Lock and unlock multiple subjects simultaneously

Sponsor users can lock and unlock multiple subjects at the same time to safeguard data integrity and prevent unintended changes, ensuring studies stay on track.

This feature offers the following benefits:

• Enables sponsors to simultaneously lock multiple subjects - either all subjects or a subset of subjects within a site or across all sites - saving time and effort as key study milestones approach.
• Reduces manual effort by eliminating the need to lock subjects one at a time, allowing users to focus on other critical tasks.
• Facilitates faster data readiness for interim and final analyses by accelerating the subject lock process.
• Ensures subject data is finalized and no further changes are allowed, supporting both interim and final locks with greater ease.

Before working with this feature

No new permission or role is introduced along with this feature. However, as a user manager in your study, you must ensure that the appropriate sponsor users are assigned with the existing Lock subject data entered at a site permission.

Sponsor users who are not assigned this permission will not see the new Data Management view and won't be able to switch between this view and the new Subject Overview view.

Details for sponsor users

If you're a sponsor user responsible for locking subjects in a study, here's what you need to know:

• On the Subjects page, you can now switch between two different views: the Subject Overview view and the Data Management view.
  • On the Subject Overview view, you get to see all subjects at a site, as well as their visit schedule. You can continue filtering subjects and adding new subjects.
  • On the Data Management view, you can now lock and unlock multiple subjects or multiple visits for the same subject.
• On the Data Management view you can filter subjects by country, site, and status, as well as use the following new filters: All Visits Complete, Queries, Verification, Signature, and Locked. Moreover, you can sort subjects on their displayed columns.
• On the Subject Overview view you can continue filtering subjects by country, site, status, review, and safety case status.
• On the Data Management view, you can select multiple subjects then lock or unlock them in bulk. To do so, you can filter them appropriately or search for their subject numbers, select all of them, and then select Lock or Unlock from the Manage drop-down.
• While subjects or visits are being locked, you can still manage other subjects and their data.

Other user experience updates

Other new design changes are introduced with this release that may impact your workflows. Here's what else may be new for you in the User Interface (UI):

• You can now perform all query management activities on the new Queries page, located in the top menu bar. It opens the same page as the previous Query List button.
• On the Subject Overview view, the Add Subject button is now located in the top-right corner of the page.
• The Manage Subject button is now called Manage and remains located along the top of the Subjects page, on the Subject Overview view.
• Upon selecting a subject, you no longer see the following options on the Manage drop-down, since those actions are now available on the Data Management view only: Lock a Subject or Unlock a Subject.
• On the Subjects page, using the Subject Overview view, you can see the number of subjects at a specific site and continue managing subjects the way you used to. Your options to filter through subjects remain the same.
• On the Subject Overview view, only visits that have been started, skipped, or that occurred before a started visit are shown. This may include visits marked as Not Started, except for those at the end of the visit schedule, when a Data Intake integration needs to send data into a later scheduled visit. Adverse events are still displayed in the same column.
• Filters set on the Subject Overview view and the Data Management view are not shared, but each view will remember its own filters when you return to it.

You can find additional information about this new feature in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.