Siebel Clinical Trial Management System Guide > Administering Clinical Subjects and Clinical Visits > Applying Protocol Amendments to Sites and Clinical Subjects >

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 on top of 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's Informed Consent date is used for the new version as a cut-off date for transitioning from the old version to the newer version.
2. Equivalent Visits are those that have the same Visit Name.
3. For an old visit (created from the old template version) that has the Completed date filled in:
   1. If the Completed date is less than the Informed Consent date, then the old completed visit is left 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 greater than or equal to the Informed Consent date, then the following rules apply:
      • If the Due date of the corresponding new visit is less than the Informed Consent date, then the old completed visit is left intact. In other words, visits that are scheduled under the old version to complete before an amendment takes place 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 greater 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 has already switched to the new version before Siebel Clinical is setup in time to cater for 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 that does not have the Completed date filled in:
   1. If the Due date is greater 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 have not yet been completed are deleted, and their equivalent visits from the new version are preserved.
   2. If the Due date is less than the Informed Consent date, then the visit from the old version is left intact. In other words, visits under the old version that have not been completed (those are presumably the visits that a Subject has 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 less than the Informed Consent date, then the new visit is deleted.
   2. If the Due date is greater than or equal to the Informed Consent date, then the new visit is left intact, although it could still be deleted using other rules specified above.