Improved performance in Oracle Clinical One Analytics with new data elements to track data reliability

The Oracle Clinical One Analytics performance is now significantly improved to handle all your study data demands. Additionally, a new dataset has been introduced to verify data consistency with Oracle Clinical One Platform.

The main improvement for this release is to make data processing incremental at a study level with automated data reprocessing. With this, we have build a data processing model scalable for all customers and their specific needs, whether they're operating a smaller or more complex study. By using a more efficient data replication model, data is now refreshed more frequently in your Oracle Clinical One Analytics datasets than before.

New dataset in Oracle Clinical One Analytics

To provide you with evidence that data is refreshed appropriately, you can now use a new data set called DH Metrics to ensure that you're looking at the latest version of your study's data in Oracle Clinical One Analytics.
  • The DH Metrics dataset is available to you in Oracle Clinical One Analytics and you don't require any new permissions to access it. If you already have any permission to view and work with datasets in the application, you will be able to see this new dataset, as well.
  • You can use this new dataset when configuring dashboards to ensure you are visualizing your study's data in an efficient manner and gain more confidence in the accuracy of the data.
  • The DH Metrics dataset contains the following folders: Study and Metrics. While the Study folder contains the standard data elements related to the study's details, the Metrics folder features new data elements that you can use to be certain of your data's consistency with Oracle Clinical One Platform. The most important metrics that you can use to test that you're looking at the latest study data are the following:
    • HEARTBEAT_CONSOLIDATION_TS indicates the date and time of the latest study data refresh that occurred.
    • IS_DATA_CONSISTENT indicates either a label of Yes or No. The Yes label validates that your Oracle Clinical One Analytics data is currently consistent with Oracle Clinical One Platform, according to when the latest study data refresh occurred (HEARTBEAT_CONSOLIDATION_TS).
  • Other data elements listed in this folder can be used together with the HEARTBEAT_CONSOLIDATION_TS and IS_DATA_CONSISTENT data elements to further confirm that your study's data is properly reflected in the Analytics application. For example, you can use a data element such as C1_INVENTORIES_MAX_VER_START to view the latest version of the table with study's inventory data that was last pulled from Oracle Clinical One Platform and DH_INVENTORIES_MAX_VER_START to see that same inventory-related data from what was last refreshed into Oracle Clinical One Analytics.

    Note:

    All data elements in the Metrics folder that begin with C1 are related to the data tables in Oracle Clinical One Platform. All data elements in the Metrics folder that begin with DH correspond to the data tables in Oracle Clinical One Analytics.

You can view all definitions of these new data elements, as well as a detailed description of the new DH Metrics dataset in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade is complete.

Other enhancements

For more information on these enhancements and the re-architecture, reach out to your Oracle point of contact.

Currently, you may observe other functionality enhancements as a result of the new data processing model. For example, see the following:
  • When there are blinded randomization numbers in your study, the Blinded Kits Dataset dataset and the Blinded Subject Events Data Set dataset display a Blinded label for the RAND_NUMBER data element, instead of 0. This is a change required for the previous release of blinded randomization numbers and will become available in your Assesment Environment (AE) and your Production environment once the new Analytics architecture is implemented. For more information on the new blinded randomization numbers feature, see Blind subject randomization numbers.
  • In the Subject Forms Dataset, a form's status is now calculated at runtime. After this upgrade, as a form's status is calculated for the first time, the audit records that are created for the form status change indicate a CREATED operation_type with the current timestamp, rather than a historical one.

    Moving forward, every time a form's status changes the audit record will indicate a MODIFIED operation_type and the timestamp will accurately reflect the time when the form status changed.

  • In the Subject Forms dataset, records of completely cleared forms are now persisted and properly displayed, allowing you to track all forms that ever existed for a subject. The records of cleared forms display with a status of New or Optional.
    When some but not all data is cleared in a completed form, its status is displayed as follows:
    • The first time the form's status is calculated, after this upgrade, its status is displayed as IN_PROGRESS.
    • Moving forward, every time that data in a completed form is cleared, its status is updated as INCOMPLETE, which is the expected behavior.
  • Also in the Subject Forms dataset, for the audit records of a form status change, the user name is now displayed as "System", as the system calculates the form status at runtime. If a user enters the last items on a form, that updates a form's status from In Progress to Complete, their username and timestamp are still stored for the item modification in the Subject Form Items dataset, but for the form status change record in the Subject Forms dataset, the user name of the user performing the action is displayed as "System".
  • Projected visit dates, in the Blinded Subject Events dataset and the Unblinded Subject Event dataset, are now displayed appropriately for all records. Previously, data related to the projected visit dates was only populated for current records and not for audit records. Also, these fields now display the date value only and not the time value.
  • Also in the Blinded Subject Events dataset and the Unblinded Subject Event dataset, the following fields are now properly populated for missing visit records, while previously they were only populated for started visits:
    • VERSION_START
    • VERSION_END
    • OPERATION_TYPE
    • USER_ID
    • USER_WID
    • USER_NAME
    • OBJECT_VERSION_NUMBER
    • SOFTWARE_VERSION_NUMBER
    • REASON
    • COMMENTS
  • The unblind date in Unblinded Subject Event dataset is now a timestamp, instead of a simple date field. This displays a proper timestamp value, for example 2025-01-02 15:08:20.000000000.
  • In the Blinded Subject Events dataset, you can now see the records of dynamic visits that were added or removed for a subject. These records display the EVENT_TYPE as Visit_Show or Visit_Hide, respectively.
  • In the Study Design Dataset, the ALLOW_ADDITIONAL_ROWS data element now displays only Yes and No values. For the cases in which this value was previously populated as Null, this now displays as No.

Parent topic: Reporting, archives, and analytics