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TSR feedback from the submitter or principal investigator triggers milestone events in the system. The table below shows the relationships between processing life cycle, milestone events, and TSRs.
Life Cycle Phase/Milestone | TSR Sent From | To Recipient |
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Send TSR/TSR Sent Date | CTRO |
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Receive TSR feedback/Submitter TSR Feedback Date | Submitter (with feedback) | CTRO |
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Trial amendments follow a similar system of reporting and feedback as the original submission, though the TSR includes additional amendment-related data. |