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Applying Protocol Amendments (End User)

When a protocol is revised mid-study, you need to apply the protocol amendments and update:

• The subject visit template version associated with the site.
• The visit schedules of any subjects who are still in the study.

To apply a new version of a subject visit template to a site

1. Navigate to the Site Management screen > Protocol Site List view.
2. In the Sites list, select the site for which you want to apply a new version of the visit template.
3. Enter the new version of the subject visit template in the Version field.

   Make sure that the new version is active by entering the IRB Approval Date for the version and checking the Active flag.

   For instructions on editing the MVG Version field, see Step 4.

To apply a new version of the subject visit template for an enrolled subject

1. Navigate to the Site Management screen > Protocol Site List view.
2. In the Sites list, drill down on the Site # 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 # 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 as described in Step 4.
8. In the Subjects form, click Enroll and click OK in the Enrollment dialog box.

   A dialog box is displayed asking you if you would like to delete non-applicable visits. 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 already been completed prior to when the template was amended.

9. Do one of the following:
   • Click No. If you click No, 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 may 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.
   • Click Yes. If you click Yes, the non-applicable visits are deleted.

NOTE:  Screening and rescreening schedules are revised in the same way, except that informed consent dates are not necessary for these types of visit.