1. CTRP 3.9 Planning 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) 9/18/122

3. SCHEDULE REVIEW 9/18/123

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. 9/18/124

5. Proposed 3.9 Schedule (Timeline) Development Starts Feature Freeze/Release Candidate 1 QA Sign Off Security Sign Off 3.15.13 3.9 Release Date 3/29/13 12.28.122.14.138.24.12 CTRO User Testing User Guides Reviewed Proposed Schedule – Not Finalized 9/18/125 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 9 two week iterations 18 weeks (60%) Development 12 weeks (40%) QA, STAGE, Security 3.9m13.9m23.9m3 3.9rc1 …

6. The Development Phase 9 two-week iterations planned IterationDatesOutput of Iteration 1 - 3.9 Milestone 18/24 – 9/73.9M1 2 - 3.9 Milestone 29/10 – 9/213.9M2 3 - 3.9 Milestone 39/24 – 10/53.9M3 4 - 3.9 Milestone 410/8 – 10/193.9M4 5 - 3.9 Milestone 510/22 – 11/23.9M5 6 - 3.9 Milestone 611/5 – 11/163.9M6 7 - 3.9 Milestone 711/19 – 11/303.9M7 8 - 3.9 Milestone 812/3 – 12/143.9M8 9 – 3.9 Milestone 912/17 – 12/283.9 Release Candidate 1 9/18/126 Proposed Schedule – Not Finalized

7. Schedule – List of Major Milestones Development8/24 to 12/28About 18 wks budgeted Coding8/24 to 12/28Nine 2wk iterations Feature Freeze12/28Team delivers 3.9 release candidate 1 to QA Team QA1/3 to 2/156 Weeks Total Budgeted Testing of RCs by QA1/3 – 1/25Approx. 3 weeks budgeted User Guides - drafts reviewed1/8 – 2/14Approx. 5 weeks budgeted CTRO User Testing1/10 – 1/17Exact dates/env to be determined Blocker/Critical Bugs Fixed1/3 – 1/25Team prepares add'l RCs as needed Code Freeze1/25No code changes after this date Regression Testing1/28 – 2/8Approx. 2 weeks budgeted QA Acceptance2/14Approx. 1 week budgeted to get formal signoff STAGE2/15 to 3/154 weeks budgeted Appscans on STAGE2/15 – 3/15 Security Team Sign Off3/15 PRODUCTION3/18 to 3/292 weeks budgeted from Security Team Signoff 3.9 Deployed to PRODBy 3/29/13 9/18/127 Proposed Schedule – Not Finalized

8. SCOPE REVIEW 9/18/128

9. List of Top Priorities for 3.9 (As previously agreed to based on prior planning sessions) 1.Adding support for Non-Interventional Trials (Sulekha) 2.Automating nightly submission of NCI-Sponsored and Managed Trials from CTRP to ClinicalTrials.gov (Farhan) 3.Ability for internal NCI users to generate a complete and accurate Summary 4 Report (Charles) 4.Additional enhancements to Biomarkers (Farhan) 5.Additional enhancements to Accruals (Farhan) 6.Expand Data Warehouse solution to include Accruals (Sulekha) 7.PO Curation Tool Enhancements and Data Clean Up (Sulekha and Charles) 8.Improvements to PA Inbox (Charles) 9.Replace CTRO's reliance on Access-Based Tracking Sheet (Charles) 10.Getting RSS to submit IRB documents via trial registration service (Farhan) 11.Updated look and feel for Registry (Farhan) 12.And … if time permits … other improvements to PA and Registry 9/18/129

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. 9/18/1210 Jira IDDescription PO-5453Registry and PA: 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 9/18/1211

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 9/18/1212

13. 4. Biomarkers Lead: Farhan Analysis is in Progress Coding to begin in Iteration 2 or when ready Table below lists potential items 9/25/1213 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 14 Ranked List – from 9/20 9/25/12

15. 6. Data Warehouse – Accrual Tables PO-5445Data Warehouse - Accrual - Please create DW_STUDY_SITE_ACCRUAL_ACCESS and populate the data PO-5446Data Warehouse - Accrual - Please create DW_STUDY_SITES_ACCRUAL_DETAILS and populate the data PO-5447Data Warehouse - Accrual - Please create DW_STUDY_ACCRUAL_COUNT and populate the data PO-5448Data Warehouse - Accrual - Please create DW_ACCRUAL_BATCH_SUBMISSION and populate the data Lead: Sulekha Key Developer: Hugh Analysis Complete. Coding in progress/scheduled for Iteration 2 9/18/1215

16. 7. PO Curation Lead: Sulekha and Charles Analysis in Progress. Coding in progress/scheduled for Iteration 4 9/18/1216

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 179/18/12

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 189/18/12

19. PO-Curation (Cont'd) Jira IDDescription PO-5475PO-Curation- Process CRs with same address as Current Organization Address PO-5494PO-Curation-Process CRs with same address as other CRs within same Organization PO-5495PO-Curation- Create a Report with Valid Organization CRs for Manual Review PO-5496PO-Curation-CRs Report Review Response Processing PO-5497PO-Curation-Organization Role Curation 199/18/12

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 9/18/1220

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. 9/18/1221

22. 11. Registry - UI Redesign 9/18/1222 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 9/18/1223

24. Example: Preliminary Mockup of Register Trial Page Google like auto completer for Organization and Person fields. 9/18/1224

25. Early Draft Mockups – Possible new logos for CTRP application 9/18/1225

26. 12. Some Additional Registration Enhancements (under consideration) IDDescription PO-5424Allow multiple organization selection for Summary 4 Funding Sponsor PO-2846Only applicable Orgs should be displayed in Registry Search PO-2846Remove ability for users to create new organizations in Registry PO-5132Association between submitting org and trial should not be tied to a person PO-4801A trial in CTRP should be able to have multiple Lead Organizations PO-4877Track users' annual reviews and updates to their trials PO-4603Allow sites to submit amendments for trials even while prior amendment is still being reviewed by CTRO PO-4059Trial Registration Service - enable updates and amendments using CTEP and other trial identifiers PO-3875Bring Registry UI in sync with the Service – add PurposeCodeAddtionalQualifier field to the UI PO-2718Expand Organizational Access feature in Registry so it can work across Organizations It may not be possible to complete all of these in 3.9. Are any of these MUST HAVES? 9/18/1226

27. Some additional PA Enhancements (under consideration) IDDescription PO-5454Make Arm Description field mandatory/part of validation in PA -- THIS IS DONE ALREADY. PO-5422Add "Other Pre-specified" Outcome Measure classification PO-5479Capture target enrollment on Industrial (abbreviated) trials PO-3393Highlight TSR and XML differences and add note about differences in email that system sends with TSR and XML PO-3403TSR: Consider flagging the data elements in the TSR which will be included in the ct.gov xml file PO-4955Add "contact backup" field to participating site fields to CTRP (This field exists in ClinicalTrials.gov) -- Request from FHCRC PO-4954Add "overall official" field to CTRP. (This field exists in ClinicalTrials.gov) – Request from FHCRC PO-1961Allow ctro to enter/select multiple keywords per trial PO-4642Capture a new data element for Complete trials i.e. when a PI at any given site is the author of the trial PO-2430Add new functionality for setting-up list of TSR senders PO-3398Eligibility Criteria: add cut and paste function for an eligibility criteria 9/18/1227 It may not be possible to complete all of these in 3.9. Are any of these MUST HAVES?

28. Dates for Freezing Requirements ItemLead Analyst Analysis Should Be Finalized By Development to Occur In Following Iterations 1. Non-Interventional TrialsSulekhaEnd of Iteration 2 (9/21)3, 4 2. Automated nightly update between CTRP and CT.gov for NCI-Sponsored Trials FarhanEnd of Iteration 3 (10/5)4, 5, 6 3. Ability for internal NCI users to generate a complete and accurate Summary 4 Report. CharlesEnd of Iteration 4 (10/19)5, 6, 7, 8, 9 4. Biomarker EnhancementsFarhanEnd of Iteration 2 (9/21)3, 4 5. Accrual EnhancementsFarhanEnd of Iteration 2 (9/21)3, 4, 5 6. Add Accruals to DW solutionSulekhaEnd of Iteration 1 (9/7)2 7. PO CurationSulekha and Charles End of Iteration 4 (10/19)4, 5, 6, 7, 8 8&9. Improvements to PA Inbox and Search to better match CTRO's workflow and process CharlesEnd of Iteration 2 (9/21)3, 4, 5 10. RSS submit IRB documents to CTRP via serviceFarhanEnd of Iteration 4 (10/19)-- 11. Updated look and feel for RegistryFarhanEnd of Iteration 4 (10/19) 5, 6 Bug Fixes --N/A1, 2, 3, 4, 5, 6, 7, 8, 9 Production SupportN/A 1, 2, 3, 4, 5, 6, 7, 8, 9 9/18/1228

29. ROADMAP REVIEW 9/18/1229

30. A Look Ahead 3.8.1 (Fall 2012)3.9 (Spring 2013)3.10 (Fall 2013) Accruals – Major Improvements to processing logic and performance Non-interventional Trials CTRP/NLM: Nightly Synch to CTRP from ClinicalTrials.gov & other trials (Path #11) Assorted PA Improvements PO Reorg Enable reporting for cancer community Assorted Registry Improvements Summary 4 – Internal NCI users NCi Thesaurus. Change source of termiology from PDQ to NCI Thesaurus. (Path #20) Accrual Enhancements Integrate with Grants System (PO-2033) (Path #22) PO Curation Tool Enhancements Integrate with IRB System (OHRP) (PO-2041) (Path #23) Automated update of NCI Sponsored trials in PRS from CTRP (Path #12) Integrate with CTEP ESYS to obtain full protocol data set. (Path #7) ) PA Inbox enhancements Audit Trail history screens Replace CTRO's reliance on Access Based Tracking Sheet Assorted Biomarker enhancements DW to include Accruals data New UI for Registry IRB document submissions from RSS (Path #3) 9/18/1230

31. 9/18/1231 Systems Integration Slide for Reference – Before 3.9 4 4 14 18 13 10 8 8 16 12

32. 9/18/1232 Systems Integration Slide for Reference – After 3.9 4 4 14 18 13 10 8 8 16 12 3 3 6 6

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 9/18/1233

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 9/18/1234

35. END 9/18/1235

36. EXTRA SLIDES 9/18/1236