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caBIG Clinical Trials Suite

caBIG Clinical Trials Suite. Operations and Maintenance Kickoff . Ram Chilukuri. ram.chilukuri@semanticbits.com. I ntroductions Vision and Scope Team Development Methodology Next Steps Deliverable Schedule. Introductions. Vision.

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caBIG Clinical Trials Suite

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  1. caBIG Clinical Trials Suite Operations and Maintenance Kickoff Ram Chilukuri ram.chilukuri@semanticbits.com

  2. Introductions • Vision and Scope • Team • Development Methodology • Next Steps • Deliverable Schedule

  3. Introductions

  4. Vision Perform operations and maintenance in parallel with planned and unplanned enhancements for the caBIG Clinical Trials Suite Final goal is to ensure that through process changes and prioritized enhancements we provide a more stable, easy to use product that more closely aligns with the NCI community requirements

  5. Scope - SOW Tasks • Software Maintenance: defectand enhancement tracking, perform fixes prioritized by the TRB and update codebase, QA support, deployment, and create/update documentation • Operational Support: bug and issue resolution, direct communication with adopters, presentations, F2F meetings, CTMS KC forums and technical guidance • Support the TRB: task prioritization, provide detailed assessment for reported issues, their impact and severity and LOEs fixing them • Enhancements for 2TRANSCEND: architecture and design, iHub enhancements, and caAERS enhancements • Enhancements to Support caAERS to AdEERS Integration: integrate caAERS with NCI CTEP web services • Support for Open Source Model: analyze migration suitability, mediate barriers, and create suitability report

  6. Organizations

  7. Team While from different organizations, we will work as a cohesive team

  8. Development Methodology • Period of Performance: 1 year • Agile/Scrum • Daily scrums, monthly iterations, product/sprint backlogs • Three releases • Inception/Elaboration (1 month): review Product Backlog with the TRB, finalize the project plan in coordination with the COTR, iteration planning, begin O&M, define use cases, begin enhancements • Construction (2 months): iteration planning, continue analysis, continue O&M, continue enhancements • Transition (1 month): iteration planning, handover for testing, finalize documentation, complete/deploy release

  9. High-level Schedule

  10. Release schedule

  11. Release 1 – February 2012

  12. Release 1 – Key High Level Tasks • Implement Participant Registration integration scenario between caAERS and 2TRANSCEND • Enhancements to Tolven, caAERS and iHub/MirthConnect • Develop architectural baseline for 2TRANSCEND integration • Implement enhancements to caAERS to support 2TRANSCEND • Enhance routine AE capture functionality • Add safety signal analytics and reporting • Collaborate with CTEP and its IT contractor (CTIS) in design and development of web services needed to support new caAERS to AdEERS integration scenarios • Protocol, Agent, Organization, LOV web services • Implement common LAF across all the Suite applications

  13. Release 2 – June 2012

  14. Release 2 – Key High Level Tasks • Implement AE data related integration scenarios between caAERS and 2TRANSCEND • Tolven, iHub/MirthConnect enhancements • Implement caAERS to AdEERS additional integration scenarios • Protocol, Agent, Organization and LOV web services

  15. Release 3 – October 2012

  16. Release 3 – Key High Level Tasks • Pilot enhancements to support 2TRANSCEND with the I-SPY2 trial sites • Pilot caAERS to AdEERS integration enhancements • Refine/Harden 2TRANSCEND and caAERS to AdEERS integration enhancements based on the feedback from pilot sites • Provide support for open source model

  17. Risk Management • Utilization of a Structured Risk Management Matrix • Process: risk identification, qualification, monitoring, mitigation, and resourcing • The risk matrix will be reviewed weekly with the COTR and the PO

  18. Process Enhancements • Single Project Manager to oversee the development team • Ram Chilukuri • Business Analysts dedicated to the Suite • Paul Baumgartner, Sean Whitaker • Consistent involvement of Subject Matter Experts for the Suite • Sharon Elcombe, Bob Annechiarico, Warren Kibbe

  19. Next Steps • Identify the TRB (Due: Today) • Project planning • Update PMP/O&M Plan (12/2/11) • Risk plan (12/2/11) • Create project backlog for Release 1 (11/11/11) • Sprint planning • Create sprint backlog (Due: 11/11/11) • Schedule meetings (Due: 11/11/11) • Scrums, PO/COTR status, TRB review, sprint planning, etc. • Setup JIRA (Due: 11/11/11)

  20. Deliverable Schedule

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