Operational Oversight (OO) provides a set of pre-defined sheets that contain visualizations populated with data from the Operational Data Repository. The sheets support operational reporting by presenting study, site, enrollment, milestone, and performance metrics.

This article describes each available out-of-the-box sheet and its purpose. Use the Table of Contents to navigate to the sheet of interest.

Important: The list of sheets does not include custom sheets specific to your organization.

Operational Oversight Home Page

The Home Page displays high-level summary metrics from Operational Data Repository tables.

Tip: Applied filters (shown in the Selections toolbar) remain in effect when navigating to another sheet. To remove a filter, click 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 release highlights, data refresh information by domain, a glossary of Operational Oversight terms, and descriptions of the available sheets.