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Rules for Deleting Subject Visits When Deemed Non-Applicable by Early Termination

In addition to automatically deleting non-applicable visits for each protocol amendments, the following automation rules are applied 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, and then 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, and then Screen Failure date.