Page History

Trial status refers to the current stage or state of participant/patient enrollment at the participating site level. Trial Start Dates and Primary Completion Dates are related to the current trial status. See Trial Status Rules and Trial Status Transitions.

Status information is optional for Abbreviated trials.

The Trial Status abstraction workflow is slightly different for Super, Administrative, and Scientific Abstractors. Although each of the abstractor roles can change the status transitions, the trial check in/check out behavior varies. See the table in Checking In and Checking Out Trials for details.

Trial Status Abstraction

How to Abstract Trial Status Information

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Administrative Data menu, click Trial Status.
   The Trial Status page appears.
   

3. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

   Field Label	Description/Instructions
   Current Trial Status*	Select the trial’s accrual status from the drop-down list. Valid values are as follows: Include Page Trial Status Definitions - Include v4.4 Trial Status Definitions - Include v4.4
   Current Trial Status Date*	Enter the date on which the current trial status became effective. See Trial Status Date Rules .
   Why Study Stopped	If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study has ended or is not currently accruing. You can update your comment only for trials that are Temporarily Closed to Accrual. Optionally, enter any comments regarding the trial status.
   Trial Start Date*	Enter the date on which the trial started, or is expected to start. Indicate whether the start date is the one on which the trial is expected to start, or the date on which it actually started by selecting Anticipated or Actual. See  Trial Status Date Rules .
   Primary Completion Date*	Enter the date on which the final subject was examined or received an intervention, or the date on which that is expected to happen. Indicate whether the completion date is the one on which the trial is expected to be primarily completed, or the date on which it actually was primarily completed, by selecting Anticipated or Actual. See Trial Status Date Rules . Info title Exceptions Primary Completion Dates are optional in the following cases: For non-interventional trials. For DCP trials, if you select N/A as the type. In both cases, the system excludes such trials when submitting XML documents to ClinicalTrials.gov.
   Completion Date	Enter the final date on which data was (or is expected to be) collected for the trial. Indicate whether the completion date is the one on which the trial is expected to be completed, or the date on which it actually was completed, by selecting Anticipated or Actual. See Trial Status Date Rules .

4. Click Save.
   The system displays a confirmation message if the status transition you added or updated conforms to the rules in Trial Status Transitions. Otherwise it displays warning and/or error messages.
   
5. If the system displays warning and/or error messages, click the History icon, and follow the instructions in Abstracting Trial Status Histories to correct them.

Trial Status Record Abstraction for Super Abstractors

How to Abstract Trial Status Information

1. Follow the instructions for abstracting Trial Statuses in Trial Status Abstraction for Admin Abstractors.
   Because you can abstract a trial status without checking it out, the system checks out the trial to you. This ensures that you do not invalidate previously validated records.
   If the system detects errors, it displays the Trial Status Validation window.
     
   
2. Click Trial Status History and follow the instructions in Abstracting Trial Status Histories .