Oracle® Health Sciences ClearTrial Cloud Service Track User Guide Release 5.2 E51825-01 |
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This chapter provides help descriptions for fields throughout the ClearTrial Track module.
Table 3-1 Costs Tab Fields
Field | Description | Notes |
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Service Provider |
Service provider who is completing work on the study. |
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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 |
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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. |
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Total |
Total amount of planned and actual payments made for the duration of a study. |
Table 3-2 Labor Fees Tab Fields
Field | Description | Notes |
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Service Provider |
Service provider who is completing work on the study. |
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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. |
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Earned Value |
Earned value for the selected service provider in the associated location. |
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Actual |
Labor fees for the selected service provider in the associated location. |
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Columns |
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Major Task |
Major tasks included in a study |
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Month |
Month in which you are tracking labor fees for a major task. |
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Total |
Total amount of planned, earned value, and actual payments for the duration of the study. |
Table 3-3 Milestone Dates Tab Fields
Field | Description | Notes |
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Milestone |
Milestones derived from the baseline plan that is being tracked. |
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Expected |
Expected dates derived from the baseline plan that is being tracked. |
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Actual |
Actual date the study milestone began. |
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Variance (days) |
Difference between the expected milestone dates and the actual milestone dates. |
Table 3-4 Milestone Payments Tab Fields
Field | Description | Notes |
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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 |
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Milestone |
Milestones derived from the baseline plan that is being tracked. |
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Planned Date |
Planned dates derived from the baseline plan that is being tracked. |
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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. |
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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. |
Table 3-5 Monitoring Tab fields
Field | Description | Notes |
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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. |
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Columns |
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Week Of |
Week in which you can track completed CRFs for a study. |
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Planned To Date |
Number of planned completed CRFs, or EDC equivalent, from the baseline plan. |
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Planned CRF Pages This Week |
Number of planned completed CRFs, or EDC equivalent, for the indicated week from the baseline plan |
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Completed CRF Pages This Week |
Number of completed CRFs, or EDC equivalent, for the indicated week. |
Table 3-6 Report Descriptions
Field | Description | Notes |
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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. |
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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. |
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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. |
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Milestone Dates |
Project milestone dates from Project Activity Start Date to Final Report. This report shows both the planned and actual values. |
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Study Performance Trend Report |
Earned Values (EV), Planned Values (PV), and Actual Payments (AP) over time. |
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Milestone Payment Schedule |
Printable view of the detailed milestone payment history. |
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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. |
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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. |
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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. |
Table 3-7 Settings Tab Fields
Field | Description | Notes |
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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 |
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Major Tasks |
Major tasks included in a study. |
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Track |
Level at which major tasks are tracked. |
You can select Not Tracked for major tasks that are not included in the study. |
Costs |
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Miscellaneous Cost |
Miscellaneous and pass-through costs that are included in a study. |
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Track |
Level at which costs are tracked. |
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Earned Value Options |
Earned value tracking option. |
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Payments |
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Service Provider |
Service providers for which you are tracking payments made for work completed on the study. |
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Payment scheduled |
Interval at which payments are made to service providers. |
Table 3-8 Sites Tab Fields
Field | Description | Notes |
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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. |
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Columns |
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Week Of |
Week in which you can track approved sites for a study. |
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Planned To Date |
Number of planned sites approved from the baseline plan. |
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Planned Sites This Week |
Number of sites approved for the week from the baseline plan. |
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Approved Sites This Week |
Number of sites approved for the week. |
Table 3-9 Studies Screen Fields
Field | Description | Notes |
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Filter |
Search through the studies included on the Studies screen. |
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Modify |
Modify the filter for the Studies screen. |
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New |
Create a new study. |
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Edit |
Edit a study. |
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View |
View study details. |
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Delete |
Delete studies. |
Deleted studies can be restored before they are purged from the application. |
Restore |
Restore deleted studies. |
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Create Plan |
Create a new plan for a study. |
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Track |
Track studies. |
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Columns |
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Study Name |
Available studies in the application. |
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Product/Compound |
Product or compound being studied. |
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Phase |
Study phase. |
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Therapeutic Area |
Therapeutic area targeted for the study. |
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Indication |
Indication targeted for the study. |
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Status |
Study status. |
Table 3-10 Subjects Tab Fields
Field | Description | Notes |
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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. |
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Columns |
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Week Of |
Week in which you can track enrolled subjects for a study. |
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Planned To Date |
Number of planned enrolled subjects from the baseline plan. |
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Planned Subjects This Week |
Number of enrolled subjects for the indicated week from the Baseline plan. |
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Enrolled Subjects This Week |
Number of enrolled subjects for the week. |
Table 3-11 Summary Tab Fields
Field | Description | Notes |
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Providers |
Service providers included in the study summary. |
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View As Of: |
Date through which you want to view study data. |
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Study Status Date |
Date the application uses as the cut off for EVA calculations. |
The provided date is from the Settings tab. |
Project Health |
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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 |
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Planned Value (PV) |
Budgeted cost for the work scheduled to be completed on an activity or work breakdown structure component. |
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Earned Value (EV) |
Budgeted amount for the work actually completed on the schedule activity or work breakdown structure component. |
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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. |
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% Complete |
Percent complete equals the Earned Value to date divided by total project budget, or BAC. |
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Projected at Completion |
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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. |
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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. |
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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). |
Table 3-12 Task Dates Tab Fields
Field | Description | Notes |
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Service Provider |
Service provider who is completing work for major tasks in a study. |
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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. |
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Completed |
Date one which activity related to the major task is completed. |
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Columns |
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Major Task |
Major tasks included in a study. |
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Planned |
Planned values derived from the baseline plan that is being tracked. |
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Actual |
Actual dates for when work was started and completed on a major task. |
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Variance (days) |
Difference between planned and actual values for both the started and completed dates. |
Table 3-13 Task Units Tab Fields
Field | Description | Notes |
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Service Provider |
Service provider who is completing work for major tasks in a study. |
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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 |
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Major Task |
Major tasks included in a study |
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Unit |
Unit of work used to measure a major task's progress. |
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Month |
Month in which you are tracking work completed for a major task. |