1. NCI Clinical Trials Reporting Program CTRP User Meeting June 6, 2012 Gene Kraus CTRP Program Director

2. Introduction Overview of CTRP Administrative Supplements DEMO of CTRP version 3.8 Agenda

3. CTRO Activity Submissions for period May 2012 -Original submissions238 -Amendments191 Submissions January 2009 to date -Original Submissions8057 -Accepted7310 -Abstracted6673 -Amendments1356

4. Reminder: Grant Information for CTRP A reminder to centers regarding submission of Trial funding information Need to include P30 grant and any other NIH grant number fully or partially funding the trial being registered in CTRP

5. CTRP 2012 - 13 Administrative Supplement

6. 2012 Cancer Center Administrative Supplement Purpose: Facilitate trial registration, amendment submission AND accrual reporting  $75,000 maximum amount of request  Award based on past performance Timeline  Notice of award to be released: May 14  Responses due to NCI by: June 22  Notification of Awards: Sept 2012

7. Tasks to be Completed by the Center 1.Completion and ongoing registration in CTRP of all interventional clinical trials, including externally peer-reviewed, institutional, and industrial trials. 2.Ongoing submission of trial amendments to CTRP within 20 days of approval of change in protocol document by institution’s IRB. 3.Submission of quarterly patient accrual information is scheduled to begin September, 2012. -Centers that have received previous supplements should already have developed a plan for the submission of accrual data. 4.Communication between the NCI CTRP and the Cancer Centers 5.Inform NCI of any new site-specific Standard Operating Procedures (SOPs), or any updates to previous SOP’s for staff regarding CTRP operation at the cancer center 6.Submit a Progress Report to the CTRP program at 6 months following receipt of the supplement award

8. Review Criteria All proposals will be reviewed for merit by a committee of NCI staff having expertise in Cancer Centers and CTRP functions. -The 3 points addressed in the “Summary of the Project” section will be included in the review. -Previous Supplement awardees will be reviewed for progress on prior deliverables as well as utilization of previous funds.

9. Administrative Supplement Questions Programmatic: Please contact the NCI Program Director for your P30 CCSG award, telephone number 301.496.8531. Budget: Please contact the NCI Grants Specialist for your Cancer Center at the phone number indicated on the latest Notice of award.

10. DEMO of CTRP Version 3.8

11. May Review User call – May 2 nd Minutes: https://wiki.nci.nih.gov/display/CTRP/05- 02-2012+CTRP+Site+Minuteshttps://wiki.nci.nih.gov/display/CTRP/05- 02-2012+CTRP+Site+Minutes 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

12. 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

13. Questions!