific sub-set of requirements related to pediatric studies was not captured: • Guardian consent with Subject Assent • Use of an interpreter • Re-consent of a minor at the age of majority • User group participants did not have specific experience in pediatric studies.

  17. Example: Facilitate Development of Functional Requirements • Post-BAM • Utilizing the BAM as a starting point reduces the potential for gaps between business process and functional/system requirements by documenting all of the relevant business scenarios, use cases, workflows, and actors. • The BAM allows application development teams to quickly identify all business processes that are directly or indirectly related to the project and decide which ones fall within scope. • The BAM allows application development teams to ensure there is adequate representation from the appropriate SMEs to address all business requirements.

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

  19. Interoperability • HEAS, SAEAF require a BAM • The BAM is used by VCDE for ECCF evaluations

  20. Interoperability – Pop Sci 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

  21. Function - Training To provide training to non life scientists to help them understand the research process

  22. Training Examples • 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.

  23. Training Examples • 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.

  24. The Answer • Text books provide a basic knowledge • The BAM provides • Understanding • Practical Knowledge • “The Big Picture”

  25. 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

  26. Questions

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

  28. 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

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