Create custom reports and dashboards using Oracle Life Sciences Clinical One Analytics

Sponsor users can now create custom reports and dashboards to better visualize and analyze data from Oracle Clinical One Platform using Oracle Clinical One Analytics.

What are the benefits?

Thanks to Oracle Clinical One Analytics, you can now create more robust and customized reports using your operational and clinical study data. Moreover, you can also create your own data dashboards that let you visualize study data in a smart and easy way. This new feature lets you:

• Create custom tabular reports where you can view the data that is relevant to your task
• Visualize study analytics through customized dashboards to make data-driven decisions
• Perform cross-study reporting and data analysis
• Export data in a CSV or PDF format

Details for user administrators

There are six new permissions that a user administrator can assign to a user who should access Oracle Clinical One Analytics. A sponsor user cannot work in the Oracle Clinical One Analytics environment without at least one of the required permissions. Each type of dataset has a corresponding permission.

• Run the Blinded Subject Events Dataset
• Run the Subject Dataset
• Run the Subject Form Items Dataset
• Run the Subject Forms Dataset
• Run the Unblinded Subject Events Dataset
• Run the Queries Dataset

Details for study team members

When it comes to custom reports and dashboards, you can create them by clicking the new Analytics tab. This will take you to the Oracle Clinical One Analytics environment where you can access your datasets and use them to export data, and create visualizations or dashboards. The Analytics tab is available for studies in Testing, Training, and Production mode in Oracle Clinical One Platform.

Datasets represent a consolidated view of study information that allows a non-technical user to combine many different levels of data in a useful and visual way.

For more details on how you can visualize data in Oracle Clinical One Analytics, see Get Started with Visualizing Data.

Here is a list of all the predefined datasets that you can use to generate custom reports and dashboards:

Type of custom report	Examples of data that can be viewed
Subject Dataset	This dataset will make subject-related data easier to view and analyze, allowing you to make better data-driven decisions. For example, you can: Create a dashboard that displays the number of active subjects per site in your study. View trends in enrollment and dropout in your study over time.
Unblinded Subject Events Dataset	This dataset offers you all data available in the Blinded Subject Events Dataset plus additional unblinded information about kits and treatment arms. For example, you can: Create a visit status report for all subjects within a certain treatment arm. View trends in dosage for subjects over the course of their visits.
Blinded Subject Events Dataset	This dataset allows you to view the events and visits data collected throughout your study. For example, you can: View subjects who have completed a screening visit in a certain country. Create a report of all events that occurred at a site during a certain month. Create a dashboard that displays visit status per subject to quickly pinpoint missing visits.
Subject Forms Dataset	This dataset complements the Subject Items Dataset well. If you are only interested in looking at data at the form level, without the need to see individual questions, this report meets your needs. For example, you can: View what forms are available for source data verification at a certain site. View when should you schedule an onsite visit based on the amount of completed forms since their last onsite visit.
Subject Form Items Dataset	This dataset allows you to create reports and dashboards on all subject form items collected in your study. For example, with this dataset you can: View missing items for each form across all subjects in your study. View all form items that have been signed and verified for a subject. Generate reports for subject age, gender, height, weight, and more for a study.
Queries Dataset	This dataset offers you an overview of all queries that have been raised in your study, so you can quickly resolve those queries and ensure you have accurate and clean data from your sites. For example, you can: View all open and answered queries for quick resolution Identify questions with the most queries across your study

Already working in a live study?

As a sponsor user, whether you are working in a brand new or existing study, you can go ahead and start using Oracle Clinical One Analytics after the deployment of this feature is complete and you are assigned the appropriate permissions.

Keep in mind that the deployment of this feature is gradual. Depending on the organization that you work in, you may not see the new Analytics tab right away and you may have to wait some time until you can use the feature. For more questions and detailed guidance on how to use this new feature, contact your Oracle Project Manager.