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Siebel Life Sciences Guide > Setting Up and Carrying Out a Clinical Trial > End-User Procedures >

Updating a Protocol Version at a Site

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When a protocol is revised mid-study, you need to update:

The subject visit template version associated with the site.
The visit schedules of any subjects already in the study.

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

Navigate to the Site Management screen.
From the Show drop-down list, select My Sites.
In the Sites list, select the site for which you want to apply a new version of the visit template.
Enter the new version of the subject visit template in the Version field.

Make sure that the new version is active and that you enter the IRB Approval Date for the version.

For instructions on editing the Version field, see Step 5.

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

Navigate to the Site Management screen.
In the Sites list, select the site for which you want to update subject visits.
Click the Subjects view tab.
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."

Navigate to the Subjects screen, and select the enrolled subject whose schedule you want to update for the revised subject visit template.
Click the Visits view tab.
Enter the informed consent date for the newer version as described in Step 3.
In the Subjects form, click Enroll, and click OK in the Enrollment dialog box.

Visits for the new protocol are appended to the Visits list.

Edit the Visit records.

Typically you would delete:

Future-scheduled visits from the original subject visit template version.
Past-scheduled visits from the new subject visit template version.

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

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