NCI Clinical Trials Reporting Program CTRP User Meeting February 1, 2012 Gene Kraus CTRP Program Director

Status update -CTRO Metrics -November Review Update from CBIIT on Enterprise Services for CTRP Submissions Reminder of Amendment submissions CTRP Supplement Award 6 month Progress Reports Update from NLM Request for topics for “future” User Calls Agenda

CTRO Metrics Metrics for period November 2011 – January Original submissions380 -Amendments166 Metrics January 2009 to date -Original Submissions5872 -Accepted4910 -Abstracted4184 -Trial Summary Report Sent2713 Abstraction Verified695 -Submitted amendments730

November Review User call – November 2 nd Minutes: CTRP+Site+Meetinghttps://wiki.nci.nih.gov/display/CTRP/ CTRP+Site+Meeting NLM Presentation “ClinicalTrials.gov – Overview and Implications of Recent PRS Updates” Summary - Amendment call from 10/12/2011 CTRP Account Migration Update Reminders Informed Consent Documents Templates

Update By CBIIT on the Enterprise Services for reporting into CTRP

Amendments/Updates Reporting

Timelines for Reporting Amendments NCI ‐ designated Cancer Centers should develop processes and begin regularly submitting amendments by end of March But, it is to everyone’s advantage to begin submitting amendments as soon as possible to avoid developing a backlog of amendments. - 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. (

Timelines for Reporting Updates Updates: Once each year, the submitter is to provide: -A list of all changes made to the protocol since the last amendment or update was submitted, or -For a study that provides an annual update to the IRB, a copy of this annual update will meet this requirement, or -For centers with an electronic IRB approval system and/or centers that do not have a change memo readily available for submission, a redline and strikeout protocol document showing the changes in the document itself is an acceptable alternative. If no changes were made to the protocol document during the previous 12 months, then the submitter will be asked to confirm that no changes have taken place.

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 CTRO and provide trial ID for access to submit *** Please send additional intermediate change documents to CTRO clearly indicating the trial

Methods for CTRP Trial Amendment Submission Amendments should registered via one of the following three mechanisms: 1) CTRP Registration Web Site ( 2) Batch Upload Submission ( 3) Web Services (

CTRP Administrative Supplement 6 Month Progress Reports

CTRP Progress Reports The CTRP administrative supplement Award asks 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

CTRP Administrative Supplement Tasks 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.

Update from NLM We have received feedback from a few institutions that they actually prefer the new structure. We are working with the CTRP IT folks on a more convenient way to move the data from the NCI CTRP system into our system. We expect this to be deployed in the next month or two. We will continue to work on ways to simplify and streamline the process. If people have specific suggestions, please forward them to us at NLM.

CTRP Useful Links CTRP Registration Site: CTRP Registration Site User’s Guide: gistration+Site User%27s+Guide gistration+Site User%27s+Guide CTRP Trials Registration Batch Upload Templates: Frequently Asked Questions: altrials/conducting/ncictrp/faqs CTRP Users Forum: CTRP User listserv: CTRP Services Documentation and Integration Instructions:

Questions!