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Comment: Added column based on email conversation with Michael Izbicki.

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. 

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In the definitions below, leave the passive voice as it is. Also, leave the definition of Closed to Accrual and Intervention as it is, even though it seems to contradict the status name. Refer to David Loose's  4/4/17 comment in Teamwork, "we are intentionally copying the corresponding ClinicalTrials.gov status definitions, as they are." (https://fnlcr.teamwork.com/#tasks/6016357?c=2604303). I think his definitions came from https://prsinfo.clinicaltrials.gov/definitions.html.

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

 

Current trial status definitions

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CTRP Trial Status Values

ClinicalTrials.gov Trial Status Values

Status Category

Definition

01

In Review

Not yet recruitingTrial is currently under IRB review.

Review

Participants are not yet being recruited.

11

Withdrawn

Withdrawn

Terminal

Study halted prematurely, Trial has been withdrawn from development and review prior to enrollment of the first participant.

02

Approved

Not yet recruitingTrial has been approved, but is not yet recruiting or enrolling participants.

Review

Participants are not yet being recruited.

03

Active

RecruitingTrial is open for accrual and enrollment.

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 Participant recruitment or enrollment has been halted prematurely but may potentially will resume. Participants already on trial continue to receive intervention.

09

Temporarily Closed to Accrual and Intervention

Suspended

Open

Study Participant recruitment or enrollment has been halted prematurely but may potentially will resume. Participants already on trial do not receive intervention.

05

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

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

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.

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

TerminatedParticipant 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.

Terminal

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

07

Complete

Completed

Terminal

Trial has been closed to accrual and follow-up. Participant treatment/intervention has been completed and The study has concluded normally; participants are no longer monitored for trial endpoints (i.e., last patient's receiving an intervention or being examined (that is, last participant’s last visit has occurred). The trial has met its objectives.