NCI Clinical Trials Reporting Program CTRP User Meeting

May 2, 2012

Gene KrausCTRP Program Director

• 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

CTRO Metrics

• Metrics for period February 2012 – April 2012- Original submissions 523- Amendments 385

• Metrics January 2009 to date- Original Submissions 7809- Accepted 7089- Abstracted 6261- Trial Summary Report Sent 5667

• Abstraction Verified - Response 1017

- Submitted amendments 1168

February Review

• User call – February 1st. • Update from CBIIT on Enterprise Services for CTRP

Submission• Reminder of Amendment Submissions• CTRP Supplement Award 6 month Progress Reports• Update on NLM Presentation

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.

CTRP 2011 Administrative Supplement

6 Month Progress Reports

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

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.

Amendments/Updates Reporting

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. (

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.

*** Please send additional intermediate change documents to CTRO (NCICTRO@mail.nih.gov) clearly indicating the trial ***

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.

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)

2) Batch Upload Submission (http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources)

3) Web Services (http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources)

CTRP Registration/Amendment Batch Submission DEMO

Andrea JacksonFarhan Khan

CTRP Administrative Supplements

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.

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

CTRP Useful Links

• CTRP Registration Site: https://trials.nci.nih.gov• CTRP 3.7 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• Frequently Asked Questions:

http://www.cancer.gov/clinicaltrials/conducting/ncictrp/faqs • CTRP Users Forum: https://cabig-kc.nci.nih.gov/CTMS/forums/ • CTRP User listserv: 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

Questions!