Page History

Ensure that the relationships between statuses and dates follow the rules provided in the tables and diagrams that follow.

How to Review Trial Status Details

1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.

3. On the Validation menu, click Trial Status. The Trial Status page appears.
   

4. To view trial status information previously recorded, in the upper right corner of the Trial Status section, click History.

5. 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 v4.420170331 Trial Status Definitions - Include v4.420170331
   Current Trial Status Date*	Enter the date on which the current trial status became effective.
   Why Study Stopped	If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study has ended or is not currently accruing.
   Trial Start Date*	Enter the date on which the trial started, or is expected to start. See Trial Status Rules. 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.
   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 complete, or the date on which it actually completed, by selecting Anticipated or Actual. 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 complete, or the date on which it actually completed, by selecting Anticipated or Actual. HTML Comment hidden true See https://prsinfo.clinicaltrials.gov/definitions.html.

6. If you made any changes, click Save.
7. If the system displays errors and/or warnings, correct them according to the instructions in Abstracting Trial Status Histories.