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Rules for Deleting Visits Deemed Non-applicable by Early Termination

In addition to automatically deleting non-applicable visits per protocol amendments, the application applies the following automation rules to delete visits deemed non-applicable by early termination.

1. Delete non-applicable visits after a subject terminates the study.

   When the Status of a Subject is changed to Early Terminated and the Early Terminated date is filled in, all the remaining visits are deleted. The remaining visits are identified as visits with Due date > Early Terminated date.

2. Delete non-applicable visits after a Subject fails screening.

   When the Status of a Subject is changed to Screen Failure and the Screen Failure date is filled in), all future visits are deleted. Future visits are defined as visits with Due date > Screen Failure date.