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.