Audit Trail dashboard in Oracle Clinical One Analytics

Sponsor users can now use the Audit Trail Dashboard, available in Oracle Clinical One Analytics to easily visualize and gain an in-depth understanding of the creation, changes, and integrity of study data.

Note:

Whether you are working in a live study (and are already using Oracle Clinical One Analytics), working in a brand new study, or just starting to work with analytics, reach out to your Oracle point of contact for more information about Oracle Clinical One Analytics training and mentoring.

With the new Audit Trail dashboard, the auditing process has become more efficient. You can now pick between several reports, each addressing a particular scenario, which makes it easier to obtain precise data for a specific part of the auditing process. To further improve the efficiency of your work, the visualizations available in each of these reports are specifically selected to best illustrate the data. Some visualizations you can also interact with, giving you the option to dynamically adjust them to better suit your needs.

The Audit Trail dashboard comes pre-packaged with a set of options, which facilitate your auditing process. This means you can save time on creating a dashboard from scratch. Nonetheless, you can still customize the Audit Trail dashboard to better meet your needs. You can find additional information in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade completes.

Before you work with this feature

Note:

Even though this dashboard is intended to assist sponsor users, the Audit Trail dashboard is available to any user with the appropriate permissions.

The Audit Trail dashboard is built by leveraging an existing dataset in Oracle Clinical One Analytics. Because of this, you must have access to the Subject Form Items Dataset before viewing data in a corresponding dashboard.

Access to a dataset is based on the permission assigned in the Oracle Clinical One Platform. To access the Subject Form Items dataset and, consequently, the Audit Trail dashboard, make sure you have the Run the Subject Form Items Dataset permission assigned.

Note:

New permissions have been introduced to manage read-only and authoring access to Oracle Clinical One Analytics. You can find additional information in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade completes.

Details for sponsor users

As a sponsor user, you can have better control of how you view your study's data using the new Audit Trail dashboard. This new dashboard provides insights on data operations that have occurred in Oracle Clinical One Platform, structured around reports including initial data entry, updates to data, or the clearing and verifying of data. You can also track changes in your study's data on a form by form or a subject by subject basis, and adjust the granularity of these reports according to your needs.

Each of the reports features appropriate visualizations for your data. For instance, the volume of data transactions in your study is illustrated using a heat map, while data modifications on a form-by-form basis are represented using a pivot table.

In the new Audit Trail dashboard, you can switch between the following reports:

• Data Operations Summary: provides object-level summaries of all the data operations that have occurred.
• Data Operations Evolution: provides a view of trends in data operations at an item-level over time.
• Data Operations Analysis: provides summary views of data operations, pivoting and grouping them by properties such as Country, Site, Role, Visit, and Form.
• Data Modification Analysis: identifies the countries, sites, users, subjects, forms, and items that are most frequently modified.
• Form data Modifications Analysis: provides form-level visualizations of the volume of data modifications across a trial.
• Subject Audit Trail Data: consists of a listing table that provides all of the subject data operations that occurred in a study.

You can find additional information regarding this and other dashboards in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade completes.