Operational Oversight (OO) provides a set of pre-defined visualizations populated from the data in the Operational Data Repository and is designed for most operational data consumers. Clients can use these visualizations as-is, or they can use them to serve as starting templates for creating customized sheets. They may also create and build a sheet from the ground up.
Operational Oversight (OO), like all Analytics apps, has several common features such as filtering, selection tools, bookmarks, etc. For details on all Analytics functionality, please refer to the Analytics section or the Analytics courses in the Learning Portal.
In this article, you will find information on all the available out-of-the-box Operational Oversight sheets. Use the Table of Contents at the right to navigate to the sheets of interest.
Important: The list of sheets does not include custom sheets specific to your team.
Operational Oversight Home Page
The Home Page displays high-level summary metrics from Operational Data Repository tables.
Tip: Any applied filters (shown in the Selections toolbar) will remain when you move to another sheet. Remove a filter by clicking the 'x' next to the filter in the Selections toolbar.
Studies by Life Cycle
Use the Studies by Life Cycle sheet to see the overall count of studies in each status as well as potential warning messages. Warning messages reflect potential issues within the study data, for example, "Final Protocol is Behind Schedule by # days." Studies are categorized into four statuses, Planning, Active Pre-Enrollment, Active Enrollment, and Completed.
Use the tabs across the top of the table to see study details in each status.
Study Overview
Use the Study Overview sheet to review high-level status and metrics of ODR studies for reporting and presentation purposes.
For some charts, only one protocol can be displayed at once for analysis.
- The top half of the sheet displays status, enrollment, screenings, and metrics for sites and subjects.
- The lower half presents milestone plans and progress for the overall study and individual sites.
Enrollment Summary
Use the Enrollment Summary sheet to view enrollment metrics by Protocol ID, Country, and Site.
Enrollment Trend
Use the Enrollment Trend sheet to view planned / actual enrollment and cumulative enrollment trends by site and country.
Protocol Deviations
Use the Protocol Deviations sheet to view high-level data relevant to subjects who had protocol deviations.
- On the left of the sheet, enter the threshold (Sites with Rate >=n).
- In the Protocol Deviations Over Time visualization, use the drop-down on the y-axis to view by # of PDs or PD Rate.
- Use the drop-down on the x-axis to view by Date Began or Date Recorded.
- In the Category and Protocol Deviations by Site visualization, use the drop-down arrows on the y-axis to change the view. Options are Category and Site or Protocol Deviation, or Site and Protocol Deviation or Category.
Recruitment and Retention
Use the Recruitment and Retention sheet to monitor enrollment metrics according to user-defined thresholds for key metrics. This helps determine whether a site is enrolling participants at an optimal rate. The report displays values categorized as on target, under target, or in need of action, based on the user-set thresholds. Enrollment target thresholds identify studies falling short of enrollment goals, while screen failure thresholds flag sites experiencing a high percentage of screen failures.
- Enter target thresholds to highlight problem areas with recruitment: Planned Enrollment Target % (>=), and Action Required threshold % (<=).
- Enter target thresholds to highlight problem areas with retention: Discontinued on Target % (<=), and Action Required Threshold % (>=).
Site Monitoring
Use the Site Monitoring sheet to highlight site-related metrics to support site monitoring activities.
If multiple studies are available, select one Protocol ID.
KPI Summary
Use the KPI Summary sheet to review the actuals vs. targets for the following study performance indicators: First Site Active date, Investigator Sites, Active Sites, Non-Performing Sites, Screened Count, Screen Failures, Failure Rate, Protocol Deviations, Enrolled Count, Enrollment Rate, Completed Count, and Discontinued Count.
If multiple studies are available, select one Protocol ID.
Study Progression Metrics
Use the Study Progression Metrics sheet to view key summary information and metrics across ODR studies.
Protocol Milestone Calendar
Use the Protocol Milestone Calendar sheet to view protocol-related milestones in calendar form.
If multiple studies are available, select one Protocol ID.
Site Milestone Calendar
Use the Site Milestone Calendar sheet to view all site-related milestones along with the planned and critical date of each milestone.
If multiple studies are available, select one Protocol ID and one Site.
Clinical Development Plan
Use the Clinical Development Plan sheet to monitor clinical development plan milestone progress across multiple criteria.
Application Information
Use the Application Information sheet to view application information, such as what's new in Operational Oversight for the version you are using, when the data was last refreshed broken out by domain, a glossary of terms used in Operational Oversight, and descriptions of sheets.