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titleGather all the protocol data you need before you begin

The system logs you off if it detects that you have not used the application for 90 minutes.

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The system locks you out after three unsuccessful attempts to log in within 24 hours. In the event that you have been locked out of your account, contact CBIIT Application Support at  ncicbiit@mail.nih.gov , or phone: 240-276-5541 or toll free: 888-478-4423. If you have forgotten your password, see Resetting Your NCI Password .

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Trial status refers to the current stage or state of a clinical trial or study relative to other stages and its ability to enroll participants/patients.

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Valid trial statuses used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values. ClinicalTrials.gov status definitions are provided in Trial Status Values in the CTRP and ClinicalTrials.gov.

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titleErrors and Warnings

The system validates each new status as you add it, as well as when you review the trial information before submitting the trial for registration.

If you add a status that does not conform to the rules provided in Trial Status Transitions , the system displays errors and/or warnings. Warnings indicate that fixing the record is optional. However, Errors indicate that you must correct an invalid transition in order to submit the trial for registration.


If you register a trial after it has reached the status Active or Closed to Accrual, you must create a complete Trial Status History by adding all previous statuses in order, as per the rules provided in Trial Status Transitions.

How to Complete the Trial Status Section

Trial Status section of the Register Trial page

  1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. All fields in this section are required.

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    Trial Status Fields - Include v4.4
    Trial Status Fields - Include v4.4

  2. Click Add Status.
    The new status record is displayed.

    Trial Status section with status entry and warnings

  3. If the system indicates that the status you added is invalid, do one of the following.  
  •  To edit the status, in the Actions column, click the Edit icon and make changes as indicated in the Error and/or Warning message.
    Edit Trial Status dialog box
  • To delete the status, in the Actions column, click the Delete icon. Enter a comment indicating the reason why you deleted the record, and then add the correct status information.
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Closure of Participating Sites When Trial Closes - Include v4.4
Closure of Participating Sites When Trial Closes - Include v4.4

The system displays the following warning if you enter any of the statuses above:

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Trial Status Transitions

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Trial Status Flow Table and Diagram - Include v4.4
Trial Status Flow Table and Diagram - Include v4.4

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