TrialKit has a powerful feature called Versioning to make compliant and controlled changes to studies without needing to pause the study. Study subjects can run on multiple versions in parallel. For example, subjects who have already withdrawn from a study would not need to have study design changes applied to their data, so they could remain on a prior version, while the active subjects are migrated to a newer version.
When a new study has versioning enabled, a Version tab will appear on the study configuration page.
New studies will automatically have one version in place with In Development status.
Publish study versions
When the study has been built, tested, and approved, the study version is ready to be published.
Publishing a study merely prevents the forms and visit schedules from being changed for that particular version.
It does not give sites the ability to begin enrolling subjects. Read here on how to allow sites to begin enrolling.
To publish a study, select the icon highlighted in the image below.
Important: After a version has been published, it's necessary to include any applicable study sites in that version. Read more on Version Management.
Create/edit study versions
After the latest version of a study has been published, changes cannot be made to forms or visit schedules until there is a new development version in place. To add a new development version, open the study configuration, and follow the steps below.
Complete the section highlighted in the image below.
Selecting the "Add New Version" button will populate the table to the right.
Important: Be sure the "Effective Date" is later than the date of the previous version.
Once the Version Manager is used to add at least one site to the new version, the option to Delete that version will go away.
Managing Versions - Site and Subject Migration
The system limits studies to having one Development version at a time. As each version is published, a new development version can be created as described in the previous section.
The Version Manager is used to control which sites and subjects are part of specific study versions. This is also where subjects are migrated from older study versions to newer ones as changes are made to the study design.
The Version Manager is found under the Study menu, based on permissions/access to Version Control
Including a site in a study version
Select which version of the study to manage. The choice made will indicate if it is a published version or a development version
Check the box next to any site that needs to be included in the current selected version. This will place the site on the new version moving forward (any new subjects added). Continue reading in the next section about migrating existing subjects.
If the version is in development, only Administrative site types can be included.
Migrating existing subjects to a new version
To migrate existing subjects, click the “Migrate Subjects” link (Don’t worry, this will not perform any actions). A list of subjects will open for that site. From the table, specific subjects can be selected or All subjects can be migrated to the version which is currently selected at the right side of the screen.
Migrating All subjects will create a background job so the user does not need to wait for the process to finish. Migrating selected subjects will require the user to wait for the system to process those subjects.
Choosing to run edit checks with the migration will cause the system to perform a re-save on every record throughout the study so it can process the edit checks. For large-volume studies this can be quite time-consuming depending on the total number of records across all subjects. It’s normally advised to migrate all subjects without running edit checks or conditional actions. Once migration is complete, use the re-run edit checks function to choose only specific/new edit checks that need to be run.
If migrating All subjects, the user will receive a confirmation email upon job completion.
“Diff” View the difference, or changes made, between versions
As new versions of the study are created, the system will track those changes made to the subject forms.
These changes can be recorded using a customized study form.
Click on the Version tab
Clicking the Diff link will display the Version Difference page.
The Version Difference page displays the differences that exist between a Source Version and a Destination Version as shown in the figure below.
Versioning applies only to the data being collected. In other words, form elements themselves. Changes made to user roles or how often forms are collected are not under the enforcement of version control.
This is exportable from the right side of the page:
Un-publish study versions
The study can also be unpublished as long as there are no subjects on that version and no sites are part of that version (this can be checked in the Version Manager). If those two rules are met, a link will appear like the one highlighted below. In this way, a study can potentially be reversed all the way back to a single version. This is particularly helpful for new studies that were copied from a previous study that had multiple versions.
Delete study versions
Deleting a study version may be necessary particularly on copied studies where a builder may wish to begin with a single study version. The delete link will appear as shown below if there are no subjects in that version, no sites are part of that version, and the version has been unpublished.
