2 Tracking Studies

This chapter provides information on tracking studies.

Select Track Settings for a Study: Settings Tab

The options on the Settings tab determine how you enter tracking data on the Edit Actuals screen.

Opening the Settings Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Settings tab.

The Settings tab appears.

For more information about the fields on this screen, see Settings Tab Fields.

Selecting a Tracking Interval

You can select either the monthly or weekly interval to track a study. This setting determines whether you can enter actuals weekly or monthly on the rest of the tabs on the Edit Actuals screen.

In the Track this study field, select Monthly or Weekly.
Click Save.

Entering a Study Status Date

The Study Status Date is the date through which progress reporting is complete. The application uses this date as the cutoff date for EVA calculations. Update this field as the study progress and actuals are entered.

In the Study Status Date field, enter the date or click the calendar icon to select a date.
Click Save.

Selecting a Tracking Level for Major Tasks and Miscellaneous Costs

Click the Major Tasks tab or the Costs tab.
Select a tracking level for each major task or miscellaneous cost. The application applies this setting to the rest of the tabs on the Edit Actuals screen.
- Study Level—Track the major task or cost on a study-wide basis.
- Location Level—Track the major task or cost on a per-location basis. You can enter actuals for each location in the study.
- Not Tracked—Do not enter actuals for a major task or cost.
Click Save.

Selecting Earned Value Options for Miscellaneous Costs

Click the Costs tab.

A list of miscellaneous costs appears.
In the Earned Value Options column, select an earned value option for each miscellaneous cost.
- Enter AP Only (sets AP to EV)—Enter the values that have been paid. The application sets the earned value to be equal to what is entered for the actual payment.
- Enter EV and AP—Track separately what is reported as earned based on completed work and what is actually paid.
- Derived—The application selects this option by default for certain costs that are driven from completed work. You can only select derived for costs that are defined with a task-based cost driver.
Click Save.

Selecting How Payments are Tracked for each Service Provider

Click the Payments tab.

A list of service providers in the study appears.
In the payment tracking options column, select a payment option for each service provider.
- Study Level—Track the major task or cost on a study-wide basis.
- Location Level: Track the major task or cost on a per-location basis. You can enter actuals for each location in the study.
- Pay for work completed upon milestone achieved—Track actual costs according to the Milestone Payment schedule in the baseline plan and pay for work completed based on milestones achieved. This option is not available for tracking the sponsor's internal costs.
- Pay fixed fee upon milestone achieved—Track actual costs according to the Milestone Payment schedule in the baseline plan and pay a fixed fee based on milestones achieved.
- Enter AP Only (Sets AP to EV)—Select this option if you do not need detailed cost tracking. If you select this option, the application sets the service provider's payments to their completed work.
Click Save.

Enter Approved Sites: Sites tab

On the Sites tab, you enter the number of sites approved for each location, for each week, in the study. The application uses these values for the completed units of work for the sites approved major task.

If you opted to track enrollment on a Study Level basis on the Settings tab, you do not have the option to enter enrolled subjects on a Location Level basis.

The values in the Planned to Date and Planned Sites This Week columns are supplied by the baseline plan you selected to track.

Opening the Sites Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Sites tab.

The Sites tab opens, allowing you to enter the number of approved sites for each location in the study.

For more information about the fields on this screen, see Sites Tab Fields.

Enter Approved Sites for each Week

From the Location drop-down list, select a location.
For each week in the study, in the Approved Sites This Week field, enter the number of sites approved.
Click Save.

Adding a Later Week

From the Location drop-down list, select a location.
Click Add Later Week.

The application adds another week to the bottom of the weeks list.
Click Save.

Enter Enrolled Study Subjects: Subjects Tab

On the Subjects tab, you enter the number of enrolled, randomized subjects for each location, for each week, in the study. The application uses these values for the completed units of work for the subject/volunteer randomized major task.

If you opted to track enrollment on a Study Level basis on the Settings tab, you do not have the option to enter enrolled subjects on a Location Level basis.

The values in the Planned to Date and Planned Subjects This Week columns are supplied by the baseline plan you selected to track.

Opening the Subjects Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Subjects tab.

The Subjects tab appears, allowing you to enter the number of enrolled subjects per week.

For more information about the fields on this screen, see Subjects Tab Fields.

Entering Enrolled Subjects for Each Week

From the Location drop-down list, select a location.
For each week, enter the number of enrolled subjects.
Click Save.

Adding Earlier and Later Weeks

From the Location drop-down list, select a location.
Click Add Earlier Week or Add Later Week.
- By default, the last week shown is the week of the Last Subject/Patient In (LSI/LPI) milestone. To capture subjects that were enrolled after the planned LSI/LPI, click Add Later Week.
- The first week shown is the week of the First Subject/Patient In (FSI/FPI) milestone. To capture subjects that were enrolled before the planned FSI/FPI click Add Earlier Week.
Click Save.

The application adds another week to the list.

Enter Completed Case Report Forms: Monitoring Tab

On the Monitoring tab, you enter the number of Case Report Form (CRF) pages, or Electronic Data Capture (EDC) equivalent, collected for each week in the study. The application uses these values for the completed units of work for the Monitored, Clean CRF Page major tasks.

If you opted to track monitoring on a Study Level basis on the Settings tab, you do not have the option to enter completed CRF pages on a Location Level basis.

The values in the Planned to Date and Planned CRF Pages This Week columns are supplied by the baseline plan you selected to track.

Opening the Monitoring Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Monitoring tab.

The Monitoring tab appears, allowing you to enter the number of completed CRF pages per week.

For more information about the fields on this screen, see Monitoring Tab Fields.

Entering the Number of Completed CRF Pages

From the Locations drop-down list, select a location.
For each week in the study, in the Completed CRF Pages This Week column, enter the number of completed CRF pages.
Click Save.

Adding Earlier and Later Weeks

From the Locations drop-down list, select a location.
Click Add Earlier Week or Add Later Week.
- By default, the last week shown is the week of the Last Subject/Patient In (LSI/LPI) milestone. To capture subjects that were enrolled after the planned LSI/LPI, click Add Later Week.
- The first week shown is the week of the First Subject/Patient In (FSI/FPI) milestone. To capture subjects that were enrolled before the planned FSI/FPI click Add Earlier Week.
Click Save.

The application adds another week to the list.

Track Work Completed by Service Providers: Task Units Tab

On the Task Units tab, you enter the amount of work completed for each major task, for each service provider, at each location in the study. Major tasks are groups of tasks, or labor, that is being completed for the study.

The values in the planned fields for each major task are supplied by the baseline plan you selected to track.

Opening the Task Units Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Task Units tab.

The Task Units tab opens, allowing you to enter the amount of work completed for each major task.

For more information about the fields on this screen, see Task Units tab Fields.

Entering Completed Work for Major Tasks

From the Service Provider drop-down list, select a service provider.

Major tasks assigned to the service provider appear.
From the Locations drop-down list, select a location.
For each major task, in the Actual field, enter the amount of work completed.
Click Save.

Track Dates for Work Completed by Service Providers: Task Dates Tab

On the Task Dates tab, you enter the start and end dates associated with each major task, for each service provider, at each location in your study.

Task dates are the start and end dates for when work was completed for a major task. Major tasks are groups of tasks, or labor, that is being completed for the study.

The started and completed dates in the Planned column are supplied by the baseline plan you selected to track.

The Variance (days) column displays the number of days that lapsed between the date you planned and the actual date.

Opening the Task Dates Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Task Dates tab.

The Task Dates tab appears, allowing you to enter the start and end dates associated with each major task.

For more information about the fields on this screen, see Task Dates Tab Fields.

Entering the Start and Completed Dates

From the Service Provider drop-down list, select a service provider.

Major tasks assigned to the service provider appear.
From the Locations drop-down list, select a location.
For each major task, in the Actual column, enter the date or click the calendar icon to select a date.
Click Save.

Track Dates for Study Milestones: Milestone Dates Tab

On the Milestone Dates tab, you enter the start dates for study milestones. Study milestones are major events that take place during a study. Milestones are populated by the baseline plan you selected to track.

The Variance (days) column displays the number of days that lapsed between the expected date and the actual date.

Opening the Milestone Dates Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Milestone Dates tab.

The Milestone Dates tab appears, allowing you to enter milestone start dates.

For more information about the fields on this screen, see Milestone Dates Tab Fields.

Entering Dates Study Milestones Occur

For each milestone, in the Actual column, enter the date or click the calendar icon to select a date.
Click Save.

Track Payments Made Against the Milestone Payment Schedule: Milestone Payments Tab

On the Milestone Payments tab, you can enter the actual payments made against the milestone payment schedule for each service provider. Values displayed only include items you have chosen to track.

Milestone payments are made at a study milestone. All monetary values are displayed in US dollars.

Opening the Milestone Payments Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Milestone Payments tab.

The Milestone Payments tab appears, allowing you to enter milestone start dates.

For more information about the fields on this screen, see Milestone Dates Tab Fields.

Entering Actual Payments

From the Service Provider drop-down list, select a service provider.

Study milestones associated with the service provider appear.
For each milestone, in the Actual Payment column, enter the amount paid.
Click Save.

Track Labor for Service Providers: Labor Fees Tab

On the Labor Fees tab, you enter the fees accrued for each major task, for each service provider, at each location in the study.

The application provides the ability for you to capture unplanned costs. You can enter data for all service providers and locations in the study, regardless of whether planned fees exist for each combination. Oracle recommends that if you accumulate significant unplanned costs, you reforecast the baseline plan to ensure the earned value calculations are accurate. For more information about reforecasting, see Reforecasting Baseline Plans.

If your payment schedule indicates that a payment occurs later than the predicted study end date, the application moves that payment date to the study end date. Enter your actual payment on this date.

Opening the Labor Fees Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Labor Fees tab.

A list of major tasks appears, allowing you to enter labor fees.

For more information about the fields on this screen, see Labor Fees Tab Fields.

Entering Actual Fees for Major Tasks

From the Service Provider drop-down list, select a service provider.

A list of major tasks associated with the service provider appears.
From the Locations drop-down list, select a location.
For each major task, in the Actual field, enter the labor fees.
Click Save.

Track Costs for Each Service Provider: Costs Tab

On the Costs tab, you enter costs accrued against the miscellaneous and pass-through costs in your study for each service provider, at each location in your study.

The application provides the ability for you to capture unplanned costs. You can enter data for all service providers and locations in the study, regardless of whether miscellaneous costs apply to each combination. Oracle recommends that if you accumulate significant unplanned costs, you reforecast the baseline plan to ensure the earned value calculations are accurate. For more information about reforecasting, see Reforecasting Baseline Plans.

The values in the planned fields are supplied by the baseline plan you selected to track.

Opening the Costs Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Costs tab.

A list of costs appears, allowing you to enter labor fees.

For more information about the fields on this screen, see Costs Tab Fields.

Entering the Actual/Earned Value for Costs

From the Service Provider drop-down list, select a service provider.

A list of costs associated with the service provider appears.
From the Locations drop-down list, select a location.
For each miscellaneous and pass-through cost, in the Actual/Earned Value field, enter the costs accrued.
Click Save.

Evaluate your Study's Progress: Summary Tab

On the Summary tab, you evaluate your study's progress by selecting various service providers and data to include in the summary.

Opening the Summary Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
Click Track and select Enter Actuals.

The Edit Actuals screen appears.
Click the Summary tab.

A summary of your study's progress appears.

For more information about the fields on this screen, see Summary Tab Fields.

Select Data to Include in the Study Summary

The Summary tab allows you to select the data and service providers that appear in the summary.

Including and Excluding Data

In the Summary Project Status & Earned Value Analysis (EVA) section, check the checkbox of the data you want to include in the summary and uncheck the checkbox of the data to exclude.
Click Save.

Selecting Providers to Include in the Study Summary

From the Providers drop-down list, select a service provider.

The application calculates the summary data based on the service provider you selected.
Click Save.

Selecting a View As Of date to Include in the Study Summary

In the View As Of field, enter the date or click the calendar icon to select a date.

The application calculates the summary data based on the date you selected. You can click Reset to change the date back to the Study Status Date.
Click Save.

View Project Performance with the Project Health Data

The Project Health data provides an overview of the project performance for the labor fees and costs in your study. The cells containing these values are colored to indicate project health:

Green—A healthy project. No changes need to be made and the project is proceeding according to plan.
Yellow—A warning that the project is starting to deviate from the plan. The project's performance should be evaluated in detail.
Red—A warning that the project has significantly deviated from the plan. Operational changes are needed to bring the project back in alignment with the plan.
No color—The study is exceeding expectations and data should be reviewed to ensure there are no errors.

View the Study Performance Trend Graph

The Study Performance Trend Graph, in the Study Performance data, shows the Actual Payments, Earned Value, and Planned Value across the entire timeline and costs of the study.

To see the value at any point on one of the lines, place your mouse over the line. To zoom in to a section of the graph, click and drag your mouse over a desired section. To return to the all-study view, double click within the graph.

Viewing Project Performance Details

In the Project Health, Current Status, and Projected At Completion data, you can generate a report that provides a more detailed view of the project health.

In the Project Health, Current Status, or Projected At Completion data, click the Detail link.

The Tracking Detail Report appears.
Enter details you want to include in the report.
Click Ok.

Generate Tracking Reports: Reports Tab

On the Reports tab, you can generate detailed reports that provide valuable information related to study progress and overall health.

Opening the Reports Tab

From the Edit menu, select Studies.

The Studies screen appears.
Select the checkbox of the study.
From the Track menu, select Enter Actuals.

The Edit Actuals screen appears.
Click the Reports tab.

A list of available reports appears.

For more information about the reports on this screen, see Report Descriptions.

Generating a Report

Click a report link.

If applicable, a dialog box appears.
Enter details you want to include in the report.
Click Ok.