Trial Status validation does not pertain to Abbreviated trials.

For information on trial statuses, refer to Trial Status Values in the CTRP and ClinicalTrials.gov. Ensure that the relationships between statuses and dates follow the rules provided in Status Transition Rules and the following table:

If you transition from this status...

To this status...

The system creates this status

In Review

Active, or Enrolling by Invitation

Approved

Active, or Enrolling by Invitation

Closed to Accrual and Intervention

Closed to Accrual

Active, or Enrolling by Invitation

Completed

  • Closed to Accrual
  • Closed to Accrual and Intervention

Temporarily Closed to Accrual

Administratively Completed

Temporarily Closed to Accrual and Intervention

Temporarily Closed to Accrual

Closed to Accrual

None

Temporarily Closed to Accrual

Closed to Accrual and Intervention

None

Temporarily Closed to Accrual and Intervention

Closed to Accrual

None

Temporarily Closed to Accrual and Intervention

Closed to Accrual and Intervention

None

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, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

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

    Screenshot TBD.

  4. To view trial status information previously recorded, in the upper right corner of the Trial Status section, click History.
  5. In the various status fields, specify 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. For valid ClinicalTrials.gov recruitment values, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Expanded Access Statuses.

    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    If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study has ended or is not currently accruing.

  6. Indicate whether each date you entered is Actual or Anticipated, according to the rules specified in Status Rules for Trial Dates.
  7. If you made any changes, click Save.
  8. If the system displays errors and/or warnings, correct them according to the instructions in Abstracting Trial Status Histories.