caBIG ® Clinical Information Suite Stakeholder Management (SHM) Engagement Model and Plan

1. caBIG® Clinical Information Suite Stakeholder Management (SHM)Engagement Model and Plan

2. Project Scope • NCI is developing a series of software modules (referred to as “capabilities”) collectively known as the caBIG® Clinical Information Suite: • Modules will be based on the CORE specifications and the expressed needs of the NCI community • They will integrate with EHRs to deliver functionality and interoperability useful to the practicing oncologist • They will support the specific oncology-related data collection needs of practicing oncologists, and build the “bridge” between clinical care and research • They will leverage NCI’s investment in a scalable services-based infrastructure • They will include both clinical (collecting data) and administrative (managing the trial) functionality, all available under a non-viral license for use by vendors and others in the community

3. Project Purpose To support the ambulatory oncology clinical care communities and open-source and commercial software vendors by delivering a series of highly configurable modular business capabilities and specifications while meeting the ARRA/HITECH meaningful use requirements. These capabilities will • Be highly modular and configurable to address a wide range of clinical settings via workflow, user interface and semantics; • Position users for effective integration with other clinical, administrative and research systems; • Leverage existing HIT standards and extend these standards from an oncology perspective where appropriate; and • Be released with a full set of specifications that can be used by vendors and implementers to leverage all or portions of the project deliverables.

4. Clinical Information Suite Goals • Architectural Adoption by Industry: Software solution vendor(s) consumption of platform independent caBIG® Clinical Information Suite specifications in the development / extension of their product suite. • Measure of success: At least 1 service specification being utilized by industry to develop production viable functionality within their product. • Solution Adoption through the Open Health Tools (OHT) Community: Business Capabilities and/or Reference Implementation consumption by the OHT (open health tools) community to integrate and/or repackage for the health IT market. • Measure of success: At least 1 fully specified and developed business capability consumed by the open source community and/or being implemented as a production implementation by the open source community vendors • Clinical Community Adoption: One or more Business Capabilities and/or the full Reference Implementation (RI) being used in a daily production manner at ‘in scope’ early adopter site(s). • Measure of success: One or more fully specified and developed business capabilities in production use within a clinical care setting within one or more National Community Cancer Center Program sites. Target Goals (One or more of these goals by close of project)

5. High Value Business Capabilities by Type Being Developed Supporting Outcomes Vision These high value capabilities are not in priority order

6. Supporting & Commodity Capabilities caBIG® Clinical Information Suite will design and build Capabilities Well understood in Industry (Built by others) caBIG® Clinical Information Suite will interface

7. SHM Mission • To engage all Stakeholders and; • Ensure overall project adoption by clinical, vendor and research communities across Ambulatory Oncology Care • Ensure involvement of these groups in the caBIG® Clinical Information Suite projects activities and decisions • Recognize those Stakeholders that can affect or may be affected by associated activities and decision making processes • Stakeholder Management representstheCommon Voice to all Stakeholders.

8. SHM Objectives Focus on core Stakeholder engagement processes Establish effective and efficient processes to involve Stakeholders in the broader oncology care community project activities and decisions Influence project success and vision through clear understanding of our customers and their needs Frequent and direct contact with key Stakeholders Assure that all Stakeholders have an opportunity to review and provide feedback on specifications and software components Bring all Stakeholders along in a meaningful way

9. SHM Primary Role Interact directly with project teams to ensure all engagement activities are coordinated across all streams Provide a Common Voice to all Stakeholders Obtain viewpoints, design considerations and consensus on the overall project scope and goals Listen to and respect Stakeholder views Communicate appropriate Stakeholder feedback to adjust project positioning, trajectory and potentially content

10. SHM Primary Role (cont.) • Lead the roll-out of the broader engagement model and plan with all Stakeholder groups • Deployment and Analysis teams will lead the Stakeholder interface when the purpose of the particular engagement has a specific outcome. SHM will then collaborate and advise • Lead all the external communications activities • Communicate potential impacts on the project and provide feedback to all project streams

11. Formal Stakeholder Groups and Processes • NCCCP Implementers Group • Vendor Engagement • Domain Expert / SME Team • Stakeholder Expert Group (SEG) • Iteration and Release Review Group • NCI Division and Center Engagement • Generalized Artifact Review and Endorsement Process • Standards Community Engagement

12. Project Scope • NCI is developing a series of software modules (referred to as “capabilities”) collectively known as the caBIG® Clinical Information Suite: • Modules will be based on the CORE specifications and the expressed needs of the NCI community • They will integrate with EHRs to deliver functionality and interoperability useful to the practicing oncologist • They will support the specific oncology-related data collection needs of practicing oncologists, and build the “bridge” between clinical care and research • They will leverage NCI’s investment in a scalable services-based infrastructure • They will include both clinical (collecting data) and administrative (managing the trial) functionality, all available under a non-viral license for use by vendors and others in the community

13. “Project 18” Sites Outreach • Helen & Harry Gray Cancer Center, Hartford Hospital - Hartford, Connecticut • Helen F. Graham Cancer Center, Christiana Care - Newark, DE • The Cancer Institute, St. Joseph Medical Center - Towson, MD • Billings Clinical Cancer Center – Billings, MT • The Center for Cancer Prevention and Treatment at St. Joseph Hospital, Orange, CA

14. Vendor Outreach • Various activities to explicitly reach out the vendor community, including specific presentations and meetings, likely aligned with other conference / meetings where relevant vendors are likely to be present. • Varian • Cerner • Eclipsys / Allscripts • Tolven • Other Cancer Center EHR Vendors

15. Domain Experts/Subject Matter Experts Group • The DE Team is a core part of the overall project team providing clinical and business expertise; however, it is called out as a separate group since members will provide perspectives for certain stakeholder groups. • Fully embedded into the project via the analysis team. They provide advise and deliverable vetting , use cases, business capabilities.

16. Stakeholder Expert Group • A Project Team assembled to review and endorse the Scope & Vision document - with particular focus on Business Capability prioritization • The group will also provide broad perspectives across stakeholders regarding overall software development scope, vision and business capabilities contemplated for the various releases • Invited Volunteers based on stakeholder category coverage.

17. Business Capability Roadmap (Candidate Capabilities under Consideration) High-Value Modular Business Capabilities in Bold

18. caBIG Clinical Information SuiteOrganization Chart

19. caBIG Clinical Information SuiteOrganization Chart

20. Meet the Stakeholder Management Team Tim Kevin Gene BILL Sam Corinne John