Page History

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.

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.

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 any Closed to Accrual status or the Complete status, 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

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.
   

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

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

   

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.
  
• 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.

Trial Status Transitions