1. CTRP User Call August 6, 2014 Gene Kraus CTRP Program Director

2. Agenda Welcome CTRP Topics -Viewing the new CTRP 4.0.1 in Older Browsers -Primary Completion Date -CTRP outreach calls to NCI-Designated Cancer Centers Review of Organization in CTRP – Deb Hope Wrap-up

3. Viewing CTRP 4.0.1 in various Web Browsers It has come to our attention that a couple centers may be having difficulty viewing the new CTRP 4.0.1 with Internet Explorer 8 (IE8). -IE8 was released 5 ½ yrs ago. The current version is 11 CTRP 4.0.1 was officially tested by our QA team on IE 9 and 10, Firefox 28, and Chrome 33. For those centers that are still running the much older version of IE, you may need to open CTRP in either Firefox or Chrome.

4. Primary Completion Date Primary Completion Date: The date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected. Whether the clinical study ended according to the protocol or was terminated does not affect this date. -The "estimated primary completion date" is the date that the researchers think will be the primary completion date for the study. -The primary completion date is the term used in ClinicalTrials.gov for "completion date" defined in Section 801 of the Food and Drug Administration Amendments Act of 2007. Primary Completion Date should be specified as -Anticipated: the expected completion date -Actual: the date trial reached PCD

5. Primary Completion Date Is FDAAA Required May not be the same as the study completion date -Final date on which data was (or is expected to be) collected for the primary outcome. Anticipated/Actual Can occur before the trial status reaches Complete Must be updated regularly to maintain an accurate anticipated date Drives the due date for results reporting to ClinicalTrials.gov -12 months after PCD

6. Outreach Calls – Data Table 4 Reviews The CTRP Program Director, in coordination with the Program Director from Office of Cancer Centers is currently reaching out to all NCI Designated Cancer Centers These calls are a “First Pass” at comparing the Data Table 4 information generated from CTRP with the data submitted by the Cancer Centers in their CCSG DT4 reports These calls generally last between 45-60 minutes Draft CTRP DT4 reports are shared with the Cancer Center following the call Centers are asked to review the questions that arise during the review of these draft reports and get back to the CTRP Program Director in 2 weeks with an update on their review of the data presented.

7. Common Issues in CTRP DT4 Reports Trials not registered in CTRP Trials with Closed status in CTRP but reported on DT4 Center not listed as a participating site.

8. Trials not registered in CTRP We review the list of trials not registered in CTRP and determine if these should be registered in CTRP and the best way to get these trials into CTRP

9. Closed Trials in CTRP We Review the list of trials that are listed as Closed in CTRP and try to determine if trial was open at your Cancer Center during time period of Data Table 4 Report. Center will then need to correct the status and status dates for these trials in CTRP

10. Correct Status Date Issues During Verification Users should use change status in registry when: Correcting status dates, Verifying trial data, or When viewing TSRs

11. Trial Verification – Status

12. Center not listed as a Participating Site I Review with the centers a list of trials and work to identify any participating sites that should be included as part of Cancer Center organization To help with this issue, we have a Team that is working with us to help Clean-up the organizational structures of Cancer Centers in CTRP Deb Hope is leading this team and will do a presentation outlining our efforts to date on Cancer Center Organizational Structures in CTRP and next steps.

13. Cancer Center Organization Structure in CTRP Deb Hope, Ph.D., MBA, PMP

14. Organization Overview Review Need for Organization Data clean-up and Harmonization in CTRP Review Organization Families in CTRP Review Plan for Organization Data Clean-up and Harmonization

15. Multiple Stakeholders Organizations in CTRP are part of the trial records for: -NCI-designated Cancer Center trials includes industry-sponsored trials -CTEP-managed trials -DCP-managed trials -Center for Cancer Research (CCR)-managed trials C TRP trial records are used by: -ClinicalTrials.gov

16. Multiple Sources of Organizations Sources of Organizations in CTRP -CTEP Enterprise Core Module (ECM) CTEP ECM is the provider of NCI Organization IDs (CTEP-ID) CTRP and ECM share organization data -Cancer Center Users can request a new organization using the Registry application -Cancer Center 3 rd party software automated accrual loading (e.g. OnCore)

17. Multiple Sources of Organizations Sources of Organizations in CTRP (continued) -Clinical Trials Reporting Office (CTRO) part of the administrative abstraction process −if the protocol document contains a Lead Organization or a Participating Site that is not already an organization in CTRP, a new organization is created -ClinicalTrials.gov imported industrial trials can contain organizations that are new to CTRP

18. Multiple Organizations To Choose From

19. Data Redundancy Having multiple “variants” of an organizations -Makes it challenging to select the correct organization to associate with a trial. -Creates a situation where a single organization could be represented as different organizations on different trials Not all “variants” are redundant -There are organizations within CTRP that may not be directly relevant to Cancer Centers but are needed by the other stakeholders, e.g., CTEP, DCP, CCR

20. Clean-up Requires Cancer Center Input CTRP has a dedicated team of Curators that manage the organizations in the system. Curators need feedback from the Cancer Centers to determine which organizations should to be retained and which should be removed Curators will work with cancer centers individually to determine the need for, and use of, organizations related to their cancer center family that appear to be redundant -Do these organizations represent functionally distinct organizations to a Cancer Center user or can they be consolidated? is it a name permutation? a nickname? alternative name? is it a new name for an existing organization? does it need to be distinct organization in CTRP?

21. Clean-up also involves Data Harmonization with CTEP Curators are also working with CTEP to harmonize Organization with the ECM data set -for example, there are some organizations within CTEP ECM that have been merged with other organizations -these organizations will need to be “merged” in CTRP as well

22. Data Clean-up and Harmonization First phase is to determine the complete set of organizations across all Cancer Center Families that are being retained and removed. Curator “preliminary” analysis: -78 of the ~350 organizations in the complete set of Cancer Center Families are affected -Not all Cancer Centers will require changes When all of the Cancer Centers feedback has been received, curators will create a comprehensive list of all the organizations affected by the data clean up and data harmonization process to share with the Cancer Centers

23. Organization Families in CTRP Cancer Center Organization Families in CTRP -Consist of a set of organizations (and relationships) specified by the Cancer Center One family for each NCI Cancer Center -Are named as specified by the Cancer Center The family is not an organization -Are used in the creation of the CTRP Data Table 4 Report For a trial to be included on the DT4, the organization associated with the trial must be part of the Cancer Center family The relationship determines the column where the accrual counts will be reported in the Data Table 4 report -Can be used to manage access for loading accrual

24. Example Family Mr. & Mrs. G. Benefactor Cancer Center of Notable University

25. Family clean-up may affect other Cancer Centers Although the evaluation of organizations will occur at the family level, the data clean-up has the potential to affect other cancer centers -If your organization is currently the Lead Organization on a Multicenter trial and you have responsibility for loading accrual for that trial, one or more of the participating sites on your trial may be affected by the data clean up

26. Removal of organizations from CTRP “Removing” an existing organization record is accomplished by nullification -Requires two organizations -Acts like a merge - one organization is retained and the other is nullified, the nullified organization will no longer appear in user searches

27. Consequences of Nullification Organization Nullification -Trials and trial-specific registration information associated with the nullified organization is automatically transferred to the retained organization If “N.U. Cancer Center” is nullified into “Notable University Cancer Center” all trials where “N.U. Cancer Center” was a Lead Organization, a Participating Site, or a Sponsor will automatically be updated with “Notable University Cancer Center” −Only changes within CTRP −A Trial Summary Report (TSR) generated after the nullification will have the updated organization information

28. Consequences of Nullification Organization Nullification -Accrual is NOT automatically transferred The CTRP team is investigating several options to try and automate the transfer of accrual from the nullified organizations to the retained organization for the appropriate trials This will address accrual currently in CTRP (legacy accrual) -Accrual loading to trials after the nullification of the organization will require that the Cancer Centers load future accruals to the retained organizations Curators will provide a comprehensive list of all organizations affected (created in Phase 1): −If you had been using Organization X now use Organization Y

29. Next Steps Curators would like to work individually with Cancer Centers over the next month to review the details of the organizations associated with their families -send an email to ncictro @mail.nih.gov ncictro @mail.nih.gov subject line: Family Data Clean-up “Your Cancer Center Name” −Suggest a few convenient times for review -curators will provide a table showing the current state and the proposed state after clean-up Cancer centers can accept the proposed changes or discuss other options -the data clean-up will be coordinated so that is minimally disruptive to your workflow

30. Next Steps The CTRP team is investigating several options to accomplish the transfer of accrual data from the nullified organizations to the retained organization for the appropriate trials When the accrual transfer plan for legacy accrual is complete -curators will nullify the affected orgs en masse -developers will complete the legacy accrual transfer After the organizations are nullified -Cancer Centers will have the list of organizations that should be used for accrual loading

31. Organization in CTRP Questions/Comments

32. In Conclusion Viewing the new CTRP 4.0.1 in Older Browsers Primary Completion Date CTRP outreach calls to NCI-Designated Cancer Centers Review of Organization in CTRP

33. CTRP 4.0.1 – User Guides CTRP User Guides https://wiki.nci.nih.gov/display/CTRPdoc/NCI+Clinical+Trials+Reporting+Program +%28CTRP%29+User%27s+Guides

34. Send questions / topics for future calls

35. Thank You