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Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.0 E36710-02 |
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# 20 Costs Tab

The Costs Tab allows you to edit cost details and create user-defined costs for studies. You can also include and exclude costs for a plan.

The Costs Tab displays a list of pass-through and cost categories that can be adjusted based on your plan assumptions. Some of these costs are pre-calculated, while the rest are assumed study costs that cannot be derived from study characteristics or your assumptions.

## 20.1 Including and Excluding Costs

The Costs Tab allows you to include and exclude costs from a study. To exclude a cost, select one or more costs and click the Exclude Cost(s) button.

Excluded costs are not deleted, but their amounts are not included in the plan totals. Excluded costs can be restored by selecting the checkbox to left of each excluded cost and clicking the Include Cost(s) button.

## 20.2 Inflation

The Costs Tab allows you to include or exclude inflation for selected pass-through and miscellaneous costs across the length of the trial on all reports that display the cost. You can choose to exclude inflation by clicking on the Edit Cost button and uncheck the inflation checkbox.

## 20.3 Working with Costs

Costs can be created and edited on the Costs Tab.

### 20.3.1 Adding New Costs

To add a new cost:

1. Navigate to the Costs Tab.

2. Click the New Cost button. On the Definition Tab, enter a cost name and select the cost type, pass-through or miscellaneous. Select a Department and GL Code for the cost. Determine if you want to include inflation, include this cost in the payment schedule, and/or include it in the Resources by Department Report. You can also treat the cost as a credit. Click Save.

3. Navigate to the Algorithm Tab. Indicate if this cost varies by location or at the study level. If the cost varies by location, use the “Calculate as” field to specify a per unit cost. This value will be the default for each location if you have chosen to vary this cost by location.

   The total value for each location, or the study-level cost, is calculated as this value multiplied by the number of units expected for the chosen assumption.

   Next, specify the currency in which you have expressed a per unit amount. Editing this field will not convert a previously entered value. It is assumed the value you have entered is expressed in the chosen currency.

   When the currency is edited, the change is applied to the location-specific costs unless those costs have been overridden to vary from the amount and currency entered in this section.

   Then, select a unit-based assumption by which to drive the calculation of this cost. The number of units derived for the chosen assumption is multiplied by the amount entered to produce the total cost. Changes to assumptions that result in an increase or decrease in the number of units for the chosen assumption are adjusted for this cost.

   Click Save.

4. The Distribution Tab allows you to determine how costs will be distributed for each location in your plan with the “Distribute according to:” field. The options for cost distribution include:

   - Spread costs according to one of the pre-defined schedules: Site Approval Distribution, Subject Enrollment Distribution, or CRF Data Distribution.

   - Spread costs evenly between two dates, based on available milestones and optional off-set in days prior to or past the occurrence of that milestone. When assumptions in the plan change, the predicted date of these milestones, and the distribution of the costs, will be modified accordingly.

   - Spread costs according to a custom distribution where you can enter an absolute value per period between available milestones and an optional off-set. Custom Distribution timeline period, or intervals, include: week, month, and quarter.

5. Click Save.

### 20.3.2 Editing Costs

To edit a cost:

1. Navigate to the Costs Tab.

2. Select a cost and click the Edit button.

3. Make changes as needed and save.

### 20.3.3 Deleting Costs

To delete a cost:

1. Navigate to the Costs Tab.

2. Select one or more costs and click the Delete button.