Data Use, Access, and Sharing
Will I have access to data from my submissions?
Yes. In response to requests from users, NCI has developed a basic reporting system to allow submitting organizations to use CTRP for their own clinical research portfolio management. Centers can login to CTRP and perform searches on all trials they have submitted or are listed as a participating site on. If a center should require a more detailed report of information on their trials, they may submit a request via the CTRO (firstname.lastname@example.org) and a CTRP analyst will work with them to generate a custom report.
Will my data be shared with awardees or others outside of NCI?
NCI does not intend that protocol documents, IRB approval, Informed Consent forms, and Trial Summary Reports be shared with anyone other than the submitter. However, all records in the possession or control of the NIH are subject to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, and must be released in response to a FOIA request unless NIH determines that the record is exempt from release under one of the FOIA's exemptions. Since FOIA affords requesters an opportunity to contest an agency's determination, NCI awardees subject to this policy are advised that records that are determined by NIH to be exempt could subsequently be required to be released in response to FOIA requests.
Will I be able to access my accrual information in CTRP?
Yes. Submitters will have access within CTRP to view any accrual information they have submitted for trials on which they are the Lead Organization.
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 4 /Data Table 4 report for interventional trials is in development.
If I register a trial with CTRP, will CTRP send the trial to Cancer.gov?
Yes. CTRP is intended to act as a "one stop shop" for reporting. Data entered into CTRP will be received by Cancer.gov.
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. Where NCI is the sponsor of a trial, NCI is responsible for registration and maintenance of the ClinicalTrials.gov record.
Can verified CTRP registration records be used to update ClinicalTrials.gov records?
Yes. After CTRP registration verification, you have the option to use the "Upload from NCI CTRP" feature in ClinicalTrials.gov's Protocol Registration System (PRS) to register and update the protocol record.