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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).

 

Current trial status definitions

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CTRP Trial Status Values

ClinicalTrials.gov Trial Status Values

Definition

01

In Review

Not yet recruiting

Participants are not yet being recruited.

11

Withdrawn

Withdrawn

Study halted prematurely, prior to enrollment of first participant.

02

Approved

Not yet recruiting

Participants are not yet being recruited.

03

Active

Recruiting

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

Study halted prematurely but potentially will resume.

09

Temporarily Closed to Accrual and Intervention

Suspended

Study halted prematurely but potentially will resume.

05

Closed to Accrual

Active, not recruiting

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

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

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

07

Complete

Completed

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