Applying Protocol Amendments to Sites and Clinical Subjects

When you revised a protocol mid-study, 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.

Applying Revised Subject Visit Templates to Sites

This topic describes how to apply a new version of the subject visit template to a site when you revise a protocol mid-study. When you activate the new version of the subject visit template at the site, the Schedule button is enabled in the Subjects screen.

To apply a revised subject visit template to a site  

1. Navigate to the Site Management screen, then the Protocol Site List view.

2. In the Protocol Site list, select the site to which you want to apply a new version of the subject visit template.

3. In the Versions field, click the select button and complete the following steps:

   1. Select the new version of the subject visit template.

   2. Enter a date in IRB Approval Date field for the new version.

   3. Select the Active field for the new version.

   4. Click OK.

Applying Revised Subject Visit Templates to Clinical Subjects

This topic describes how to apply a new version of the subject visit template to a subject when you revise a protocol mid-study. When you activate the new version of the subject visit template at the site, the Schedule button is enabled in the Subjects screen.

To apply a revised subject visit template to 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. Complete one of the following steps:

   • To update the subject visit templates for all subjects at the site, click Apply Version to All.

     For all subjects at this site, except for those subjects with a Status field value of Early Terminated or Completed, the value in the Informed Consent Dates field is cleared, and the record for the new, active version of the template is selected in the dialog box for the Informed Consent Dates field.

   • To update the subject visit templates for some subjects at the site, select the subject records, and click Apply Version to Selected.

     For the selected subjects, except for those subjects with a Status field value of Early Terminated or Completed, the value in the Informed Consent Dates field is cleared, and the record for the new, active version of the template is selected in the dialog box for the Informed Consent Dates field.

5. In the Subjects list, drill down on the screening number field of the enrolled subject whose schedule you want to update for the revised subject visit template.

   The Visits view of the Subjects screen appears.

6. In the Subjects form, complete the following steps to enter the informed consent date for the new version:

   1. Click the select button in the Informed Consent field to open the Informed Consent Dates dialog box.

   2. Enter an informed consent date for the new version, and click OK.

7. Click Schedule, and complete the following steps:

   1. Enter the Schedule Date.

      A message appears asking 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 occur 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.

        The non-applicable visits are deleted.

      • Click Cancel.

        The new visits for the new protocol version are appended to the existing Visit Plans 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.

      The Subject Visits record updates as follows:

      • All the visits in the new active subject visit template are copied to the Visit Plans 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 in the subject visit template and the start date 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".

Rules for Applying Protocol Amendments

If you choose Cancel in response to the delete uncompleted visits from the old version and completed visits from the new version dialog, then a new set of visits is created and added to the visits already created from prior versions.

If you choose OK, then a new set of visits is created, the two sets of visits are compared, and the non-applicable visits are deleted when the following conditions are satisfied:

1. The subject Informed Consent date is used for the new version as a cut-off date for transitioning from the old version to the new version.

2. Equivalent Visits are those visits that have the same Visit Name.

3. For an old visit (created from the old template version) with a Completed date:

   1. If the Completed date is earlier than the Informed Consent date, then the old completed visit remains intact, and the corresponding visit from the more recent amended version is deleted. In other words, visits under the old version that are completed before an amendment takes effect are preserved, and the equivalent visits from the new version are deleted.

   2. If the Completed date is later than or equal to the Informed Consent date, then the following rules apply:

      • If the Due date of the corresponding new visit is earlier than the Informed Consent date, then the old completed visit remains intact. In other words, visits that are scheduled under the old version to complete before an amendment occurs but are actually completed later are also preserved. The equivalent visits from the new version are deleted.

      • If the Due date of the corresponding new visit is later than or equal to the Informed Consent date, then the visits from the old version are deleted, but the completed dates are copied to the equivalent visits from the new version. In addition, all child activities of the completed visits are set to Completed and have the same completed date of the parent visit. This rule applies in situations where the subject already switched to the new version before Siebel Clinical is setup in time to handle such a scenario. In such a case, the visit records generated under the old version are marked Complete instead of the visits from the new version.

4. For an old clinical visit without a Completed date:

   1. If the Due date is later than or equal to the Informed Consent date, then the visit generated from the old version of the subject visit template is deleted. In other words, future visits generated from the old version that are not yet completed are deleted, and their equivalent visits from the new version are preserved.

   2. If the Due date is earlier than the Informed Consent date, then the visit from the old version remains intact. In other words, visits under the old version that are not completed (these visits are presumably the visits that a Subject missed in the past) are preserved, and the equivalent visit from the new version is deleted.

5. For a new visit generated under the new template version:

   1. If the Due date is earlier than the Informed Consent date, then the new visit is deleted.

   2. If the Due date is later than or equal to the Informed Consent date, then the new visit remains intact, although it might still be deleted using the aforementioned rules.

Rules for Deleting Subject Visits When Deemed Non-Applicable by Early Termination

In addition to automatically deleting non-applicable visits for protocol amendments, visits that are scheduled and deemed non-applicable by early termination are deleted. Visits that are not scheduled through a template are not deleted. The following rules apply to deleting the appropriate visits:

1. Delete non-applicable, scheduled visits after a subject terminates the study.

   When the Status field of a subject is changed to Early Terminated and the Early Terminated date is populated, all future visits are deleted. Future visits are visits with a Due date and an Early Terminated date.

2. Delete non-applicable, scheduled visits after a subject fails screening.

   When the Status field of a subject is changed to Screen Failure and the Screen Failure date is populated, all future visits are deleted. Future visits are visits with a Due date and a Screen Failure date.