Expectations for Awardees - FAQs
- How do I register trials with CTRP?
- What trials does NCI expect to be registered in CTRP?
- What data do I need to report and when?
- What progress reports are expected from Cancer Centers that have received CTRP Administrative Supplements?
How do I register trials with CTRP?
Trials may be submitted online via the NCI CTRP Registration Site.
Trials may be registered manually through the web interface on the NCI CTRP Registration Site. Manual entry requires entering a limited number of data elements and requires upload of related documents, which may include the trial protocol, IRB approval, informed consent forms, and a list of participating sites. Multiple trials may also be submitted all at one time electronically by batch file loading. Please read the instructions for Batch File uploading.
Additionally, industrial trials can now be registered in CTRP by specifying the ClinicalTrials.gov identifiers associated with the trials and importing them from ClinicalTrials.gov directly. This avoids the need to manually enter industrial trial information.
Another approach is to register trials utilizing the NCI Enterprise Services. NCI has worked with system developers and vendors to configure their applications to allow utilization of NCI Enterprise Services by the Clinical Data Management Systems (CDMS). The NCI will continue to work with individual centers to assist them should they wish to adapt their CDMS to use the registration service. If you have questions or comments regarding this approach, please contact us at NCICTRO@mail.nih.gov.
What trials does NCI expect to be registered in CTRP?
NCI expects CTRP registration for all new NCI-supported interventional clinical trials and existing 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.
NCI also expects awardees outside NCI-designated Cancer Centers to register NCI-supported trials through CTRP, subject to the exception below.
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 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.
NCI is reviewing requirements for the registration of observational, ancillary and correlative studies.
What data do I need to report and when?
You need to submit all NCI-supported interventional trials that were opened to accrual as of or after January 1, 2009 using the NCI CTRP Registration Site. Registration requires the entry of a limited number of data elements and the required upload of related documents, which may include the trial protocol, IRB approval, informed consent forms, and a list of participating sites (for multi-site trials).
All study amendments should be reported to CTRP within 20 days of IRB approval and updates should be reported annually.
As of October 1, 2012, quarterly patient accrual data should be reported to CTRP. The Lead Organization is required to report all accrual information for their site as well as any participating sites on their trial. Centers should report basic summary accrual data for industrial trials in which they are participating. More detailed information is available in the Accrual User's Guide.
We ask that trial submitters review their trial data semi-annually. Email reminders will be sent to open trial record owners, submitters, and site administrators to verify their trial data in CTRP on a semi-annual basis.