Oracle® Health Sciences ClearTrial Cloud Service TRACK User Guide Release 5.5 E71287-01 |
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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 |
---|---|---|
Service Provider |
Service provider who is completing work on the study. |
There are no notes. |
Location |
Location in which you are tracking costs for the selected service provider. |
The available locations are derived from the baseline plan being tracked. |
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. |
There are no notes. |
Total |
Total amount of planned and actual payments made for the duration of a study. |
There are no notes. |
Table 3-2 Labor Fees Tab Fields
Field | Description | Notes |
---|---|---|
Service Provider |
Service provider who is completing work on the study. |
There are no notes. |
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. |
There are no notes. |
Earned Value |
Earned value for the selected service provider in the associated location. |
There are no notes. |
Actual |
Labor fees for the selected service provider in the associated location. |
There are no notes. |
Major Task |
Major tasks included in a study |
There are no notes. |
Month |
Month in which you are tracking labor fees for a major task. |
There are no notes. |
Total |
Total amount of planned, earned value, and actual payments for the duration of the study. |
There are no notes. |
Table 3-3 Milestone Dates Tab Fields
Field | Description | Notes |
---|---|---|
Milestone |
Milestones derived from the baseline plan that is being tracked. |
There are no notes. |
Expected |
Expected dates derived from the baseline plan that is being tracked. |
There are no notes. |
Actual |
Actual date the study milestone began. |
There are no notes. |
Variance (days) |
Difference between the expected milestone dates and the actual milestone dates. |
There are no notes. |
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. |
Milestone |
Milestones derived from the baseline plan that is being tracked. |
There are no notes. |
Planned Date |
Planned dates derived from the baseline plan that is being tracked. |
There are no notes. |
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. |
There are no notes. |
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. |
There are no notes. |
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. |
There are no notes. |
Week Of |
Week in which you can track completed CRFs for a study. |
There are no notes. |
Planned To Date |
Number of planned completed CRFs, or EDC equivalent, from the baseline plan. |
There are no notes. |
Planned CRF Pages This Week |
Number of planned completed CRFs, or EDC equivalent, for the indicated week from the baseline plan |
There are no notes. |
Completed CRF Pages This Week |
Number of completed CRFs, or EDC equivalent, for the indicated week. |
There are no notes. |
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. |
There are no notes. |
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. |
There are no notes. |
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. |
There are no notes. |
Milestone Dates |
Project milestone dates from Project Activity Start Date to Final Report. This report shows both the planned and actual values. |
There are no notes. |
Study Performance Trend Report |
Earned Values (EV), Planned Values (PV), and Actual Payments (AP) over time. |
There are no notes. |
Milestone Payment Schedule |
Printable view of the detailed milestone payment history. |
There are no notes. |
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. |
There are no notes. |
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. |
There are no notes. |
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. |
There are no notes. |
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 included in a study. |
There are no notes. |
Track |
Level at which major tasks are tracked. |
You can select Not Tracked for major tasks that are not included in the study. |
Miscellaneous Cost |
Miscellaneous and pass-through costs that are included in a study. |
There are no notes. |
Track |
Level at which costs are tracked. |
There are no notes. |
Earned Value Options |
Earned value tracking option. |
There are no notes. |
Service Provider |
Service providers for which you are tracking payments made for work completed on the study. |
There are no notes. |
Payment scheduled |
Interval at which payments are made to service providers. |
There are no notes. |
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. |
There are no notes. |
Week Of |
Week in which you can track approved sites for a study. |
There are no notes. |
Planned To Date |
Number of planned sites approved from the baseline plan. |
There are no notes. |
Planned Sites This Week |
Number of sites approved for the week from the baseline plan. |
There are no notes. |
Approved Sites This Week |
Number of sites approved for the week. |
There are no notes. |
Table 3-9 Studies Screen Fields
Field | Description | Notes |
---|---|---|
Filter |
Search through the studies included on the Studies screen. |
There are no notes. |
Modify |
Modify the filter for the Studies screen. |
There are no notes. |
New |
Create a new study. |
There are no notes. |
Edit |
Edit a study. |
There are no notes. |
View |
View study details. |
There are no notes. |
Delete |
Delete studies. |
Deleted studies can be restored before they are purged from the application. |
Restore |
Restore deleted studies. |
There are no notes. |
Create Plan |
Create a new plan for a study. |
There are no notes. |
Track |
Track studies. |
There are no notes. |
Study Name |
Available studies in the application. |
There are no notes. |
Product/Compound |
Product or compound being studied. |
There are no notes. |
Phase |
Study phase. |
There are no notes. |
Therapeutic Area |
Therapeutic area targeted for the study. |
There are no notes. |
Indication |
Indication targeted for the study. |
There are no notes. |
Status |
Study status. |
There are no notes. |
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. |
There are no notes. |
Week Of |
Week in which you can track enrolled subjects for a study. |
There are no notes. |
Planned To Date |
Number of planned enrolled subjects from the baseline plan. |
There are no notes. |
Planned Subjects This Week |
Number of enrolled subjects for the indicated week from the Baseline plan. |
There are no notes. |
Enrolled Subjects This Week |
Number of enrolled subjects for the week. |
There are no notes. |
Table 3-11 Summary Tab Fields
Field | Description | Notes |
---|---|---|
Providers |
Service providers included in the study summary. |
There are no notes. |
View As Of: |
Date through which you want to view study data. |
There are no notes. |
Study Status Date |
Date the application uses as the cut off for EVA calculations. |
The provided date is from the Settings tab. |
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. |
Planned Value (PV) |
Budgeted cost for the work scheduled to be completed on an activity or work breakdown structure component. |
There are no notes. |
Earned Value (EV) |
Budgeted amount for the work actually completed on the schedule activity or work breakdown structure component. |
There are no notes. |
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. |
There are no notes. |
% Complete |
Percent complete equals the Earned Value to date divided by total project budget, or BAC. |
There are no notes. |
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. |
There are no notes. |
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. |
There are no notes. |
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). |
There are no notes. |
Table 3-12 Task Dates Tab Fields
Field | Description | Notes |
---|---|---|
Service Provider |
Service provider who is completing work for major tasks in a study. |
There are no notes. |
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. |
There are no notes. |
Completed |
Date one which activity related to the major task is completed. |
There are no notes. |
Major Task |
Major tasks included in a study. |
There are no notes. |
Planned |
Planned values derived from the baseline plan that is being tracked. |
There are no notes. |
Actual |
Actual dates for when work was started and completed on a major task. |
There are no notes. |
Variance (days) |
Difference between planned and actual values for both the started and completed dates. |
There are no notes. |
Table 3-13 Task Units Tab Fields
Field | Description | Notes |
---|---|---|
Service Provider |
Service provider who is completing work for major tasks in a study. |
There are no notes. |
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. |
Major Task |
Major tasks included in a study |
There are no notes. |
Unit |
Unit of work used to measure a major task's progress. |
There are no notes. |
Month |
Month in which you are tracking work completed for a major task. |
There are no notes. |