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CTRP 3.9 Planning Meeting

CTRP 3.9 Planning Meeting. 09.18.12. Agenda. Review the Schedule for CTRP 3.9 (5 min) Review Top Priorities and Major Work Planned for CTRP 3.9 (50 min) Review the Roadmap: Quick Look Ahead to CTRP 3.10 (5 min). Schedule Review. About the Dates.

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CTRP 3.9 Planning Meeting

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  1. CTRP 3.9Planning Meeting 09.18.12

  2. Agenda • Review the Schedule for CTRP 3.9 (5 min) • Review Top Priorities and Major Work Planned for CTRP 3.9 (50 min) • Review the Roadmap: Quick Look Ahead to CTRP 3.10 (5 min)

  3. Schedule Review

  4. About the Dates • The dates presented here seek to take into consideration: • Priorities for 3.9 based on the CTRP roadmap. • Size and LOEs of the proposed enhancements for 3.9. • Accommodating the NCI Systems blackout dates due to the data center migration and the end of the year/holidays. • The schedule has not yet been finalized or approved.

  5. Proposed 3.9 Schedule(Timeline) Feature Freeze/Release Candidate 1 Development Starts QA Sign Off Security Sign Off … 3.9rc1 3.9m1 3.9m2 3.9m3 2 3 4 5 6 7 8 9 1 3.9 Release Date 3/29/13 9 two week iterations 8.24.12 12.28.12 2.14.13 3.15.13 18 weeks (60%) Development 12 weeks (40%) QA, STAGE, Security User Guides Reviewed CTRO User Testing Proposed Schedule – Not Finalized

  6. The Development Phase9 two-week iterations planned Proposed Schedule – Not Finalized

  7. Schedule – List of Major Milestones Proposed Schedule – Not Finalized

  8. Scope Review

  9. List of Top Priorities for 3.9(As previously agreed to based on prior planning sessions) • Adding support for Non-Interventional Trials (Sulekha) • Automating nightly submission of NCI-Sponsored and Managed Trials from CTRP to ClinicalTrials.gov (Farhan) • Ability for internal NCI users to generate a complete and accurate Summary 4 Report (Charles) • Additional enhancements to Biomarkers (Farhan) • Additional enhancements to Accruals (Farhan) • Expand Data Warehouse solution to include Accruals (Sulekha) • PO Curation Tool Enhancements and Data Clean Up (Sulekha and Charles) • Improvements to PA Inbox (Charles) • Replace CTRO's reliance on Access-Based Tracking Sheet (Charles) • Getting RSS to submit IRB documents via trial registration service (Farhan) • Updated look and feel for Registry (Farhan) • And … if time permits … other improvements to PA and Registry

  10. 1. Non-Interventional Trials • This is the #1 Ranked Priority for 3.9 • Lead: Sulekha • Analysis is in progress. Should be ready for implementation soon. • Coding shedule to start in Iteration 3. • Registry CTRP->Registry application should support registration of Non- interventional trials. • PA CTRP->PA should support abstraction of Non-interventional trials.

  11. 2. CTRP to ClinicalTrials.gov • Automating nightly submission of NCI-Sponsored and Managed Trials from CTRP to ClinicalTrials.gov • Lead: Farhan • Coding to start in Iteration 4

  12. 3. Summary 4 Report • Lead: Charles • Analysis is in progress. • Dependent on Accruals and understanding changes needed to how we manage organizations • Coding to begin in Iteration 4

  13. 4. Biomarkers • Lead: Farhan • Analysis is in Progress • Coding to begin in Iteration 2 or when ready • Table below lists potential items Ranked List – from 9/19

  14. 5. Accruals • Lead: Farhan • Analysis is in Progress • Coding to begin in Iteration 2 or when ready • Table below lists potential items Ranked List – from 9/20

  15. 6. Data Warehouse – Accrual Tables Lead: Sulekha Key Developer: Hugh Analysis Complete. Coding in progress/scheduled for Iteration 2

  16. 7. PO Curation Lead: Sulekha and Charles Analysis in Progress. Coding in progress/scheduled for Iteration 4

  17. PO-Curation (Cont'd) • PO Curation Enhancements: • PO Curation Scripts / Correction Module • Duplicate and Invalid CRs Auto Curation • Report Generation for Manual Review of Valid Organization CRs • CRs Report Review Response Processing • Organization Role Curation • Person Curation

  18. PO-Curation(Cont'd) • PO Curation- Inbox Navigation Improvements • PO Curation - Enhancements to Curation Events Generation • PO Curation - CTEP Org Synch Process Evaluation • PO Curation - CTEP Person Synch Process Evaluation

  19. PO-Curation (Cont'd)

  20. 8 & 9. PA Inbox Enhancements and CTRO Abstraction Tracking Process • Lead: Charles • Analysis in Progress • Introduce “Abstractor Dashboard” for processing trials and amendments: • My trials • Newly submitted trials • In-progress trials (Admin/Scientific Abstraction/QC) • Unreserved trials (Admin/Scientific Abstraction/QC) • Manage site admin requests, including history • View site admin(s) and affiliated person(s) of an org • View trials owned, or submitted, by a person • View RSS daily run reports

  21. 10. RSS to Submit IRB Documents to CTRP RSS team needs to update their system's code so it can use the existing CTRP trial registration service to submit IRB documents to CTRP. RSS team's timetable for this has slipped; they anticipate starting work on this in next couple of months. CTRP development team's role will be to provide support to RSS during testing. During testing, if it is determined that code changes to CTRP are needed, these will be included as part to 3.9.

  22. 11. Registry - UI Redesign • Lead Analyst: Farhan • UI Engineer: Ben Trayhnam • Status: Early in Design Phase • Finalize Designs: By end of iteration 4, 10/19 • Goal: To give Registry a more fresh, modern look – and in this way make it easier, more pleasant to use. • Cleaner design • Web 2.0 features (like Google-type autocompleters) where appropriate • New CTRP logo? • We do not plan to make major changes to the workflow as part of the UI redesign

  23. Example: Mockup of Search Page

  24. Example: Preliminary Mockup of Register Trial Page Google like auto completer for Organization and Person fields.

  25. Early Draft Mockups – Possible new logos for CTRP application

  26. 12. Some Additional Registration Enhancements(under consideration) It may not be possible to complete all of these in 3.9. Are any of these MUST HAVES?

  27. Some additional PA Enhancements(under consideration) It may not be possible to complete all of these in 3.9. Are any of these MUST HAVES?

  28. Dates for Freezing Requirements

  29. Roadmap Review

  30. A Look Ahead

  31. Systems Integration Slide for Reference – Before 3.9 16 14 4 8 18 13 12 10

  32. Systems Integration Slide for Reference – After 3.9 16 3 14 4 6 8 18 13 12 12 10

  33. AFTER 3.9 – THESE ARE THE HIGH-LEVEL ITEMS FROM ROADMAP THAT WILL BE COMPLETED# • Path 1: Responsible Party or Cancer Center sends New Trial or Amendment to CTEP/DCP PIO • Path 2: Participating Sites send updates to CTSU RSS • Path 3: CTSU RSS provides Trial IRB data to CTRP using CTRP Trial Registration Service • Path 4: CTSU RSS sends participating site information/updates to CTRP using CTRP Participating Site service • Path 5: CTEP/DCP PIO sends New Trial and Amendments to CTRP (via email)Path 7: CTRP to get protocol abstraction data from CTEP ESYS for CTEP/DCP Trials • Path 6: CTRP and ECM share/exchange Person and Organization data* • Path 8: CDUS data can be uploaded into CTRP using the CTRP service, batch mechanism, or web UI • Path 10: CTRP provides nightly dump of Protocol XML files for import by Cancer.gov (PDQ) • Path 12: Automate the nightly update of NCI Sponsored trials in ClinicalTrials.gov with XML from CTRP • Path 13: PRS uploads trial XML from CTRP • Path 14: Responsible Party or Cancer Center registers trial in CTRP via Trial Registration Service • Path 15: CTRP provides Responsible Party or Center with TSR and XML. XML conforms to ClinicalTrials.gov submission requirements • Path 16: Participating Sites are able to add their sites to Industry trials in CTRP** • Path 17: Cancer Centers using Velos are able to submit trial registrations to CTRP via service** • Path 18: Cancer Centers using OnCore are able to submit trial registrations to CTRP via service • Path 19: Responsible Party or Cancer Center submits new trial, update, or amendment to CTRP via UI or Batch ----------------------------------- # = Operational and (from perspective of baseline requirements) completed -- but need for additional improvements or changes may still arise * = Operational, but further integration with CTEP ECM System is envisioned ** = CTRP supports but vendors may not be fully integrated with or utilizing CTRP services yet

  34. AFTER 3.9 – THESE ARE ITEMS FROM FROM ROADMAP THAT WILL STILL REMAIN System Integrations: • Path 7: CTRP to get protocol abstraction data from CTEP ESYS for CTEP/DCP Trials • Path 9: 3rd party CTMS systems can query CTRP for Protocol data • Path 11: ClinicalTrials.gov provides nightly synch and other trials to CTRP • Path 20: CTRP obtains terminology from EVS NCI Thesaurus • Path 21: CTRP integrated with Firebird for exchange of credentialing data • Path 22: CTRP Integrated with Grants system (IMPACTII) • Path 23: CTRP Integrated with IRB system (OHRP) Other: • Implement full Auditing Framework and View History feature in PA • BRIDG Harmonization • Assorted Feature Requests, Enhancements, and Improvements • Bug Fixes • Tech Debt Backlog

  35. END

  36. Extra Slides

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