Clinical Trial Registration, Amendments, and Updates
Which Trials Need to be Registered
NCI expects CTRP registration for all 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 Data Table 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 following exception:
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 NCTN trials, and all early phase trials submitted to the Clinical Trials Monitoring Service (CTMS) operated by Theradex.
Trial Registration and Amendment Policies
NCI-supported trials should be registered in CTRP prior to the enrollment of the first patient.
Amendments to a clinical trial protocol should be submitted to CTRP within 20 days of the approval by the Institutional Review Board (IRB). Amendments include changes that substantively alter:
- the treatment administered; and/or
- the study design; and/or
- the sites in which patients are being enrolled on the trial.
Amendments are to include all changes (including updates) since the last change to the protocol was submitted.
Status changes should be submitted no later than 30 days after the change took place. Status changes include changes in the overall status of the trials (e.g., a change from Active to Temporarily Closed to Accrual, a change from Temporarily Closed to Accrual to Complete, etc)
Trial Update and Verification Policies
Updates to basic trial data should be reported to CTRP annually. Updates are defined as other changes to the protocol that do not substantively affect the scientific conduct of the study, the study design, and/or the sites in which patients are being enrolled on the trial.
Trials must be reviewed for accuracy twice each year. The trial review date is calculated using the last verification date. Automated email reminders will be sent to trial owners, submitters and site administrators 30 days prior and 15 days prior to the trial review due date.
How to Register Trials
There are 3 ways to register trials with CTRP:
- Online via the CTRP Registration Site
With this method, a limited number of data elements are manually entered via the CTRP system (see data entry responsibilities, below). Trial owners also must upload related documents, including the trial protocol, IRB approval form, informed consent forms, and a list of participating sites. CTRP accepts Microsoft Word, Adobe PDF, and WordPerfect formats.
- Imported from ClincalTrials.gov (Industrial Trials Only)
Industrial trials can be registered in CTRP using ClinicalTrials.gov identifiers, allowing data to be imported directly from ClinicalTrials.gov.
- Using Web Services
NCI will work with individual cancer centers wishing to adapt their CDMS to use the CTRP registration service. If you are interested in using this approach, please contact us at email@example.com.
Data Entry Responsibilities
Following trial registration, the NCI’s Clinical Trials Reporting Office complete the abstraction of the protocol, capturing data including eligibility criteria, trial design, outcome measures, etc.
NCI CTRP and ClinicalTrials.gov
NCI cannot submit data to ClinicalTrials.gov on behalf of NCI awardees. 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.
NCI has worked with the National Library of Medicine (NLM) ClinicalTrials.gov team to implement the “Upload from NCI CTRP” function in ClinicalTrials.gov. This enables clinical trial sponsors, as defined by 21 CFR 50.3, to use CTRP data to register and update their clinical trial records in their organization’s ClinicalTrials.gov account.