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This section The following table provides the definitions of each of the statuses that occur during the course of the trial processing work flow. It also The diagram (after the table) illustrates the work flow so that you can see the relationships between the trial statuses.
Trial Processing Status | Definition | ||||||
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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.
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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. |
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