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Oracle® Health Sciences ClearTrial Cloud Service TRACK User Guide
Release 5.4
E69289-01
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3 Track Screen and Dialog Box Field Descriptions

This chapter provides help descriptions for fields throughout the ClearTrial Track module.

Costs Tab Fields

Table 3-1 Costs Tab Fields

Field Description Notes

Service Provider

Service provider who is completing work on the study.


Location

Location in which you are tracking costs for the selected service provider.

The available locations are derived from the baseline plan being tracked.

Columns



Cost

Assigned costs in a study.

The assigned costs are from the Costs tab of the baseline plan.

Month

Month in which you are tracking costs.


Total

Total amount of planned and actual payments made for the duration of a study.



Labor Fees Tab Fields

Table 3-2 Labor Fees Tab Fields

Field Description Notes

Service Provider

Service provider who is completing work on the study.


Location

Location in which you are tracking labor fees for work completed on major tasks.

The available locations are derived from the baseline plan being tracked.

Planned

Budget for the selected service provider in the associated location, derived from the baseline plan.


Earned Value

Earned value for the selected service provider in the associated location.


Actual

Labor fees for the selected service provider in the associated location.


Columns



Major Task

Major tasks included in a study


Month

Month in which you are tracking labor fees for a major task.


Total

Total amount of planned, earned value, and actual payments for the duration of the study.



Milestone Dates Tab Fields

Table 3-3 Milestone Dates Tab Fields

Field Description Notes

Milestone

Milestones derived from the baseline plan that is being tracked.


Expected

Expected dates derived from the baseline plan that is being tracked.


Actual

Actual date the study milestone began.


Variance (days)

Difference between the expected milestone dates and the actual milestone dates.



Milestone Payments Tab Fields

Table 3-4 Milestone Payments Tab Fields

Field Description Notes

Service Provider

Service provider who is completing work on the study.

You can only enter milestone payments for service providers that were selected to have payments tracked by milestone on the Settings tab.

Columns



Milestone

Milestones derived from the baseline plan that is being tracked.


Planned Date

Planned dates derived from the baseline plan that is being tracked.


Actual Date

Actual date the milestone payment was made.

The displayed date is the date from the Milestone Dates tab.

Scheduled Payment

Planned payment amounts according to the milestone payment schedule in the baseline plan being tracked.


Earned Value to Date

Summation of the earned values entered from the beginning of the study to each milestone.

The application calculates the earned value by applying the ratio of units of work completed to planned units to the planned value.

Actual Payment

Amount paid to the service provider.



Monitoring Tab Fields

Table 3-5 Monitoring Tab fields

Field Description Notes

Location

Location in which you are tracking completed CRF pages.

If you are tracking on a study level basis, this field is unavailable.

Add Earlier Week

Subjects enrolled before the First Subject/Patient In (FSI/FPI) milestone.

By default, the first week shown is the FSI/FPI milestone.

Add Later Week

Subjects enrolled after the Last Subject/Patient Out (LSO/LPO) milestone.

By default, the last week shown is the LSO/LPO milestone.

Total

Number of CRF pages, or EDC equivalent, collected for the designated location, or for all locations, if you are tracking on an all location basis.


Columns



Week Of

Week in which you can track completed CRFs for a study.


Planned To Date

Number of planned completed CRFs, or EDC equivalent, from the baseline plan.


Planned CRF Pages This Week

Number of planned completed CRFs, or EDC equivalent, for the indicated week from the baseline plan


Completed CRF Pages This Week

Number of completed CRFs, or EDC equivalent, for the indicated week.



Report Descriptions

Table 3-6 Report Descriptions

Field Description Notes

Site Approval Schedule

Site approval curve for the entire study over time. It displays both the planned and actual values. This report can be run at the study level or per location.


Subject Enrollment

Subject enrollment curve for the entire study over time. It displays both the planned and actual values. This report can be run at the study level or per-location.


CRF Pages

Distribution of collected CRF pages over time. It displays both the planned and actual values. This report can be run at the study level or per-location.


Milestone Dates

Project milestone dates from Project Activity Start Date to Final Report. This report shows both the planned and actual values.


Study Performance Trend Report

Earned Values (EV), Planned Values (PV), and Actual Payments (AP) over time.


Milestone Payment Schedule

Printable view of the detailed milestone payment history.


Tracking Summary

Printable view of the Project Health, Current Status, Cash Flow Analysis, and Projected At Completion. This report can be run for all service providers or a selected one.


Tracking Detail

Provides a granular view of the project health. Providers and locations can be filtered to be included or excluded. The report can be run with major tasks, miscellaneous costs, or both, and earned value metrics.


Accruals

Provides a view of work performed, actual payments, and the remaining cost accrual for work that has been performed but for which has not been paid. It can be displayed to show a period of time, cumulative for a project to date, for one or more providers and other parameters.



Settings Tab Fields

Table 3-7 Settings Tab Fields

Field Description Notes

Tracking Interval

Interval at which you track actuals for the study.

You can track weekly or monthly.

Study Status Date

Date the application uses as the cut-off for EVA calculations.

You must update this field as actuals are entered.

Major Tasks



Major Tasks

Major tasks included in a study.


Track

Level at which major tasks are tracked.

You can select Not Tracked for major tasks that are not included in the study.

Costs



Miscellaneous Cost

Miscellaneous and pass-through costs that are included in a study.


Track

Level at which costs are tracked.


Earned Value Options

Earned value tracking option.


Payments



Service Provider

Service providers for which you are tracking payments made for work completed on the study.


Payment scheduled

Interval at which payments are made to service providers.



Sites Tab Fields

Table 3-8 Sites Tab Fields

Field Description Notes

Location

Location in which you are tracking approved sites.

If you are tracking on a study level basis, this field is unavailable.

Add Later Week

Site approvals that occur after the last site is approved.

By default, the first week displayed is the week of the Project Activity Start Date and the last week shown is the week of the Last Site Approved milestone.

Total

Total number of Planned Sites and Approved sites for the designated location, or for all locations if you are tracking on an all location basis.


Columns



Week Of

Week in which you can track approved sites for a study.


Planned To Date

Number of planned sites approved from the baseline plan.


Planned Sites This Week

Number of sites approved for the week from the baseline plan.


Approved Sites This Week

Number of sites approved for the week.



Studies Screen Fields

Table 3-9 Studies Screen Fields

Field Description Notes

Filter

Search through the studies included on the Studies screen.


Modify

Modify the filter for the Studies screen.


New

Create a new study.


Edit

Edit a study.


View

View study details.


Delete

Delete studies.

Deleted studies can be restored before they are purged from the application.

Restore

Restore deleted studies.


Create Plan

Create a new plan for a study.


Track

Track studies.


Columns



Study Name

Available studies in the application.


Product/Compound

Product or compound being studied.


Phase

Study phase.


Therapeutic Area

Therapeutic area targeted for the study.


Indication

Indication targeted for the study.


Status

Study status.



Subjects Tab Fields

Table 3-10 Subjects Tab Fields

Field Description Notes

Location

Location in which you are tracking enrolled subjects.

If you are tracking on a study level basis, this field is unavailable.

Add Earlier Week

Subjects enrolled before the First Subject/Patient In (FSI/FPI) milestone.

By default, the first week displayed is the week of the FSI/FPI milestone.

Add Later Week

Subjects enrolled after the Last Subject/Patient In (LSI/LPI) milestone.

By default, the last week displayed is the week of the LSI/LPI milestone.

Total

Number of Planned Subjects and Enrolled Subjects for the designated location, or for all locations if you are tracking on an all location basis.


Columns



Week Of

Week in which you can track enrolled subjects for a study.


Planned To Date

Number of planned enrolled subjects from the baseline plan.


Planned Subjects This Week

Number of enrolled subjects for the indicated week from the Baseline plan.


Enrolled Subjects This Week

Number of enrolled subjects for the week.



Summary Tab Fields

Table 3-11 Summary Tab Fields

Field Description Notes

Providers

Service providers included in the study summary.


View As Of:

Date through which you want to view study data.


Study Status Date

Date the application uses as the cut off for EVA calculations.

The provided date is from the Settings tab.

Project Health



Schedule Performance

Predicts the completion date and is sometimes used in conjunction with the Budget Performance (BP) to forecast the project completion estimates.

An SP value less than 1.0 indicates the project is behind schedule. An SP value greater than 1.0 indicates the project is ahead of schedule.

Budget Performance

A commonly used cost-efficiency indicator.

A BP value less than 1.0 indicates a cost overrun of the estimates.

A BP value greater than 1.0 indicates a cost underrun of the estimates.

Overall Performance

Combines the Schedule Performance (SP) and the Budget Performance (BP) to provide an overall project health indicator.

An Overall Performance (OP) value less than 1.0 indicates composite cost or schedule overruns.

An OP value greater than 1.0 indicates composite cost or schedule underruns.

Current Status



Planned Value (PV)

Budgeted cost for the work scheduled to be completed on an activity or work breakdown structure component.


Earned Value (EV)

Budgeted amount for the work actually completed on the schedule activity or work breakdown structure component.


Actual Payments (AP)

Total costs actually incurred and recorded in accomplishing work performed for a schedule activity or work breakdown structure component.

Actual cost can sometimes be direct labor hours alone, direct costs alone, or all costs including indirect costs.

Cost Variance (CV)

Difference between the budget at completion (BAC) and the actual amount spent.


% Complete

Percent complete equals the Earned Value to date divided by total project budget, or BAC.


Projected at Completion



Estimate to Complete (ETC)

Estimated cost required to complete the remainder of the project given your current actual payments for the project and your current budget performance.

To calculate the ETC, the Budget at Complete (BAC) is divided by the current Budget Performance (BP), and the current Actual Payments (AP) are subtracted.

Budget at Complete (BAC)

Total original planned project budget. The BAC represents the sum of all Planned Values (PV) for the project at completion.


Estimate at Complete (EAC)

Total estimated cost at the end of the project.

To calculate the EAC, the Budget at Complete (BAC) is divided by the current Budget Performance (BP).

Variance at Complete (VAC)

Difference between the original planned project Budget at Complete (BAC) and the Estimate at Complete (EAC), calculated based on your current performance.


Study Completion Date

The Planned Study Completion Date is the Final Report milestone date from the Baseline Plan.

The Estimated Study Completion Date is calculated by using your original planned study duration and applying your current Schedule Performance (SP).



Task Dates Tab Fields

Table 3-12 Task Dates Tab Fields

Field Description Notes

Service Provider

Service provider who is completing work for major tasks in a study.


Location

Location in which you are tracking dates for work completed on major tasks.

The available locations are derived from the baseline plan being tracked.

Started

Date on which activity related to the major task began.


Completed

Date one which activity related to the major task is completed.


Columns



Major Task

Major tasks included in a study.


Planned

Planned values derived from the baseline plan that is being tracked.


Actual

Actual dates for when work was started and completed on a major task.


Variance (days)

Difference between planned and actual values for both the started and completed dates.



Task Units tab Fields

Table 3-13 Task Units Tab Fields

Field Description Notes

Service Provider

Service provider who is completing work for major tasks in a study.


Location

Location in which you are tracking work completed for major tasks.

The available locations are derived from the baseline plan being tracked.

Planned

Planned values derived from the baseline plan that is being tracked.

Major tasks that have a single completed unit of work, the Planned Value displays as a percentage.

For other major tasks, the planned value displays the number of planned units of work.

Actual

Completed units of work for the major task, for the associated service provider in the selected location.

If the major task has a single completed unit of work, you enter the percentage of work that was completed in the time period. Otherwise, enter numeric values to represent the number of units completed in the corresponding time period.

For major tasks that have a single completed unit of work, the percentages you enter are adjusted as you switch from Per-Location to All Location. The application factors in the number of locations when it displays rolled-up percentages.

Columns



Major Task

Major tasks included in a study


Unit

Unit of work used to measure a major task's progress.


Month

Month in which you are tracking work completed for a major task.