NCI Clinical Trials Reporting Program CTRP User Meeting

February 1, 2012

Gene KrausCTRP 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 2012- Original submissions 380- Amendments 166

• Metrics January 2009 to date- Original Submissions 5872- Accepted 4910- Abstracted 4184- Trial Summary Report Sent 2713

• Abstraction Verified 695

- Submitted amendments 730

November Review

• User call – November 2nd • Minutes:

https://wiki.nci.nih.gov/display/CTRP/11-02-2011+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 2012. - But, it is to everyone’s advantage to begin submitting

amendments as soon as possible to avoid developing a backlog of amendments.

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• 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 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 ***

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 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: https://trials.nci.nih.gov• CTRP 3.6.1 Registration Site User’s Guide:

https://wiki.nci.nih.gov/display/CTRP/NCI+Clinical+Trials+Reporting+Program+Registration+Site+3.6.1+User%27s+Guide

• CTRP 3.6.1 Trials Registration Batch Upload Templates: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/resources

• Frequently Asked Questions: http://www.cancer.gov/clinic• altrials/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!