NCI Clinical Trials Reporting Program CTRP User Meeting July 6, 2011 Gene Kraus CTRP Program Director

Status update -CTRO Metrics -June Review CTRP Website Revision Bug Notification System Release of CTRP Specifications Grant Supplement Release Agenda

CTRO Metrics Metrics for June Original submissions252 -Amendments 26 Metrics January 2009 to date -Original Submissions4306 -Accepted3811 -Submitted amendments411

Quarterly Summary of Submissions to CTRP

June review User call – June 1 st Minutes: CTRP+Site+Minuteshttps://wiki.nci.nih.gov/display/CTRP/ CTRP+Site+Minutes CTRO submitted questions/comments Updates and IRB error message Accrual Reporting CTRP 3.5 target released date is 07/28/11 CTRP Registration Webinar

CTRP Website

CTRP Webpage

Bug Notification System CTRO is working with the developers to implement a new Bug Notification System. Bug problems that appear to affect more than a single user will be posted to the listserv with a heading of CTRP Bug Notification. We expect the number of notifications to be minimal and can be easily deleted (based on the heading) for those who do not wish to view the notification.

Registration Specifications

The NCI’s Center for Biomedical Informatics and Information Technology (CBIIT) along with the Coordinating Center for Clinical Trials (CCCT) has posted for public consumption the Clinical Trial Reporting Program (CTRP) trial registration specifications. CTRP provides 3 methods for registering trials into its database, single trial submissions, batch submissions and system-to-system integration via the trial registration service. The specifications for each of these methods can be found at: ice+Documentation ice+Documentation

Trial Registration Service Documentation

Administrative Supplements for NCI- designated Cancer Centers to Support the Registration of Clinical Trial Data into the NCI’s Clinical Trials Reporting Program (CTRP)

CTRP Supplement Announcement CTRP Supplement Award announcements went out to all NCI cancer center directors on June 21, This supplement is intended to provide support for NCI designated Cancer Centers through administrative supplements to P30 Cancer Center Support Grants in the final stages of a national redesign of the cancer clinical trials enterprise. Supplements are for 1 yr The total supplemental budget should not exceed $75,000 (total costs). Funding will be based on the requirements spelled out in the notice

What’s the catch

Tasks to be completed by the Center within 1 year Register with CTRP all interventional clinical trials, including externally peer- reviewed, institutional, and industrial trials that were open to accrual as of January 1, 2009 or later at your cancer center. Beginning March, 2012, submit trial amendments and updates within the guidelines specified. Develop a process for beginning to submit quarterly patient accrual information. Communication between the NCI CTRP and the Cancer Centers -Submit comments on issues and problems -Provide feedback to CTRP on documentation and training materials -Participate in regular teleconferences (like this call) Inform NCI of any updates to site-specific Standard Operating Procedures (SOPs), or staff regarding CTRP Submit a Progress Report to the CTRP program at 6 months following receipt of the supplement award as well as at the conclusion of the 1 year award. Participate in discussion with the NCI to assess the feasibility and develop cancer community requirements for reporting non-interventional trials.

Supplement Review Criteria All proposals will be reviewed for merit by a committee of NCI staff having expertise in Cancer Centers and CTRP functions. The 4 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.

4 points of the Summary of the Project -Description of the current clinical and information technology and any obstacles that might be encountered reporting to CTRP ongoing cancer clinical trial registrations, amendments or updates, and patient accrual for your institution. -An estimate of the number of new cancer clinical trials that will be registered in CTRP during the funding period. -Timeline for implementation: An estimate regarding the initiation of registration and the proposed timeline for completing registration of existing trials, amendments and updates as well as a proposed process for patient accrual reporting. -Provide current progress/utilization of any previous supplemental funding on registration of the centers clinical trials open to accrual as of January 1, 2009 to present.

Key Dates Application Release Date:June 21, 2011 Application Receipt Date: July 22, 2011 Anticipated Start Date:September, 2011

Questions Programmatic: Please contact the NCI Program Director for your P30 CCSG award, telephone number Budget: Please contact the NCI Grants Specialist for your Cancer Center at the phone number indicated on the latest Notice of award. CTRP Related: Contact the CTRO or the CTRP Program Director at:

CTRP User Resources CTRP User meeting minutes: CTRP informational website: -Resources include FAQs, Glossary, and a CTRP User’s Guide CTRP Forum: -Ask questions of the CTRP team and other CTRP users CTRP Developers’ wiki: wiki: – CTRP Users Manage your own subscription: bin/wa.exe?SUBED1=CTRP-USERS-L&A=1https://list.nih.gov/cgi- bin/wa.exe?SUBED1=CTRP-USERS-L&A=1 Registration Specifications All questions/comments: