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?
How do I register trials with CTRP?
Trials may be submitted online via the NCI CTRP Registration Site.
Registration may occur through the manual entry of approximately 15-20 data elements and upload of related documents, which may include the trial protocol, IRB approval, informed consent forms, and a list of participating sites. Trials may also be submitted electronically by batch file loading.
Another approach is for system developers and vendors to configure their applications to allow utilization of NCI Enterprise Services. The NCI will work with individual centers to assist them should they wish 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 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 can submit trials using the NCI CTRP Registration Site. Registration requires the entry of a limited number of data elements and the 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).
Study amendments and updates should be reported starting in the 2nd quarter of 2012.
Quarterly patient accrual data should be reported starting in the 3rd quarter of 2012.
