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.Â
Current trial status definitions
CTRP Trial Status Values | ClinicalTrials.gov Trial Status Values | Definition |
|---|---|---|
In Review | Not yet recruiting | Trial is currently under IRB review. |
Withdrawn | Withdrawn | Trial has been withdrawn from development and review prior to enrollment of the first participant. |
Approved | Not yet recruiting | Trial has been approved, but is not yet recruiting or enrolling participants. |
Active | Recruiting | Trial is open for accrual and enrollment. |
Enrolling by Invitation | Enrolling by Invitation | Participants are being (or will be) selected from a predetermined population. |
Temporarily Closed to Accrual | Suspended | Participant recruitment or enrollment has been halted prematurely but may resume. Participants already on trial continue to receive intervention. |
Temporarily Closed to Accrual and Intervention | Suspended | Participant recruitment or enrollment has been halted prematurely but may resume. Participants already on trial do not receive intervention. |
Closed to Accrual | Active, not recruiting | Trial has been closed to participant accrual, but trial is ongoing (i.e., participants continue to receive treatment and/or examination). |
Closed to Accrual and Intervention | Active, not recruiting | Trial has been closed to participant accrual. Participants already on trial do not receive treatment, but continue to be monitored for endpoints such as long term survival. |
Administratively Complete | Terminated | Participant recruitment or enrollment has been halted prematurely (for example, due to poor accrual, insufficient drug supply, IND closure, etc.), and will not resume. Participants already on the trial do not receive further treatment or examination. |
Complete | Completed | Trial has been closed to accrual and follow-up. Participant treatment/intervention has been completed and participants are no longer monitored for trial endpoints (i.e., last patient's visit has occurred). The trial has met its objectives. |
