In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials Reporting Program

Page Options

  • Print This Page
  • Email This Document

How to Register Trials

The following steps are designed to guide you through the process of registering trials with NCI's Clinical Trials Reporting Program (CTRP). For detailed instructions, see the NCI Clinical Trials Reporting Program Registration Site User's Guide.

Before You Begin

Before you begin to register your trial(s) with the CTRP, do the following:

  1. Determine whether your organization's interventional trials need to be reported.

    Do not register your trial if it is managed by any of the following organizations:

    Note: NCI will transfer data from these types of trials to CTRP.

  2. Gather required information.

    Gather the following information for each trial, as applicable:

    • Lead Organization Trial Identifier
    • Trial Title, Type, Phase, Purpose (Prevention, Treatment, Diagnostic, etc.)
    • Lead Organization and Principal Investigator
    • Sponsor/Responsible Party
    • Summary 4 Information (Funding Category and all Funding Sponsors)
    • Status and Status Dates
    • NIH Grant Information (Funding Mechanism, Institute Code, Serial Number, NCI Division or Program Code)
    • IND/IDE Information (Number, Grantor, Holder Type)
    • Trial-related documents in support of each trial's registration:
      • For complete trials (i.e., all National, Externally-Peer-Reviewed and Institutional trials):
        • Complete protocol document
        • Participating sites (if not included in the protocol document). Multi-site trials require a list of participating sites and contact information. Use the CTRP Registration Complete Trial Participating Sites Template.
        • Informed Consent (if not included in the protocol document)
        • IRB Approval

     3.  Create a user account in the NCI CTRP Registration application.

Main Steps for Registering Your Trial

Once you have gathered all the trial information, log in to the CTRP Registration site, and then continue with the steps below.

  1. Search for Duplicate Trials.

Determine if the trial(s) you are registering have already been submitted by doing the following.

  • Use the Search My Trials feature to determine whether the trial that you are preparing to register has already been submitted through your account.
  • Use the Search All Trials feature to determine whether the trial has already been submitted to CTRP by another organization.

2.  Enter Trial Information.

Complete the data fields for each trial. Fields marked with an asterisk (*) are required. You will not be able to register the trial without completing these fields.

Note: Industrial trials can now be registered in CTRP by specifying the ClinicalTrials.gov NCT identifiers associated with the trials and importing them from ClinicalTrials.gov directly. This avoids the need to manually enter industrial trial information.

3.  Upload Trial Documents.

Refer to the list of required documents above. You can attach these files to your registration by browsing for, and selecting, the files on your computer. For further information about trial-related documents, see Recording Trial-Related Documents.

Note: You can send your Abbreviated Trial Participating Site document to the NCI's Clinical Trials Reporting Office (CTRO), either as an attachment to your registration or by an email to the CTRO at NCICTRO@mail.nih.gov

4.  Submit Your Trial.

Review the trial information that you have entered and then click "Submit." You can print the trial information prior to submitting it.

Note: If you need to make any changes after you have submitted the trial, contact NCI's Clinical Trials Reporting Office (CTRO) by email at NCICTRO@mail.nih.gov.

Main Steps for Verifying Trial Information

NCI's Clinical Trials Reporting Office (CTRO) will send you an email confirming receipt of your trial. You will receive another email (within 10 days) indicating if the trial has been accepted, rejected or put on hold. If the trial has been accepted, the email will include a Trial Summary Report (TSR), a unique identifier assigned by NCI for your trial, and, if requested, an XML file of your trial for you to review and submit to ClinicalTrials.gov. If a CTRO trial abstractor has rejected the trial, the email will include the reason(s) for rejection (e.g., a duplicate submission, missing documents).

  1. Review the information you submitted.

Following submission of a national, externally peer-reviewed, or institutional trial, NCI's Clinical Trials Reporting Office (CTRO) will abstract information from the protocol and other supporting documents. The CTRO will contact you via email if there are questions or if additional clarification is needed.

2.  Confirm the abstraction.

Following abstraction, the CTRO will send you an email with a TSR for your review as an attachment in a Word format that you can edit. Please review the TSR. You can email the CTRO with corrections or questions about the TSR.

Important: Within 5 business days of receipt of the TSR, you should send an email to the CTRO verifying that the trial has been abstracted correctly. If the CTRO has not heard from you within 5 business days, the CTRO will assume that the TSR is accurate.

     3.  Review and verify trial data semi-annually.

We ask that trial submitters review their trial data semi-annually. Email reminders will be sent to open trial record owners, submitters, and site administrators to verify their trial data in CTRP on a semi-annual basis.