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

In addition to automatically deleting non-applicable visits for protocol amendments, visits that are scheduled and deemed non-applicable by early termination are deleted. Visits that are not scheduled through a template are not deleted. The following rules apply to deleting the appropriate visits:

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

   When the Status field of a subject is changed to Early Terminated and the Early Terminated date is populated, all future visits are deleted. Future visits are visits with a Due date and an Early Terminated date.

2. Delete non-applicable, scheduled visits after a subject fails screening.

   When the Status field of a subject is changed to Screen Failure and the Screen Failure date is populated, all future visits are deleted. Future visits are visits with a Due date and a Screen Failure date.