Creating a New Study Plan

Create a new study plan when you have already baselined (permanently recorded), a study plan, but need a new one to meet changed conditions. To create a new study plan, from the Design menu, select Studies, and choose Study and Site Plans for the Maintain Study and Study Site Plans window. Click the Create New Plan button. A new plan record appears, which inherits many of the values of the previous plan. The new record also has an incremented plan number (Plan #), a newly calculated Actual Enrollment value, and new Effective and Superseded Dates.

Each time you create a new plan, the system resets each of these fields to the current date: the Superseded Date for the old plan and the Effective Date for the new plan. It sets the Superseded Date for the new plan to 15-AUG-3501. Viewing the Effective and Superseded Dates fields of each of the study plans reveals the time periods over which the prior plans were effective.