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The following table provides the definitions of each of the statuses that occur during the course of the trial processing work flow. The diagram (after the table) illustrates the work flow so that you can see the relationships between the trial statuses.

Trial Processing Status

Definition

All

Any processing status.

Submitted

Original trial submitted but not validated.

Amendment Submitted

Amendment submitted but not validated.

Accepted

Trial passed validation.

Rejected

Trial did not pass validation.

These trials are displayed in PA but not in trial search results in the Registration application.

Abstracted

Trial has been abstracted.

Verification Pending

Trial has been abstracted, and the Trial Summary Report (TSR) has been sent to the trial submitter for abstraction verification.

Abstraction Verified Response

Submitter has verified the abstraction as per the TSR, and has returned feedback to the CTRO within five business days after receiving the TSR.

(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of Personnel Management's list of Federal Holidays.)

Abstraction Verified No Response

Submitter has not responded or returned verification feedback to the CTRO within five business days after receiving the TSR.

On-Hold

Trial has been delayed, or there is not enough information to process the submission.

Submission Terminated

Trial processing has been terminated in PA. (For example, a Registration application user may have requested termination.) These trials are displayed in PA but not in trial search results in the Registration application.

Submission Reactivated

Trial processing has resumed in PA.

Diagram showing workflow for recording trial milestones

 

 

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