Trial Summary Reports (TSRs) keep submitters and/or principal investigators informed about the progress of their trials throughout the processing life cycle. They contain all the submitted, abstracted, and amended data elements in the system to date.
The system generates TSRs upon the document specialist’s request via the trial search functionality, via the View TSR option on the Trial Overview menu, and via abstraction validation. TSRs are also generated and emailed to the submitter when the Trial Summary Report Sent Date milestone is recorded.
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 |
---|---|---|
Send TSR/TSR Sent Date | CTRO |
|
Receive TSR feedback/Submitter TSR Feedback Date | Submitter (with feedback) | CTRO |
Trial amendments follow a similar system of reporting and feedback as the original submission, though the TSR includes additional amendment-related data.