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| 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 tables and diagrams that follow.Include Page
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 |
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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 |
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- Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial 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.
HTML Comment hidden true Screenshot TBD.
- To view trial status information previously recorded, in the upper right corner of the Trial Status section, click History.
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. Valid values are as follows:
Include Page Trial Status Definitions - Include 20170331 Trial Status Definitions - Include 20170331For 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If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study has ended or is not currently accruing.
In the various date fields, specify dates as they occur according to the rules specified in Status Rules for Trial Dates. The following table describes the fields. In this table, an asterisk (*) indicates a required field and an asterisk within square brackets ([*]) indicates a conditionally required field.
Include Page Trial Date Step - Include 20170822 Trial Date Step - Include 20170822 Field Label
Description/Instructions
Trial Start Date*
Enter the date on which the trial started, or is expected to start.
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.
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. Otherwise, Primary Completion Dates are required.
Completion Date
Enter the final date on which data was (or is expected to be) collected for the trial.
HTML Comment hidden true HTML Comment hidden true - Indicate whether each date you entered is Actual or Anticipated, according to the rules specified in Status Rules for Trial Dates.
- If you made any changes, click Save.
- If the system displays errors and/or warnings, correct them according to the instructions in Abstracting Trial Status Histories.
