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11 | Withdrawn | Withdrawn | Terminal | Study halted prematurely, prior to enrollment of first participant.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). |
How to Complete the Status/Dates Section
In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Instructions for recording Site Recruitment Statuses/Dates
Field Label | Description/Instructions |
---|---|
Site Recruitment Status* | Select the current stage or state of the trial or study. |
Site Recruitment Status Date* | Enter the date on which the current trial status became effective. See Trial Status Rules. |
Date Opened for Accrual | If appropriate, enter the date on which the trial was opened for accrual. |
Date Closed for Accrual | If appropriate, enter the date on which the trial was closed for accrual. |