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Clinical Trials Reporting Program

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How to Register Trials

The following steps are designed to guide you through the registration of trials with NCI's Clinical Trials Reporting Program.

Registration Steps - 6 steps to register trials
Decide whether your organization's interventional trials need to be reported



o  Is the trial managed by the Cancer Therapy Evaluation Program (CTEP) or the Division of Cancer Prevention (DCP) Protocol and Information Offices (PIOs) or NCI’s Center for Cancer Research (CCR)?

If yes, you do not have to register the trial with CTRP. NCI will transfer data for this trial to CTRP.
Gather Required Information


Before you begin to register your trials with CTRP, it will be helpful to gather the following information for each trial, as applicable:

o  Lead Organization Trial Identifier
o  Trial Title, Type, Phase, Purpose (prevention, treatment, diagnostic)
o  Lead Organization and Principal Investigator
o  Sponsor / Responsible Party
o  Summary 4 Information (Funding Category and Funding Sponsor)
o  Status and Status Date (Study Start and Completion Date)
o  NIH Grant Information (Funding Mechanism, Institute Code, Serial Number, NCI Division or Program Code)
o  IND/IDE Information (Number, Grantor, Holder Type)

You will also need to upload the following trial-related documents in support of each trial's registration:

o  Protocol Document (or in the case of Industrial protocols, submit the CTRP Registry Abbreviated Trial Template in place of the protocol document)
o  IRB Approval
o  Informed Consent (if not embedded within the protocol document)
o  List of participating Sites for Multi-Center Studies (use the CTRP Registry Complete Trial Participating Sites Template if not already described within the protocol document)
Create User Account



o  Create An Account. Enter an email account and create a password. You will receive a confirmation email.
o  Account Profile. Click on the link listed in your confirmation email to activate your account and to enter your Account Profile information.
o  Log In. After entering the Account Profile info you will be asked to log in again. If you forgot your password, then reset it.
Search Trials


After you are logged into the CTRP Registration Site, you may want to check if the trial(s) you are registering have already been submitted.

Search My Trials. Use this feature to find trials that have been submitted through your account

Search All Trials. Use this feature to view select data on all registered trials within CTRP from all submitting organizations

Submit Trials


o  Enter Trial Information. Complete the data fields for each trial. "Drop down" menus can help you make a selection. Fields marked with an asterisk are required. You will not be able to register the trial without completing these fields.
o  Upload Trial Documents. The following trial-related documents are required as part of your trial's registration to CTRP:
  o  Protocol Document (or in the case of Industrial protocols, submit the CTRP Registry Abbreviated Trial Template in place of the protocol document)
  o  IRB approval
  o  Informed consent (if not embedded within the protocol document)
  o  List of participating sites for multi-center studies (use the CTRP Registry Complete Trial Participating Sites Template if not already described within the protocol document)

You can attach these files to your registration. You can "browse" the files on your computer and select a file.

o  Submit. Review the trial information that you have entered and click "Submit." You may print the information for your trial prior to submitting it.

If you need to make any changes after you have submitted the trial, please contact the CTRO staff by email.



Verify Trial Information


o  Review. You will receive an email within 48 hours letting you know whether the trial has been accepted or rejected by the Clinical Trials Reporting Office (CTRO).

The CTRO will include reason(s) if the trial is rejected in the email (e.g., a duplicate submission, missing documents). The email will also provide you with a unique identifier assigned by NCI for your trial.

o  Abstraction. 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.
o  Confirmation. Following abstraction, the CTRO will send you an email with a Trial Summary Report (TSR) for your review as an attachment in a Word format that you can edit. You can email us with corrections or questions about the TSR.

Within 5 business days, send an email to the CTRO verifying that the trial has been abstracted correctly. If we have not heard from you within 5 business days, the CTRO will assume the TSR is acceptable.

Step 1: Decide whether your organization's interventional trials need to be reported

o  Has the trial already been reported to NCI through its Cancer Therapy Evaluation Program (CTEP) or the Division of Cancer Prevention (DCP)?

If yes, you do not have to register the trial with CTRP. NCI will transfer data for this trial to CTRP.

Step 2:Gather Required Information

Before you begin to register your trials with CTRP, it will be helpful to gather the following information for each trial, as applicable:

o  Lead Organization Trial Identifier
o  Trial Title, Type, Phase, Purpose (prevention, treatment, diagnostic)
o  Lead Organization and Principal Investigator
o  Sponsor / Responsible Party
o  Summary 4 Information (Funding Category and Funding Sponsor)
o  Status and Status Date (Study Start and Completion Date)
o  NIH Grant Information (Funding Mechanism, Institute Code, Serial Number, NCI Division or Program Code)
o  IND/IDE Information (Number, Grantor, Holder Type)
You will also need to upload the following trial-related documents in support of each trial's registration:
o  Protocol Document (or in the case of proprietary protocols, submit the CTRP Registry Abbreviated Trial Template in place of the protocol document)
o  IRB Approval
o  Informed Consent (if not embedded within the protocol document)
o  List of participating sites for multi-center studies (use the CTRP Registry Complete Trial Participating Sites Template if not already described within the protocol document)
Step 3: Create User Account
o  Create An Account. Enter an email account and create a password. You will receive a confirmation email.
o  Account Profile. Click on the link listed in your confirmation email to activate your account and to enter your Account Profile information.
o  Log In. After entering the Account Profile info you will be asked to log in again. If you forgot your password, then reset it.
o  Search Screen. You will be routed to a Search Screen after log-in.

Step 4: Search Trials

After you are logged into the CTRP Registration Site, you may want to check if you or someone at your organization has already submitted the trial(s) that you are registering. Also, for multi-center trials you can check if other centers have already registered the trial.

Search My Trials. Use this feature to find trials that have been submitted through your account.

Search All Trials. Use this feature to view select data on all registered trials within CTRP from all submitting organizations.

 

o  Confirmation. In the case of a protocol abstraction, the CTRO will send you an email with a Trial Summary Report for your review. You can email us with corrections or questions about the Trial Summary Report.
 Verify that the trial has been abstracted correctly and respond within 5 business days to let the CRPO know if the abstraction is correct.
 If we have not heard from you within 5 business days, the CTRO will assume the Trial Summary Report is acceptable.

 

Step 5: Submit Trials

o  Enter Trial Information. Complete the data fields for each trial. "Drop down" menus can help you make a selection. Fields marked with an asterisk are required. You will not be able to register the trial without completing these fields.
o  Upload Trial Documents. The following trial-related documents are required as part of your trial's registration to CTRP:
  o  Protocol Document (or in the case of Industrial protocols, submit the CTRP Registry Abbreviated Trial Template in place of the protocol document)
  o  IRB approval
  o  Informed consent (if not embedded within the protocol document)
  o  

List of participating sites for multi-center studies (use the CTRP Registry Complete Trial Participating Sites Template if not already described within the protocol document)

You can attach these files to your registration. You can "browse" the files on your computer and select a file.

o  

Submit. Review the trial information that you have entered and click "Submit." You may print the information for your trial prior to submitting it.

If you need to make any changes after you have submitted the trial, please contact the CTRO staff by email.

Step 6: Verify Trial Information
o  

Review. You will receive an email within 48 hours letting you know whether the trial has been accepted or rejected by the Clinical Trials Reporting Office (CTRO).

The CTRO will include reason(s) if the trial is rejected in the email (e.g., a duplicate submission, missing documents). The email will also provide you with a unique identifier assigned by NCI for your trial.

o  Abstraction. When a protocol document has been submitted during registration, the CTRO will abstract information from the protocol and the other supporting documents. The CTRO will contact you via email if there are any questions or need for clarification.
o  Confirmation. In the case of a protocol abstraction, the CTRO will send you an email with a Trial Summary Report  (TSR) as an editable Word format attachment for your review. You can email us with corrections or questions about the Trial Summary Report.

Verify that the trial has been abstracted correctly and respond within 5 business days to let the CTRO know if the abstraction is correct.

If we have not heard from you within 5 business days, the CTRO will assume the Trial Summary Report is acceptable.

If you have questions or comments regarding this document, or other CTRP topics, please contact us at NCICTRO@mail.nih.gov

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