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CTMS Face to Face February 4 th 2010 caBIG ® Biomedical Research Business Architecture Model Overview and Discussion

CTMS Face to Face February 4 th 2010 caBIG ® Biomedical Research Business Architecture Model Overview and Discussion Panel. Michele Ehlman Essex Management February 4 th 2010. Biomedical Research Architecture Model Overview and Discussion Panel. CTMS Face to Face Meeting

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CTMS Face to Face February 4 th 2010 caBIG ® Biomedical Research Business Architecture Model Overview and Discussion

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  1. CTMS Face to FaceFebruary 4th 2010 caBIG® Biomedical Research Business Architecture ModelOverview and Discussion Panel Michele Ehlman Essex Management February 4th 2010 Biomedical Research Architecture Model Overview and Discussion Panel CTMS Face to Face Meeting February 4, 2010 MD Anderson, Houston Texas Michele Ehlman Contractor, Center for Biomedical Informatics and Information Technology Essex Management 1

  2. Agenda • Welcome • Biomedical Research Architecture Model (BAM) Overview (Michele Ehlman) • BAM- An Academic View (Scott Hunicke-Smith1) • Panel Discussion (Scott Hunicke-Smith1, Sharon Elcombe2, Bob Morrell3, Gene Kraus4)

  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 to align strategic objectives and meet tactical demands - providing a communications platform.

  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. Biomedical Research Architecture ModelFacilitates… Communication Development of Standards

  7. Function – Develop Systems Requirements • 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 technical requirements through alignment with BRIDG and Workspace Specific DAMs

  8. 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 potential future service development. • Identify possible application gaps.

  9. Function – Increase Interoperability • Big Health Enterprise Architecture Specification (HEAS) and the Services Aware Interoperability Framework (SAIF) require a Business Model as one of their key components. http://ec2-174-129-196-76.compute-1.amazonaws.com/mediawiki/index.php/5_BIG_HEAS:_Components_of_EAF Pg 39, SAEAF – Services –Aware Enterprise Architecture Framework handbook, January 19th 2010 https://gforge.nci.nih.gov/docman/index.php?group_id=640&selected_doc_group_id=5460&language_id=1 • Vocabularies and Common Data Elements requires alignment with the BAM in their silver compatibility evaluations • The BAM helps to provide the conceptual and business context during service specifications built by the Enterprise Service Specification Team (ESST) https://wiki.nci.nih.gov/display/EAWiki/Enterprise+Conformance+and+Compliance+Framework+%28ECCF%29

  10. Function – Provide Training To provide training to non clinicians and scientists to help them understand the research process allowing for better communication

  11. Components of the Biomedical Research Architecture Model Use Case 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 Identify Specimens Workflow Common Vocabulary (caDSR & CRFs) * All four (4) are required to have a clear understanding of the process

  12. All of which needs to align to BRIDG BRIDG

  13. Example: Develop System Requirements The 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 – using 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 Clinical Trial Management System (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 • Develop comprehensive and integrated Enterprise Use Cases for the Population Sciences (Pop Sci) 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 Enterprise Use Case (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

  16. 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. http://medicineworld.org/news/news-archives/health-news/Aug-10-2007.html

  17. Example: Training Developers and Informatics teams • 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. Patients • The Patient Advocates are in the process of producing a 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: • Work with SMEs to identify the final use case set from a CTMS point of view. • Work with the community to complete existing use cases (~30). BAM Integration: • Continue working with the Development, BRIDG and Enterprise Services Teams on integration and alignment. Expansion of BAM: • Life Sciences, Imaging, Population Science, Patients, etc.

  19. Acknowledgements 1Scott Hunicke-Smith PhD, University of Texas Austin 2Sharon Elcombe – CTMS SME, Mayo Clinic 3Bob Morrell – CTMS SME, Wake Forrest 4Gene Kraus, Subject Matter Expert, Essex Management Santosh Yoshi– CBIIT Enterprise Services, Ekagra Software Paul Davis – CBIIT Analyst, Essex Management

  20. Questions

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

  22. 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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