1 Getting Started: Basics and Common Tools

This chapter covers the basic functions and tools you can use to manage clinical studies after they are underway.

Using ClearTrial Track to Manage a Study Budget

The ClearTrial Track module is used in conjunction with the ClearTrial Plan and Source module.

You can create plans and set them as baseline plans in Plan and Source, then use Track to manage the study budget. You can access the Track features and capabilities if your organization has a subscription.

The Baseline Plan Supplies the Values to Track

The baseline plan you create in Plan and Source populates the planned values in Track. The baseline plan is your estimate of how much a study is going to cost and how long it is going to take to complete. Tracking the baseline plan after a study is underway provides you with information to assess study progress.

Baseline Plans are Locked

When you set a plan as the baseline, it becomes locked and you can no longer edit it. If changes need to be made while the study is being tracked, the baseline plan can be unlocked from the Plans screen. Any changes made are reflected in the tracked study. For more information, see Locking and Unlocking Baseline Plans.

Planned vs. Actual Values

The planned values the application displays are supplied by the baseline plan you select to track.

The actual values are the values you enter as the study is underway. You can compare actual values with the planned values to assess your study performance.

Enter Actual Values

In the application, you can enter actuals by location or by study level. To avoid data entry errors while tracking by location, ensure you select the correct location before entering data. If you are tracking by study level, you do not have the option to select a location.

A Tabbed Interface Guides You through Tracking a Study

You enter actuals for a tracked study on the Edit Actuals screen. This screen provides access to a set of data entry screens accessed by clicking tabs on the left side of the screen. The tabs appear in a specific order that steps you through a logical approach to entering actuals.

As you complete a tab, you can click Next to go to the next tab. The application highlights the corresponding tab on the left.

Roadmap: Tracking a Study

Table 1-1 Roadmap: Tracking a Study

Step	Action	Description
1	Create a product.	From the Edit menu, select Products. The Products screen appears. Click New. The Create Product screen appears. Enter the product details. For more information about a field, click the field name. Click Save.
2	Create a study.	From the Edit menu, select Studies. The Studies screen appears. Click New. The Create Study screen appears. Enter general information, therapeutic and indication information, and a description or note. For more information about a field, click the field name. Click Save.
3	Create a plan	From the Edit menu, select Plans. The Plans screen appears. Click New. The Choose Study and Plan Template dialog box appears. Select the checkbox of the study for which you are creating a plan. Select a template checkbox. Click Ok. The Create Plan screen appears. Enter the fields as necessary. For more information about a field, click the field name. Click Save. The application adds the plan to the Plans screen.
4	Set the plan as the baseline plan.	The baseline plan is a plan that has been approved as the operational plan for the study and contains the final agreed-upon assumptions. There are two methods for setting the baseline plan. For more information, see Setting the Baseline Plan.
5	Select tracking settings.	The tracking settings must be selected before you can begin entering actuals. Select these settings on the Settings tab of the Edit Actuals screen. For more information, see Select Track Settings for a Study: Settings Tab.
6	Enter actuals on the Edit Actuals screen.
7	Save.

Working with Tracked Studies

This section provides information on how to perform tasks and functions that apply to all tracked studies.

Viewing Tracked Studies on the Studies Screen

1. From the Edit menu, select Studies.

   The Studies screen appears. Tracked studies have a tracking icon in the far right column.

Entering Actuals for a Tracked Study

1. On the Studies screen, select the checkbox of the study for which you want to enter actuals.

2. Click Track and select Enter Actuals.

3. Click Ok.

   The Edit Actuals screen appears.

4. Enter study actuals using the tabs on the left side of the screen. Click Next to proceed to the next tab.

   • For more information about a field, click the field name.

   • For more information about the fields for study actuals, see Chapter 3, "Track Screen and Dialog Box Field Descriptions.".

5. Click Save.

Locking and Unlocking Actuals

You can lock actuals for a tracked study to prevent users from editing data.

1. On the Studies screen, select the checkbox of the study for which you want to lock or unlock actuals.

2. Click Track and select Lock Actuals or Unlock Actuals.

Copying Actuals

1. On the Studies screen, select the checkbox of the study for which you want to copy actuals.

2. Click Track and select Copy Actuals.

   The Copy Actuals dialog box appears.

3. In the Study Name field, enter a study name.

4. In the Plan Name field, enter a plan name.

5. Click Ok.

   The application creates a new plan and study with the copied actuals.

Viewing the Tracked Study Summary

1. On the Studies screen, select the checkbox of the study for which you want to view a summary.

2. Click Track and select View Summary.

   The Summary screen appears. The Summary screen provides an overview of the study's budget health.

   • For more information, see Evaluate your Study's Progress: Summary Tab.

Viewing Reports for a Tracked Study

1. On the Studies screen, select the checkbox of the study for which you want to view study reports.

2. Click Track and select View Reports.

   The Reports screen appears. The Reports screen provides reports you can view to evaluate your study's progress.

   • For more information, see Generate Tracking Reports: Reports Tab.

Working with Baseline Plans

This section provides information on how to work with baseline plans.

Setting the Baseline Plan

There are two methods for setting the baseline plan.

To set the baseline plan from the Plans screen:

1. From the Edit menu, select Plans.

   The Plans screen appears.

2. Select the checkbox of the plan.

3. Click Other Actions and select Set as Baseline.

   The Set Baseline dialog box appears.

4. From the Plan State drop-down list, select a plan state.

5. Click Ok.

   The application sets the plan as a baseline plan and locks the plan.

To set the baseline plan from the Studies screen:

1. From the Edit menu, select Studies.

   The Studies screen appears.

2. Select the checkbox of the study.

3. Click Track and select Enter Actuals.

   The Choose a Plan to use as Baseline dialog box appears.

   or

   The Edit Actuals screen appears, if there is only one plan available to set as the baseline plan.

4. Select the checkbox of a plan to set as the baseline plan.

5. Click Ok.

   The Edit Actuals screen appears.

6. Edit the fields as necessary. For more information about the field, click the field name.

7. Click Save.

Locking and Unlocking Baseline Plans

A baseline plan is locked by default when it is set as a baseline plan. You can unlock a baseline plan to edit the plan. Edits made to the baseline plan are reflected in the associated tracked study.

1. From the Edit menu, select Plans.

   The Plans screen appears.

2. Select the checkbox of a baseline plan. Baseline plans have a baseline status.

3. Click Other Actions and select Lock Plans or Unlock Plans.

Reforecasting Baseline Plans

You can reforecast a plan and set it as the baseline plan while tracking a study. Reforecasting allows you to model multiple assumption changes, with the impact being applied from a chosen point in time.

All sequential reforecasting events can be captured as the project progresses, allowing you to take into account the assumption changes that have occurred or are planned.

Reforecasting looks at tasks that are distributed over time and at the date you specify, and freezes the planned activity at that date.

Reforecasting a Baseline Plan

1. From the Edit menu, select Plans.

   The Plans screen appears.

2. Select the checkbox of the plan.

3. Click Other Actions and select Create Reforecast.

   The Create Reforecast dialog box appears.

4. In the Reforecast Name field, enter a reforecast name.

5. In the Reforecast Date field, select a reforecast date.

   The application calculates activities that have already occurred or costs that have already been incurred according to any tracking data available, allowing the application to predict the impacts of work remaining.

6. Select the radio button, either Actual Values or Planned Values.

7. Click Ok.

   The Edit Reforecast screen appears.

8. Edit the fields as necessary. For more information about a field, click the field name.

9. Click Save.

Setting the Reforecasted Plan as the Baseline Plan

1. From the Edit menu, select Plans.

   The Plans screen appears.

2. Select the checkbox of the plan you reforecasted. Reforecasted plans have a status of Reforecast Effective.

3. Click Other Actions and select Set as Baseline.

   A message appears, informing you that setting this plan as the new baseline allows you to track against the changes you made.

4. Click Ok.

   The reforecasted plan is set as the baseline plan.