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Current trial status definitions

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CTRP Trial Status Values

ClinicalTrials.gov Trial Status Values

Definition

01

In Review

Not yet recruiting

Trial is currently under IRB reviewParticipants are not yet being recruited.

11

Withdrawn

Withdrawn

Trial has been withdrawn from development and review Study halted prematurely, prior to enrollment of the first participant.

02

Approved

Not yet recruitingTrial has been

approved, but is not yet recruiting or enrolling participantsParticipants are not yet being recruited.

03

Active

RecruitingTrial is open for accrual and enrollment

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

04

Enrolling by Invitation

Enrolling by Invitation

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

08

Temporarily Closed to Accrual

Suspended

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

09

Temporarily Closed to Accrual and Intervention

Suspended

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

05

Closed to Accrual

Active, not recruitingTrial

has been closed to participant accrual, but trial is ongoing (i.e., participants continue to receive treatment and/or examination)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 recruitingTrial 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

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

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

07

Complete

Completed

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.