Clinical Trial Registration, Amendments, and Updates
When to Register Trials
Trials should be registered in CTRP prior to enrollment of the first patient. Trials can be registered prior to activation so that the registration record can be made available for ClinicalTrials.gov registration.
Which Trials Need to be Registered
All NCI-supported interventional trials, including all taking place in NCI-Designated Cancer Centers, need to be registered. This also includes industrial trials and trials that are not cancer-focused.
CTRP supports, but does not currently require, submission of non-interventional studies:
- All interventional trials and non-interventional studies must be registered in CTRP in order to appear on a CTRP-generated Data Table 4.
- NCI-Designated Cancer Centers can request exclusion of trials that are not cancer-focused from their CTRP-generated Data Table 4.
Who Needs to Register Trials
All NCI-Designated Cancer Centers and other NCI awardees are expected to register any trial that is either directly or indirectly supported by NCI. The following exceptions do not need to be registered through the CTRP website, as this information will be transferred within NCI:
- Trials that are reviewed and monitored by NCI CTEP PIO and NCI DCP PIO. This 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.
- Trials that take place in NCI's Center for Cancer Research.
|NCI-Supported||Not NCI-Supported (e.g., Industry -Sponsored, Investigator-Initiated||Trials Reviewed and Monitored by NCI CTEP and DCP PIOs and CCR|
|NCI-Designated Cancer Center||Register in CTRP||Register in CTRP||Not Required|
|Other Awardees||Register in CTRP||Not Required||Not Required|
How to Register Trials
There are 3 ways to register trials with CTRP:
- Online via the CTRP Registration Site
Trial owners manually enter a limited number of data elements via the CTRP system and upload related documents (Microsoft Word and Adobe PDF are acceptable formats):
- Trial protocol
- IRB approval form
- Informed consent forms
- A list of participating sites
- 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 firstname.lastname@example.org.
Trial Policies: Amendments, Updates and Verification
Amendments to a clinical trial protocol must be submitted to CTRP within 20 days of the approval by the Institutional Review Board (IRB). Amendments include changes that substantively alter one or more of the following:
- the treatment administered
- the study design
- the sites where patients are being enrolled on the trial
Amendments are to include all changes and updates since the most recent protocol submission.
Status changes in the overall trial (e.g., a change from "Active" to "Temporarily Closed to Accrual") should be submitted no later than 30 days after the change took place.
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 both 30 and 15 days prior to the trial review due date.
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.
NCI worked with National Library of Medicine (NLM) ClinicalTrials.gov to implement the “Upload from NCI CTRP” function in ClinicalTrials.gov. (PRS User's Guide, Section 9.1). 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.