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Applying Revised Subject Visit Templates to Clinical Subjects

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 a clinical subject

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

   New records for the new version of the template are created in the Informed Consent Dates field for all subjects in this site except for those subjects with a status of Early Terminated or Completed.

5. Navigate to the Subjects screen, and drill down on the screening number field of the enrolled subject of the schedule you want to update for the revised subject visit template.
6. Navigate to the Visits view.
7. Enter the informed consent date for the newer version.
8. In the Subjects form, click Schedule, and complete the following steps:
   1. 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.

   2. Complete one of the following steps:
      • Click OK. If you click OK, then the non-applicable visits are deleted.
      • Click Cancel. If you click Cancel, then the new visits for the new protocol version are appended to the existing Visits list. No visits are deleted. Typically, if you click Cancel, then you can return at a later stage to the Visits list and delete future-scheduled visits from the original version of the subject visit template and past-scheduled visits from the new version of the subject visit template.

        For more information, see Rules for Applying Protocol Amendments.

        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 using 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 or Due Date equals Schedule Date plus Lead time.

        For more information, see Rules for Applying Protocol Amendments.