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Oracle® Health Sciences ClearTrial Cloud Service Track User Guide Release 4.8 E36709-01 |
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# 1 Baseline Plans

Plans created in the Oracle Health Sciences ClearTrial Plan and Source Cloud Service module can be tracked in the Oracle Health Sciences ClearTrial Track Cloud Service module, after they have been set as the baseline plan. The Track module allows you enter actuals against a study.

## 1.1 Identifying the Baseline Plan

Before a plan can be tracked, it should be set as the baseline plan and adjusted to reflect the final negotiated contract in the Oracle Health Sciences ClearTrial Plan and Source Cloud Service module. The baseline plan should be the plan that has been approved as the operational plan for the study and contains the final agreed-upon assumptions of the study.

After a plan has been set as the baseline, it is locked and cannot be modified. However, if changes need to be made while the study is being tracked, the baseline plan can be unlocked from the Plan List Screen. Any changes made will be reflected in the tracked study.

If a plan is reforecasted and set as the baseline plan, it will be locked and cannot be unlocked. Reforecasted baseline plans cannot be modified. For more information about reforecasting and how to set a reforecasted plan as a baseline, see Reforecasting.

### 1.1.1 Baseline Plan

A plan selected as the baseline plan is the operational plan for the study against which you will track actual progress, costs, accruals, and earned value.

A study can only be tracked once. If multiple plans are associated with the study, only one may be selected as the baseline to track against. Once a plan is set as the baseline, you will be able to modify all plan assumptions except for the plan status and the modeling currency.

### 1.1.2 Adjusting the Baseline Plan to Reflect the Negotiated Contract

If any portion of your study is outsourced to a service provider, you may need to adjust the unit costs, unit hours, resource billing rates, etc. in the plan to reflect the final negotiated contract values. This ensures you are tracking against the budget and plan that is in the final negotiated contract. All adjustments can be made in Oracle Health Sciences ClearTrial Plan and Source Cloud Service module.

Note: If you need information on creating and editing plans for a study, refer the Oracle Health Sciences ClearTrial Plan and Source Cloud Service User Guide.

To adjust a plan:

1. Login to the application.

2. From the Plan List Screen, choose a plan that is going to be set as the baseline plan and click the Edit button.

3. Adjust the major tasks' number of units, unit hours, and unit costs to reflect the final contracted value:

   1. Click the Labor Tab and select a major task

   2. Click the Adjust Hours or Fees button to open the Major Task Adjustments Tab in ClearTrial Task Manager. Use the Adjustments Tab to edit the number of units, unit hours, and unit costs for the selected major task.

   3. Navigate to the Major Task Distribution Tab and edit the distribution method for the Service Provider completing work on the assigned major task.

   4. Click Save.

      Note: It is recommended that after adjustments are made to the number of units, unit hours, and unit costs, you bulk pin labor for all the major tasks in the plan. This can be done by clicking the "Pin Labor" link at the top of the major task list. Labor should be pinned in case if adjustments need to be made to the baseline plan. Bulk pinning major task adjustments for major tasks in a plan ensures the values will be protected from inheriting edits made in the plan. Pinning guarantees the adjusted values remain aligned with the study contract, bid, or internal tasks.

4. After all of the major tasks for a plan have been adjusted, ensure the plan costs are correct. To adjust a cost to reflect the final contracted value:

   1. Navigate to the Costs Tab. Select the cost from the list and click the Edit Cost button to open the Edit or Adjust Dialog. Use the Cost Algorithm Tab to adjust how costs will be calculated in each location.

   2. Click the Distribution Tab and make adjustments to the cost distribution as needed.

   3. Click Save.

5. Once the plan has been adjusted and saved, it can be set as the baseline plan.

## 1.2 Setting the Baseline Plan

There are two methods for setting the baseline plan, from either the Study List Screen or the Plan List Screen.

To set the Baseline Plan from the Study List Screen:

1. Login to the application.

2. Select Studies from the Edit menu to display the Study List Screen.

3. Select a study that has a plan you need to set as the baseline. Click the Track... button and select Enter Actuals.

   If the study has multiple plans, you are prompted to select the designated baseline plan from a list of available plans. The Edit Actuals screen is displayed and you can begin entering actuals.

   The baseline plan becomes locked and cannot be modified unless if it is unlocked from the Plan List Screen. Any modifications made to the baseline plan will be reflected in the tracked study.

4. Enter your actuals and click save when finished.

To set the Baseline Plan from the Plan List Screen:

1. Login to the application.

2. From the Plan List Screen, select the plan to be tracked. Click the Other Actions... button and select Set as Baseline. This plan is the baseline and any subsequent tracking of actual progress and costs are performed against this plan.

   The baseline plan becomes locked and cannot be modified unless if it is unlocked from the Plan List Screen. Any modifications made to the baseline plan will be reflected in the tracked study.

3. To start entering actual study progress data, navigate to the Study List Screen and select your study. Click the Track... button and select Enter Actuals to begin tracking. Click save when finished.

### 1.2.1 Editing a Baseline Plan

Once a plan is set as the baseline, it is locked. However, it can be unlocked from the Plan List Screen and you can modify all of the plan assumptions except for the plan status and the modeling currency.

To edit a baselined plan, select it from the Plan List Screen and click the the Other Actions... button to unlock it. Click the Edit button to begin modifying assumptions.

If the baseline plan is a reforecasted plan that was set as the baseline, it cannot be modified. For more information about reforecasting and how to set a reforecasted plan as a baseline, see Reforecasting.

## 1.3 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.

To open a tracked study:

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.

### 1.3.1 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.

### 1.3.2 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.