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. 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:

   • Cancer Therapy Evaluation Program (CTEP)
   • Division of Cancer Prevention (DCP)
   • DCP Protocol and Information Offices (PIOs)
   • NCI's Center for Cancer Research (CCR)

   Note: NCI will transfer data from these types of trials to the 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)
   • Lead Organization and Principal Investigator
   • Sponsor/Responsible Party
   • Summary 4 Information (Funding Category and Funding Sponsor)
   • Status and Status Date (Study Start and Completion Date)
   • 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
       • 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 Registry Complete Trial Participating Sites Template.
       • Informed Consent (if not included in the protocol document)
       • IRB Approval
     • For abbreviated trials
       • CTRP Abbreviated Trial Template (for registering trials that do not have an NCT number)
       • CTRP Registry Abbreviated Participating Sites Template
3. Create a user account in the NCI CTRP Registration application.
   • If you are a new user AND you do not have an NIH account, request one via the CTRP Registration Site. Follow the instructions in Creating New CTRP Registration Site Accounts.
   • If you are a new user AND you have an NIH account, use your current credentials to register for a CTRP account via the CTRP Registration Site. Follow the instructions in Creating New CTRP Registration Site Accounts Using NIH or NCI Credentials.

Main Steps for Registering Your Trial

Once you have gathered all the trial information, log in to the CTRP Registration site at https://trials.nci.nih.gov/registry/protected/disClaimerAction.action?actionName=searchTrial.action, 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 find trials that have been submitted through your account.
   • Use the Search All Trials feature to view select data on all registered trials within CTRP from all submitting organizations.
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.

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 CTRO as an attachment.

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 the Clinical Trials Reporting Office  (CTRO) by email at NCICTRO@mail.nih.gov.

Main Steps for Verifying Trial Information

The Clinical Trials Reporting Office (CTRO) will send you an email within 48 hours of your trial submission to let you know whether they have accepted or rejected your trial. The email will also provide you with a Trial Summary Report (TSR) and a unique identifier assigned by NCI for your trial.
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, the 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. You can email the CTRO with corrections or questions about the TSR.
   Important: Within 5 business days, 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.