CTRP User Call

May 1, 2013

Gene KrausCTRP Program Director

Agenda

• Welcome

• CTRP Program Updates

• Overview of CTRP Administrative Supplement

CTRP Program Updates

• 6 Month Progress Reports• Reporting to CTRP on Trial Funding• Reminder and new reference about Using the CTRP

Upload for CT.gov• Disease Coding in CTRP• Cancer Center Accrual Reporting• Submitting an amendment while previous submission

is being processed. • Site Admin Authority• Primary Completion Dates • CTRP Administrative Supplements

6-month CTRP Progress Reports

• FY12 Supplements were released in September, 2012• 6-month progress reports were due April 2013 and are

currently under review.• Reminder: 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

• Thanks to those centers that have submitted

Reporting of NIH Funding in CTRP

• Reminder: Please complete the NIH Grant Information on your trials

• CTRP requires that all trial funding be reported as part of your trial registration and updates

• Funding should include any NIH funding associated with the clinical trial and should include funding e.g. R01, U10, N01, P50, etc.

• NCI uses this information for its portfolio management

Reminder of CTRP PRS Upload to CT.gov

• 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

• NLM has put together a very helpful Troubleshooting Guide for upload to CT.gov from CTRP. Please check this out https://register.clinicaltrials.gov/prs/html/about-ctrp.html

Disease Coding in CTRP for Accrual

• If you are currently using ICD-09 and CTEP SDC please continue to use these codes

• With the upcoming release of CTRP version 3.9.1 due to be released soon, centers will have the ability to submit their disease codes in ICD-0-3 format as well as ICD-09 and CTEP SDC

• It is the responsibility of the center to review their trials and assign disease codes that they feel accurately reflect the subjects in their study

Accrual Reporting to CTRP

• As of Q4 2012 Centers were to begin submitting Accrual data for all trials in CTRP- Institutional trials should have Complete Accrual data- Industrial trials should have Summary Accrual data- CTEP and DCP managed trials will have accrual data pulled

from these systems into CTRP• The requirements for Accrual submissions were

documented in the previous round of CTRP Administrative Supplemental Funding and can be found at: https://wiki.nci.nih.gov/display/CTRP/NCI+Clinical+Trials+Reporting+Program+Subject+Accrual+User%27s+Guide

• CTRP is currently reviewing Centers accrual data reported in the system and reaching out to those Centers needing assistance.

Submitting Amendments

• Currently, Amendments can be submitted any time after a trial is abstracted and verified

• This presents a problem when Centers try to submit an amendment shortly after their previous submission

• Future system enhancements will allow centers to submit an amendment when the trial recruitment status is “in review”

Site Administration Authority

• Site Administrators manage:- Rights for other owners at your organization- Trial ownership

• If a Center has only 1 Site Administrator and that person should leave without first creating a new Site Admin, it can create problems for the center and for CTRO

• Future system enhancements will allow CTRO to act as a site admin for all trials to assign trial ownership.

• If your center has only 1 site administrator assigned please make sure to assign a new administrator before that person leaves

Primary Completion Dates

• There are some CTEP and DCP PIO managed trials that do not have an accurate Primary Completion Date (PCD) associated with the trial.

• As part of our joint effort with CTEP and DCP to correct these dates, both the CTRO and the CTEP/DCP PIO have been reaching out to Cancer Centers and Cooperative Groups to get valid PCD’s

• The PCD has a serious impact on the FDAAA reporting requirements and the results reporting timeframes.

• Please, if CTRO or the CTEP/DCP PIO reach out to you requesting a valid PCD, try and respond to them as soon as you can.

CTRP 2013 Administrative Supplement

New 2013 CTRP Supplement Funding

• CTRP has released the latest Administrative Supplement announcement on April 15, 2013 to the Cancer Center Directors

• Supplement applications (signed PDF) are due at the NCI (NCICTRO@mail.nih.gov) by COB Friday, May 31, 2013

• The Latest Supplement Announcement can be found at: http://cancercenters.cancer.gov/documents/2013%20CTRPSupplementAwardAnnouncement508.pdf

(and also on the CTRP Webpage)

Supplemental Funding - Major Changes to the New Supplement

• This award will be a 2-year award at $75,000/yr• Funding for this years supplement as well as year 2 will be

contingent on satisfactory progress towards fulfillment of the 5 tasks outlined in the Requirements Section (as well as availability of funds)

• Funding will coincide with the budget period of each centers P30 Cancer Center Award.

• Center should be working towards sustainable data submissions to CTRP

• It is anticipated that this will be the last round of supplemental funding of CTRP

• If you have specific Supplement questions you would like to have addressed, please send them to me at NCICTRO@mail.nih.gov

Thank You