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Applying a Revised Subject Visit Template to a Subject

This topic describes how to apply a new version of the subject visit template for a subject when a protocol has been revised mid-study. When the new version of the subject visit template has been activated at the site, the Schedule button is enabled in the Subjects view.

To apply a revised subject visit template for an enrolled subject

1. Navigate to the Site Management screen, then the Protocol Site List view.
2. In the Sites list, drill down on the Site number (#) for which you want to update subject visits.
3. Click the Subjects view tab.
4. Click Apply Active Version.

   This creates new records for the new version of the template in the Informed Consent Dates field for all subjects in this site except for those whose status is "Early Terminated" or "Completed."

5. Navigate to the Subjects screen and drill down on Screening number (#) of the enrolled subject whose schedule you want to update for the revised subject visit template.
6. Click the Visits view tab.
7. Enter the informed consent date for the newer version.
8. In the Subjects form, click Schedule.
9. Enter the Schedule Date.

   A dialog box prompts if you want to delete uncompleted visits from the old version of the subject visit template, and completed visits from the new version of the subject visit template. Non-applicable visits are those visits generated from the old template version that are scheduled to take place after the new Informed Consent Date and those visits generated by the new template version that have due dates prior to the new Informed Consent Date.

10. Do one of the following:
    • Click OK. If you click OK, the non-applicable visits are deleted.
    • Click Cancel. If you click cancel, the new visits for the new protocol version are appended to the existing Visits list. No visits are deleted. Typically, if you select this option, you can return at a later stage to the Visits list and delete:
      • Future-scheduled visits from the original subject visit template version.
      • Past-scheduled visits from the new subject visit template version.

        See Rules for Applying Protocol Amendments for more information.

        The Subject Visits record updates as follows:

    • All the visits defined in the new active subject visit template are copied to the Visits list.
    • The Visit Type, Name, Start Date, Planned, Status Tracking Visit, and Status fields are copied from the subject visit template.
    • The Planned Dates and Due Dates are calculated based on the Lead time defined in the subject visit template, and the start date defined in the Schedule Date field. The planned dates and due dates are calculated as follows:
      • Planned/Due Date = Schedule Date + Lead time.

        See Rules for Applying Protocol Amendments for more information.