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 |
|
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
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.)
On the Validation menu, click Trial Status. The Trial Status page appears.
Screenshot TBD. |
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Why Study Stopped | If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study has ended or is not currently accruing. |