New datasets to track sign, verify, freeze, and lock actions

You can now track Sign, Verify, Freeze, and Lock (SVFL) actions and their audit history with the three new datasets available in Oracle Clinical One Analytics.

To track SVFL actions applied to an object (visit, form, or question), the following datasets are introduced as part of Oracle Clinical One Platform 25.2.1:

• Subject Event SVFL dataset
• Subject Form SVFL dataset
• Subject Item SVFL dataset

These datasets provide current and historical data about SVFL actions applied to visits, forms, and form items, respectively.

Details for user administrators and global user managers

The new permission Run Data Management Actions Datasets, has been added in Oracle Clinical One Platform to grant access to all three SVFL datasets. As a user administrator or global user manager, you can assign this permission to any sponsor user who requires the ability to work with these datasets in Oracle Clinical One Analytics.

This new permission is also now included in the following predefined template study roles:

• Clinical Research Associate (CRA)
• Medical Monitor
• Data Manager
• View Only for Unblinded Support

Details for data managers, CRAs, and other sponsor users

Note:

For repeating form instances, the Subject Form SVFL dataset now tracks instance-level statuses for all newly collected data, providing complete audit points going forward. Historical data is different: past repeating form instances don't include instance-level SVFL statuses, so you may see gaps when reviewing older records. Item-by-item actions are still tracked for the data itself, as well as at the visit level, but detailed status information at the form-instance level is only available for new data collected after this update.

You can rely on full-instance level status and audit history for repeating forms from now on, but historical repeating form data will not retroactively include these details.

The SVFL datasets provide not only the current status, but also historical data about the SVFL actions applied to the given object over time. With these, data managers, auditors, and other sponsor users with appropriate permissions can now review when SVFL actions took place in a study and, more importantly, when any of them were undone and why. For example, if a form is currently unverified, you can track when it was originally verified and by whom, and also see what happened next that made it become unverified.

Additionally, with the SVFL datasets it is now possible to get detailed information about signatures at the same granular level (visit, form, or question). For instance, you can get details on the timestamp and specific user who signed the given object, metrics about how many times an investigator signs and unsigns objects within a casebook, or even retrieve the ALCOA audit details about how a signature changed.

Remember that to properly visualize data when working with any dataset, you must include at least one element from the folder listed as required. When working with the SVFL datasets, include data elements from the Item (Required), Form (Required) or Event (Required) folder (respectively) on your custom reports, in addition to data elements from the Actions folder, and start analyzing your study's SVFL actions data at the visit, form or item levels.

Already working in a live study?

As soon as this release is available, you can be assigned with the new Run Data Management Actions Datasets permission and access these datasets. With them, you will be able to see all audits for the SVFL actions, including those that were applied to questions, forms, and visits before the dataset was introduced.

You can find additional information regarding the SVFL datasets and their data elements, in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade.