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Oracle® Health Sciences ClearTrial Cloud Service Track User Guide
Release 5.1
E36709-02
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2 Tracking Studies

Tracking a Study

After you set the baseline plan and you are ready to enter actuals, the tracked study must be accessed from the Study List Screen.

  1. Navigate to the Study List Screen.

  2. Select the tracked study and click the Track button. From the drop down menu, select Enter Actuals to view the study tabs and to enter actuals.

Viewing a Tracked Study Summary

After a plan has been set as the baseline and actuals have been entered, you can view a summary of the study's project health from the Study List Screen.

To view a tracked study's project health:

  1. Navigate to the Study List Screen.

  2. Select the graph icon next to the tracked study to open the Summary Tab. From here, you can view the project health, study performance trend graph, and projected at completion conditions. See the Summary Tab for more information.

Study Performance Summary Report

The Study Performance Summary Report, available from the Reports Menu, allows you to see the project health of all your tracked studies.

To generate the Study Performance Summary Report:

  1. Navigate to the Study List Screen.

  2. Select “Study Performance Summary Report” from the Reports Menu. Select the information you need included in the report. Click Ok to view the report.

Entering Actuals

Before you begin entering and tracking actuals, you should be familiar with the tabs in the Oracle Health Sciences ClearTrial Track Cloud Service module and the notes function.

Similar to entering assumptions for plans in the Oracle Health Sciences ClearTrial Plan and Source Cloud Service module, there are tabs to enter information for studies that are being tracked.

  • Settings: The Settings Tab is used to configure how actuals will be entered for a study. The Tracking Interval and Study Status Date can be set, as well as the tracking level for major tasks, costs, and payments.

  • Sites: Enter the number of sites approved for each location, for each week, in your study. ClearTrial uses these values for the completed units of work for the Sites Approved Major Task.

  • Subjects: Enter the number of enrolled, randomized subjects for each location, for each week in your study. These values for the completed units of work are used for the Subject/Volunteer Randomized Major Task.

  • Monitoring: Record the number of monitored, cleaned CRF pages (or EDC equivalent) collected for each week of a study. These values are used for units of work for the Monitored, Clean CRF Page Major Task.

  • Task Units: Enter the amount of work completed for each major task, for each service provider, at each location in a study.

  • Task Dates: Enter the actual start and end dates for each major task, for each service provider, at each location in a study.

  • Milestone Dates: Enter the actual dates on which study-level milestones will occur.

  • Milestone Payment: Enter the actual payments made against the milestone payment schedule for each service provider in the study.

  • Labor Fees: Enter the fees, or Actual Cost accrued for each major task, for each service provider, at each location in a study.

  • Costs: Enter the actual costs acquired against the Miscellaneous Costs in your plan, for each service provider at every location in the study for Pass-Through Costs.

  • Summary: This tab provides a project dashboard of your study's progress, with four portlets: Project Health, Study Performance Trend, Current Status, and Projected At Completion.

  • Reports: This tab provides links to Track reports. Each report can be viewed in a separate window, printed, exported to Microsoft Excel, or converted to Adobe Portable Document Format (PDF).

Entering Notes

To help communicate further clarification related to your tracked actuals to other users, you can use the ClearTrial notes function. To record notes while entering actuals, click the Notes button in the upper right corner of each tab.

Notes can be public or private. Public notes can be included on reports that are generated from the Reports Tab. Private notes are only visible to users who are entering actual data for the tracked study.