How Termination Visits Interact With DCM Tracking

If a patient withdraws from a study earlier than expected, visits scheduled after the date of early termination—that is, where dates and visit numbers are greater than the early termination visit's—are no longer expected. You can indicate that early termination has occurred in two ways:

  • Create an early termination visit. Any DCM logged in at that visit signals that early termination has occurred.

  • Create a DCM of type termination. When this DCM is logged in at any visit, that visit is considered to be the early termination visit.

The following table explains how early and normal termination visits affect DCM tracking.

Table 3-2 Termination and DCM Tracking

Termination Type Description Effect on DCM Tracking

Early Termination

A patient leaves the study earlier than expected; an Early Termination DCM, or Early Term type of visit, is entered.

A visit—including a normal termination—is no longer expected if its projected date comes after the DCM Date of the Early Termination form. However, any other forms scheduled for an early termination visit are expected by the system.

Normal Termination

A patient completes the study, including the normal termination visit; a Normal Termination DCM, or Normal Term type of visit, is entered.

You can schedule some visits after the normal termination visit; scheduled visits after normal termination are projected in the same way as any other scheduled visit if an early termination has not occurred. A normal termination visit indicates that an early termination can no longer occur.