Clinical Trial Registration, Amendments, and Updates
When to Register Trials
Interventional 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. Observational studies should be registered sufficiently in advance, so that they can appear on the CTRP-generated Data Table 4 for observational studies in support of the Cancer Center Support Grant application.
Which Trials Need to be Registered
All Interventional trials directly and indirectly funded by NCI which open to accrual as of or after 1/1/2009 and observational studies open to accrual as of or after 1/1/2020, including all taking place in NCI-Designated Cancer Centers, need to be registered in CTRP. This also includes both industrial trials and non-cancer trials.
CTRP supports, but does not currently require, reporting of Expanded Access/Compassionate Use studies. Ancillary-Correlative and single patient studies are not in scope for CTRP registration and reporting.
- All interventional trials and observational studies must be registered in CTRP to appear on a CTRP-generated Data Table 4.
- NCI-Designated Cancer Centers can request exclusion of expanded access/compassionate use trials and 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 funded by NCI. Exception: The following trials do not need to be registered in CTRP, as this information will be transferred to CTRP within NCI:
- Trials that are reviewed and monitored by NCI CTEP PIO and NCI DCP PIO. This applies to all NCTN, NCORP, and ETCTN trials.
- Trials that take place in NCI Center for Cancer Research (CCR).
How to Register Trials
There are 3 ways to register trials with CTRP:
Trial owners enter a limited number of data elements into the CTRP website and upload documents required for registration, in a machine-readable for only, e.g., Microsoft Word, Adobe PDF, including:
- Clinical trial protocol
- IRB approval form
- Informed consent form (if not part of the protocol document) – optional for observational studies
- A list of participating sites (if not part of the protocol document)
Submit a full protocol document and consent form.
- Incomplete documents, e.g., protocol summaries will not be accepted.
- Documents required for registration that are not machine readable will not be accepted.
Following submission, the NCI Clinical Trials Reporting Office (CTRO) abstracts the protocol, capturing key data elements (e.g., eligibility criteria, trial design, outcome measures).
- Importing the registration record into CTRP from ClincalTrials.gov
Participating sites use the NCT ID to retrieve the ClinicalTrials.gov record and import this record into CTRP for registration. This can be used only for the following trials:
- Industrial Trials and Trials Whose Lead Organization is not an NCI-awardee
- Expanded Access Trials
- 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:
- Treatment administration
- Study design including target enrollment
- Principal Investigator
Amendments are to include all changes and updates since the most recent protocol submission.
Overall trial and participating site status changes (e.g., a change from "Active" to "Temporarily Closed to Accrual") should be submitted no later than 30 days after the status change took place.
Updates to basic trial data should be reported to CTRP at least 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. Note: If the Interventional trial or Observational study is multi-institutional, then the lead organization should submit amendments, updates and changes in participating sites as frequently as needed to assure the accuracy of the use of the record by participating sites.
Bi-annual Record Verification – Required for All Trials/Studies Registered in CTRP
Trials must be reviewed for accuracy at least twice each year. Automated email reminders will be sent to trial owners, trial submitters, and site administrators one month prior to the Trial Record Verification due date and monthly thereafter until the trial(s) have been verified.
NCI CTRP and ClinicalTrials.gov
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. NCI cannot submit data to ClinicalTrials.gov on behalf of NCI awardees for non-NCI sponsored trials.
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, NCI CTRP UPLOAD). This feature 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. Advantages of using “Upload from NCI CTRP” feature include reuse of the information abstracted in CTRP as well as consistent formatting of persons and organizations.