CTRP Program - FAQs
- What is the purpose of the Clinical Trials Reporting Program (CTRP)?
- How will CTRP be connected to other databases within NCI and NIH?
- Will CTRP support the Cancer Centers Summary 4/ Data Table Report?
- What trials does NCI expect to be registered in CTRP?
- Will CTRP register my trials with Clinical Trials.gov for me?
- If I register a trial with CTRP, will CTRP send the trial to PDQ?
- Where do I go to submit the accrual reporting data?
- How do I report accrual on an open trial if no subjects have yet accrued?
- How long do I continue accrual reporting following accrual of the last patient to the study?
- How do I obtain access to my site’s registered trials for accrual reporting purposes?
- My trial is still in review with the Institutional Review Board (IRB). Can I still submit to CTRP?
- If my center received a CTRP Administrative Supplement, do I need to submit specific CTRP progress reports?
What is the purpose of the Clinical Trials Reporting Program (CTRP)?The CTRP fulfills a major initiative of the Clinical Trials Working Group (CTWG) Report (PDF) : to provide a shared foundation of information by establishing a comprehensive database containing regularly updated information on all NCI-supported clinical trials. The April 2010 Institute of Medicine report, National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program reiterated the need for a comprehensive database of cancer clinical trials. A comprehensive database of the entire NCI portfolio will help to identify gaps in clinical research and duplicative studies, as well as facilitate effective clinical trial prioritization.
How will CTRP be connected to other databases within NCI and NIH?The CTRP informatics system is based on NCI Enterprise Services, a set of common, shared information services. CTRP will receive data from databases maintained within the Cancer Therapy Evaluation Program (CTEP), the Division of Cancer Prevention (DCP) and the Center for Cancer Research (CCR), using NCI Enterprise Services where possible and file transfer where not. It is expected that over time synchronization between all systems will be seamlessly migrated to NCI Enterprise Services.
Will CTRP support the Cancer Centers Summary 4/Data Table 4 Report?CTRP is working with the NCI Cancer Centers Program to address the reporting requirements for Summary 4 / Data Table 4. The capability for CTRP to generate information in support of a Summary/Data Table 4 report for interventional trials is in development.
What trials does NCI expect to be registered in CTRP?NCI expects CTRP registration for all NCI-supported interventional trials that were opened to accrual as of or after January 1, 2009.
"NCI-supported" means "all trials sponsored or otherwise financially supported by NCI." For instance, NCI expects all interventional clinical trials, however sponsored, that are conducted in NCI-designated Cancer Centers to be registered (with the exception below). Thus, trials that NCI-designated Cancer Centers report as interventional trials in the Cancer Center Summary 4 Report to NCI are expected to be reported through CTRP. Both industry-sponsored and investigator-initiated trials conducted at NCI-designated Cancer Centers should be registered.
Exception: Trials that are reviewed and monitored by NCI CTEP and DCP PIOs need not be registered through the CTRP website, as this information will be transferred to CTRP within NCI. This exception applies to all CTEP trials submitted via the Clinical Data Update System (CDUS), including all Cooperative Group trials, and all early phase trials submitted to the Clinical Trials Monitoring Service (CTMS) operated by Theradex.
Will CTRP register my trials with ClinicalTrials.gov for me?No. The NIH has advised NCI that it can no longer submit data to ClinicalTrials.gov on behalf of NCI awardees either through CTRP, PDQ or any other system. NCI awardees that are sponsors as defined by the Food and Drug Administration Amendments Act of 2007, P.L. 110-85 (FDAAA) are responsible for submitting data to ClinicalTrials.gov in compliance with FDAAA. The NCI is not in control of these requirements. As a result, CTRP was enhanced in 2009 to provide a clinical trial abstract in an electronic format that after review by the awardee, is suitable for registration in ClinicalTrials.gov. When you register your trial with CTRP, you can request an XML file be sent to your institution for independent validation. You may then submit that XML file to ClinicalTrials.gov, preventing the need for duplicate registrations.
If I register a trial with CTRP, will CTRP send the trial to PDQ?Yes. CTRP is intended to act as a "one stop shop" for reporting. Data entered into CTRP will be received by PDQ.
How do I report accrual on an open trial if no subjects have yet accrued?
If a trial is active, but there is no accrual to date on the trial, a collections record only, such as the sample below, should be submittedEXAMPLE: COLLECTIONS, NCI-2012-01234
Where do I go to submit the accrual reporting data?
How long do I continue accrual reporting following accrual of the last patient to the study?
Once your trial has closed to Accrual and all participants have been registered with CTRP, you may, but are not required to continue to report accruals for that trial.
How do I obtain access to my site’s registered trials for accrual reporting purposes?
If you do not already have access to your sites registered trials, please contact the CTRO (NCICTRO@mail.nih.gov ) and request access.
Note: do not request access for reporting accrual for your site for CTEP/DCP PIO managed trials. Accrual data for these trials will be transferred directly to CTRP from CTEP/DCP PIO.
My trial is still in review with the Institutional Review Board (IRB). Can I still submit to CTRP?
Yes, you can still submit your trial for processing to CTRP. In the absence of the IRB approval form, please attach a Word document that states your trial is still under IRB review and state the name of your IRB. Please be sure to update your record via Update in the CTRP Registration Site when your trial has been approved by the IRB.
If my center received a CTRP Administrative Supplement, do I need to submit specific CTRP progress reports?
Yes. As part of your CTRP Supplement agreement, the center is to submit a brief, 6 month and 1 year progress report to the CTRP Program Director addressing each of the stated tasks in the supplement agreement.