After a new version is created, and sites have been included in that version, the system will include any future enrolled subjects in that version. Any subjects that already existed at a site will remain on a prior version unless they are migrated to the more recent version.
Important notes when migrating subjects:
- All changes made to the study will be applied. To prevent unwanted changes or data loss, please keep this in mind and consider the changes made prior to migrating subjects.
- All conditional actions on the forms will be re-run by the system unless you check the box "Do Not Run Conditional Actions" as shown in #3 below. This includes notifications and edit checks.
3) Option to Not Run Conditional Actions. This will bypass running any conditional actions or resaving of every record during migration.
For example, a single study has been initiated and has enrolled five subjects to this point. The study sponsor or owner has decided to amend the rules of enrollment. The following steps outline a typical course of action for this scenario.
1) The study administrator or other user with rights will use ‘Study Configuration – Versions’ page to add a new version to the study.
2) The system will automatically make a copy of all forms for the study. These copies will be for the new version only, and appear in the Form Builder page’s Current Forms table.
3) The user in charge of building the study forms uses the Form Builder to select the new version of the enrollment form and make the appropriate rule changes to the form.
4) If all appropriate changes have been made, the study is ready to be ‘published’ in the Study Configuration – Versions page, by selecting the icon in the ‘Publish’ column of the current versions table.
5) The user will then open the Version Manager application discussed in this document to include the appropriate sites which will be enrolling new subjects under the new rules.
6) Subjects who have already been enrolled can be migrated over to the new version so future forms that are filled out for the former subjects will be version two forms.Note: There is no need to migrate subjects out of the first version if the study sponsor calls for them to remain with the first version, or if they are no longer in the study.