1. CTRP User Call April 3, 2013 Gene Kraus CTRP Program Director

2. Agenda Welcome CTRP Program Updates – Gene Kraus, CTRP Demo of CTRP 3.9 - Charles Yaghmour, CBIIT

3. CTRP Program Updates 6 Month Progress Reports Reporting to CTRP on Trial Funding Cancer Center Outreach Calls Reminder about Using the CTRP Upload for CT.gov CTRP Supplements

4. 6-month CTRP Progress Reports FY12 Supplements were released in September, 2012 6-month progress reports due March-April 2013 Progress reports should contain the cancer centers status on the 6 tasks outlined in the supplement -Registration of all Interventional Trials -Submission of all Amendments and Updates -Submission of quarterly patient accrual information -Communication between NCI CTRP and Cancer Centers -Inform NCI of any new CTRP related SOPs -Submission of 6-month and year end Progress reports

5. Reporting of Trial Funding in CTRP Gathering the funding information in CTRP on trials helps NCI better understand the funding levels of various disease types and helps leadership evaluate future funding needs CTRP requires that all trial funding be reported as part of your trial registration and updates Limitations of the system Funding should include any NIH funding associate with the clinical trial and should include the CCSG grant as well as any other funding e.g. RO1, NO1, etc.

6. Cancer Center Outreach Calls CTRP Program Director has been conducting 1-on-1 Outreach Calls for 6 months now. A few centers left to reach out too. Responses to the calls have been very positive Many centers still need to return updated data sheets or let us know they have updated their data within the system Centers wishing any Updated Reports on their trials in CTRP may submit a request to: NCICTRO@mail.nih.gov and I will generate current reports.NCICTRO@mail.nih.gov

7. Review of Upload from CTRP to CT.gov Summary from the Feb. User Call

8. Benefits of Using the CTRP Upload Feature Makes registering, updating, and amending trials quick and easy No need to review XML No need to log into system at both ends, handle XML file, etc. -- just log into PRS and enter a few fields More secure than manual upload method and preferred by NLM -Additional data validation checks are included with this upload method Consistency checking of identifiers: NCI ID, Unique Protocol ID (Lead Organization ID), which helps prevent duplicate registration

9. Benefits of Using the CTRP Upload Feature (Con’t) Handling of XML file increases chances of file version confusion/mistakes. Using direct transfer eliminates this risk Automatic PRS Record Log entry records transfer of information from CTRP Option to update location (site) data only from CTRP. Detailed help page

10. Demo Summary CTRP Upload feature is more secure, reduces errors and duplicate registrations, and is more time efficient. Be sure to include your PRS Org name in your account on the NCI CTRP Registration Site to ensure successful upload in ClinicalTrials.gov. When using the ClinicalTrials.gov Protocol Registration System (PRS) -Review trial IDs -Enter user name and password -Review and Release

11. New CTRP Supplement Funding CTRP is finalizing the latest Supplement Award Announcement Supplement announcement is expected to be released on April 15, 2013 to the Center Directors I will send a copy of the Supplement Announcement to the CTRP contacts at the NCI designated centers Detailed discussion of the CTRP Supplement will be handled on the May 1 st CTRP User call. If you have specific Supplement questions you would like to have addressed on the May call, please send them to me at NCICTRO@mail.nih.govNCICTRO@mail.nih.gov

12. Upload Demo from NCI CTRP 3.9

13. Summary 6 Month Progress Reports Reporting to CTRP on Trial Funding Cancer Center Outreach Calls Reminder about Using the CTRP Upload for CT.gov CTRP Supplements Enjoy the new CTRP v 3.9 Comments/ Question please email NCICTRO@mail.nih.gov NCICTRO@mail.nih.gov

14. Thank You