Status Transition Rules

The table and diagram below provide rules for ensuring that you record valid transitions between trial statuses and participating site statuses.

Trial Status Flow Relationships

A trial can proceed from this status…	Directly to this status	Or to this status
In Review	Approved Withdrawn	Active/Enrolling by Invitation This can occur when the trial has been Approved and is Active/Enrolling by Invitation on the same day
Approved	Active/Enrolling by Invitation Withdrawn	NA
Active/Enrolling by Invitation	Closed to Accrual	Temporarily Closed to Accrual Temporarily Closed to Accrual and Intervention Closed to Accrual and Intervention Administratively Completed Completed Withdrawn
Closed to Accrual	Closed to Accrual and Intervention	Completed Administratively Completed
Closed to Accrual and Intervention	Completed Administratively Completed	NA
Temporarily Closed to Accrual	Temporarily Closed to Accrual and Intervention	Active/Enrolling by Invitation Closed to Accrual Closed to Accrual and Intervention Administratively Completed
Temporarily Closed to Accrual and Intervention	Administratively Completed	Active/Enrolling by Invitation Closed to Accrual Closed to Accrual and Intervention

The diagram below illustrates the flow and transitions among trial statuses. The system records the statuses in the order indicated by the arrows. Double-ended arrows indicate that a transition between statuses can be recorded in either order. For example, a status can transition from Active/Enrolling by Invitation to Temporarily Closed to Accrual and Intervention, or conversely, from Temporarily Closed to Accrual and Intervention to Active/Enrolling by Invitation.

Diagram showing the links between trial statuses as described in the text
Trial Status Transitions

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