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Validate the trial status for Complete trials only.

 Trial Status validation does not pertain to Abbreviated trials.

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

Trial status refers to the current stage or state of participant/patient enrollment in a clinical trial relative to other stages. CTRP uses the same statuses at the trial level and at the participating site level. The following table lists the valid trial statuses used in CTRP and maps each value to the corresponding ClinicalTrials.gov-defined recruitment value. 

For information on Expanded Access trial statuses, refer to Expanded Access Statuses

 

Current trial status definitions

#

CTRP Trial Status Values

ClinicalTrials.gov Trial Status Values

Status Category

Definition

01

In Review

Not yet recruiting

Review

Participants are not yet being recruited.

11

Withdrawn

Withdrawn

Terminal

Study halted prematurely, prior to enrollment of first participant.

02

Approved

Not yet recruiting

Review

Participants are not yet being recruited.

03

Active

Recruiting

Open

Participants are currently being recruited, whether or not any participants have yet been enrolled.

04

Enrolling by Invitation

Enrolling by Invitation

Open

Participants are being (or will be) selected from a predetermined population.

08

Temporarily Closed to Accrual

Suspended

Open

Study halted prematurely but potentially will resume.

09

Temporarily Closed to Accrual and Intervention

Suspended

Open

Study halted prematurely but potentially will resume.

05

Closed to Accrual

Active, not recruiting

Closed

Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled.

06

Closed to Accrual and Intervention

Active, not recruiting

Closed

Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled.

10

Administratively Complete

Terminated

Terminal

Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

07

Complete

Completed

Terminal

The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred).

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.

  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 a list of valid values, refer to Trial Status Values in the CTRP and ClinicalTrials.gov.

    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. In the various date fields, specify dates as they occur according to the rules specified in CTRP System Rules for Study Status and 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.

    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.

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