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

Use the filters at the top of each sheet to refine the displayed data.

Tip: Applied filters remain when navigating between sheets. Clear a selection from the Selections toolbar to remove the filter.

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.

Studies by Life Cycle

Use the Studies by Life Cycle sheet to review the number of studies in each status and identify potential warning messages. Warning messages indicate potential issues in study data, such as 'Final Protocol is Behind Schedule by # days.' Studies are categorized as Planning, Active Pre-Enrollment, Active Enrollment, or Completed.

Use the tabs across the top of the table to select a status and display the corresponding study details.

Study Overview

Use the Study Overview sheet to review high-level status and metrics for ODR studies.

For some charts, select one protocol from the Protocol ID filter to display data.

• The top half of the sheet displays status, enrollment, screening, and site and subject metrics.
• The lower half displays milestone plans and progress for the overall study and individual sites.

Enrollment Summary

Use the Enrollment Summary sheet to review enrollment metrics by Protocol ID, Country, and Site.

Enrollment Trend

Use the Enrollment Trend sheet to review planned and actual enrollment and cumulative enrollment trends by site and country.

Protocol Deviations

Use the Protocol Deviations sheet to review high-level data for subjects with protocol deviations.

• On the left of the sheet, enter a threshold in Sites with Rate >=n. 
• In the Protocol Deviations Over Time visualization:
  • Use the y-axis drop-down to select # of PDs or PD Rate.
  • Use the x-axis drop-down to select Date Began or Date Recorded.
• In the Category and Protocol Deviations by Site visualization, use the y-axis drop-down arrows to select:
  • Category and Site or Protocol Deviation
  • Site and Protocol Deviation or Category

Recruitment and Retention

Use the Recruitment and Retention sheet to monitor enrollment and retention metrics based on configurable thresholds. Thresholds categorize sites as On Target, Under Target, or Action Required. These categories help identify studies or sites that may require attention.

• Enter recruitment thresholds for Planned Enrollment Target % (>=) and Action Required Threshold % (<=).
• Enter retention thresholds for Discontinued on Target % (<=) and Action Required Threshold % (>=).

Site Monitoring

Use the Site Monitoring sheet to review site-related metrics that support site monitoring activities.

If multiple studies are available, select one protocol from the Protocol ID filter.

KPI Summary

Use the KPI Summary sheet to review actual versus target values 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 from the Protocol ID filter.

For applicable bullet charts, KPI target calculations exclude studies when required Actual or Planned values are missing. Footnotes indicate when incomplete data are excluded from the calculation or when the Actual KPI exceeds the Planned KPI.

Study Progression Metrics

Use the Study Progression Metrics sheet to review key summary information and metrics across ODR studies.

Protocol Milestone Calendar

Use the Protocol Milestone Calendar sheet to review protocol-related milestones in calendar format.

If multiple studies are available, select one protocol from the Protocol ID filter.

Site Milestone Calendar

Use the Site Milestone Calendar sheet to review site-related milestones and their planned and critical dates.

If multiple studies are available, select one protocol from the Protocol ID filter and one site from the Site filter.

Clinical Development Plan

Use the Clinical Development Plan sheet to review clinical development plan milestone progress across multiple criteria.

Application Information

Use the Application Information sheet to view release highlights for the current OO version, data refresh information by domain, a glossary of Operational Oversight terms, and descriptions of available sheets.