New dataset in Oracle Clinical One Analytics

Sponsor users can now work with a brand new dataset in the Oracle Clinical One Analytics application.

Particularly useful to clinical supply managers, the brand new Unblinded Kits dataset offers users the ability to create custom reports based on all the kits-related data that is collected within Oracle Clinical One Platform. This way, a clinical supply manager (or any other sponsor user with the appropriate permission) can track shipments, lots, and kit statuses within their studies.

Details for user administrators and global user managers

The new permission (Run the Unblinded Kits Dataset) is associated with the ability to work with the Unblinded Kits dataset. As a user administrator or global user manager, you can assign this permission to any sponsor user who must have the ability to work with this dataset in Oracle Clinical One Analytics. Additionally, you must know that this new permission is included, by default, in the following predefined template study roles:

• Clinical Supply Manager
• View Only for Unblinded Support Users
• Statistician

Details for clinical supply managers and other sponsor users

The Unblinded Kits dataset contains additional metadata about your study, sites, depots, and kits, giving you not only the ability to have better control over your supply system, but also the opportunity to answer numerous questions related to supply elements within your studies (kit inventory statuses, shipment statuses, kit dispensation or lot data, and many more).

More details on the exact data elements included in this dataset can be found in the Oracle Clinical One Platform Analytics User Guide.

Before working with this new feature

If you're a sponsor user working with Oracle Clinical One Analytics, there's another change that you should be aware of. To properly use and filter data into a custom report, you must know that we are now identifying the required folder of each specific dataset. This way, you can determine what data element of a given dataset is required to create a proper report in Oracle Clinical One Analytics.

Here is a list of all required folders corresponding to each dataset:

• The Blinded Subject Events dataset: The Event folder.
• The Queries dataset: The Query folder.
• The Subject dataset: The Subject folder.
• The Subject Forms dataset: The Form folder.
• The Subject Form Items: The Item folder.
• The Unblinded Subject Events dataset: The Event folder.
• The Unblinded Kits dataset: The Kits folder.

Already working in a live study?

As soon as the upgrade for this release is complete, whether you are working in a new or existing study, you can start your work with this new data set (as long as your organization is enabled and ready to use Oracle Clinical One Analytics). For more information on this new data set, reach out to your Oracle project manager.