1. NCI Clinical Trials Reporting Program CTRP User Meeting May 2, 2012 Gene Kraus CTRP Program Director

2. Status update -Review of February Call Grant information on CTRP submissions 6 month Progress Reports - Reminder Amendment Submissions – Reminder/Details DEMO presentation of Batch Submission for New Trial Registration and Amendments CTRP Supplement Awards Future CTRP User Calls Agenda

3. CTRO Metrics Metrics for period February 2012 – April 2012 -Original submissions523 -Amendments385 Metrics January 2009 to date -Original Submissions7809 -Accepted7089 -Abstracted6261 -Trial Summary Report Sent5667 Abstraction Verified - Response1017 -Submitted amendments1168

4. February Review User call – February 1 st. Update from CBIIT on Enterprise Services for CTRP Submission Reminder of Amendment Submissions CTRP Supplement Award 6 month Progress Reports Update on NLM Presentation

5. Grant Information for CTRP A reminder to centers regarding submission of Trial funding information Need to include any “grant Information” funding a trial being registered in CTRP Goal is to capture any specific funding for the specific trial, but at a minimum, the center grant info should be included if there is no other associated funding.

6. CTRP 2011 Administrative Supplement 6 Month Progress Reports

7. CTRP Progress Reports The CTRP administrative supplement Award released in September 2011 asked that a progress report be submitted 6 months following the award of the Supplement. This would make those reports due by end of March 2012 Thank you to those centers that have submitted. Others, please submit your reports ASAP

8. CTRP Administrative Supplement Tasks to Report Register with CTRP all interventional clinical trials Beginning March, 2012, submit trial amendments and updates Develop a process for beginning to submit quarterly patient accrual Communication between the NCI CTRP and the Cancer Centers Inform NCI of any updates to site-specific Standard Operating Procedures (SOPs), for staff regarding CTRP. Submit a Progress Report to the CTRP program at 6 months Participate in discussion with the NCI to assess the feasibility and develop cancer community requirements for reporting non-interventional trials.

9. Amendments/Updates Reporting

10. Timelines for Reporting Amendments NCI ‐ designated Cancer Centers should have developed processes and begun regularly submitting amendments by end of March 2012. - Going forward, all amendments are to be submitted within 20 days of the approval of the change in the protocol by the institution’s IRB. -An amendment submission is to include all changes to the clinical trial since the original trial registration or last amendment submission. (

11. Reminder of Amendment submissions – Dealing with Backlog Submit the most current protocol document and corresponding change memo** or mocked-up Trial Summary Report (TSR ) via registration. memo sent to the IRB listing these changes will suffice if a change memo is not available If the amend link is not available through registration account, please email CTRO (NCICTRO@mail.nih.gov) and provide trial ID for access to submit amendment.NCICTRO@mail.nih.gov *** Please send additional intermediate change documents to CTRO (NCICTRO@mail.nih.gov) clearly indicating the trial ***NCICTRO@mail.nih.gov

12. Registration of Clinical Trials in CTRP Registration of interventional clinical trials into CTRP is the responsibility of the Cancer Centers and was included as part of the FY10 and FY11 CTRP supplement agreements. Centers are more than welcome, and even encouraged, to work with their individual vendors to facilitate their CTMS for automated submission of registrations and amendments into CTRP Any questions on submission processes for registrations and amendments please contract CTRO and we will work with each center.

13. Methods for CTRP Trial Amendment Submission Amendments should registered via one of the following three mechanisms: 1) CTRP Registration Web Site (https://trials.nci.nih.gov)https://trials.nci.nih.gov 2) Batch Upload Submission (http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources)http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources 3) Web Services (http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources)http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources

14. CTRP Registration/Amendment Batch Submission DEMO Andrea Jackson Farhan Khan

15. CTRP Administrative Supplements

16. 2012-13 Administrative Supplements The NCI is preparing for another round of CTRP administrative supplements to cancer centers P-30 grants for the coming fiscal year. 2012 Administrative Supplement to facilitate trial registration, amendments AND accrual reporting As part of this years application review, the award applications for the next round of supplements will be reviewed for centers compliance with past supplement deliverables, previous funding and the level to which those funds were used to support the submission of their clinical trial registrations and amendments into CTRP. Center funding for this round of supplements is expected to be similar to last years amount.

17. Future Calls CTRP User calls will be moving to a Quarterly Call Schedule Additional calls may be scheduled as news and events happen that require sharing with the Cancer Centers Welcome Topic suggestions for future calls

18. CTRP Useful Links CTRP Registration Site: https://trials.nci.nih.gov https://trials.nci.nih.gov CTRP 3.7 Registration Site User’s Guide: NCI Clinical Trials Reporting Program Registration Site User's Guide NCI Clinical Trials Reporting Program Registration Site User's Guide CTRP 3.7 Trials Registration Batch Upload Templates: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources Frequently Asked Questions: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/faqs http://www.cancer.gov/clinicaltrials/conducting/ncictrp/faqs CTRP Users Forum: https://cabig-kc.nci.nih.gov/CTMS/forums/ https://cabig-kc.nci.nih.gov/CTMS/forums/ CTRP User listserv: https://list.nih.gov/cgi-bin/wa.exe?A0=CTRP-USERS-L https://list.nih.gov/cgi-bin/wa.exe?A0=CTRP-USERS-L CTRP Services Documentation and Integration Instructions: https://wiki.nci.nih.gov/display/CTRP/Trial+Registration+Service+Documentation https://wiki.nci.nih.gov/display/CTRP/Trial+Registration+Service+Documentation

19. Questions!