Digital Bridge eCR Governance Body Meeting October 13, 2016, 12PM - PowerPoint PPT Presentation

Digital Bridge eCR Governance Body Meeting October 13, 2016, 12PM – 1PM Eastern Facilitator – John Lumpkin Conference Line: Dial: 1-866-774-4804 Code: 988-724-4096

Agenda Topic Contents Duration Meeting Start • Roll call • Agenda review 5 minutes • Basecamp Project timeline • Review project timeline, milestones and 5 minutes deliverables Communications materials • Review and discuss communications materials to 10 minutes date Technical Architecture Workgroup • Review and discuss charge and timeline for Technical Architecture Workgroup 15 minutes • VOTE: Technical Architecture charge Requirements materials • Review draft business process matrix 20 minutes Next steps • Next steps • Next Governance Body meeting – October 27, 2016 5 minutes 12PM-1PM ET 2

Digital Bridge eCR Project Timeline – Proposed 2016 Q3 2016 Q4 2017 Q1 2017 Q2 2017 Q3 2017 Q4 2018 & Beyond Communications Plan Refine Charter Evolve, Extend Information Governance Coordinate Workgroups (WGs) and Engage Stakeholders Exchange Capabilities Charter Identify New Use Cases Develop Project Plan Functional Requirements Defined Requirements WG Inventory Technical Assets Document Lessons Learned Technical Provide Technical Guidance and Monitor eCR Implementations Arch WG Technical Approach Defined Sustainability Plan Preliminary Sustainability Plan Sustainability Articulate Business Case for eCR WG Measure Success Success Metrics Defined Recommendations Legal & Regulatory Clarify eCR legal, regulatory issues WG Model BAAs, DUAs Onboard eCRs eCR Implementations Ongoing submission of eCRs Sites Selected Declare MU eCR Readiness MU eCR Deadline

Communications 4

Communications 5

Technical Architecture Work Group 6

Technical Architecture Work Group Charge • Review eCR business process description (Matrix, Task Flow Diagram) developed by the Requirements Work Group and approved by the Digital Bridge Governance body • Review eCR functional requirements developed by the Requirements Work Group and approved by the Digital Bridge Governance body • Review inventory of existing technical components and artifacts supporting eCR developed by the Requirements Work Group and approved by the Digital Bridge Governance body • Develop eCR technical requirements for review and approval by the Digital Bridge Governance body • Develop recommended technical architecture diagram and accompanying technical process workflow description for review and approval by the Digital Bridge Governance Body 7

Technical Architecture Work Group Deliverables Should Address: • Technical architecture for delivering electronic case reports • Recommendations for how to implement the technical architecture at each implementation site • Assumptions for any technical requirements, including the use of any specific technical standards, specific tools/shared services and their availability for use in implementation sites 8

Motion to Approve Technical Architecture Workgroup Charge 10

Requirements Materials Review Electronic Case Reporting Business Process Matrix Tasks • Business Process Matrix approval 11

Next Steps • By 10/21, review and provide feedback on today’s meeting minutes • Next Meetings: − Governance Body: Thursday, 10/27 12PM-1PM ET − Governance Body: Thursday, 11/10 12PM-1PM ET 12