Configure Indirect Costs on the Costs Tab

By default, the Costs tab of a plan displays the pass-through and miscellaneous costs calculated for the plan. Some of these costs are pre-calculated. Other costs are displayed as place-holder costs based on ClearTrial's embedded intelligence.

1. Select the Costs tab.
2. Choose which costs to display:
   • To display only cost categories with a value, clear the categories where costs total 0.00 filter option.
   • To display cost values for each location and assignments, select the per location values and assignments filter option. This will allow you to view all costs in the list by location and toggle through their provider, department, and GL Code assignments.
   • To display excluded costs as well as included costs in the list, select the Show excluded costs filter option.
     • If you exclude a cost, but it no longer includes the amount in the plan and its totals, the costs appear with a line drawn through them.
     • Restore an excluded cost by selecting the check box to the left of an excluded cost, and clicking Include.
   • If none of the predefined cost categories adequately captures the nature of a cost that should be included in the estimate for the plan, you can add a new cost.
3. You can accept the costs shown as is, add a cost that is needed, or review the costs and make adjustments to the algorithm and distribution. For instructions, see Create User-defined Indirect Costs.

• Create User-defined Indirect Costs
  On the Costs tab, enter information about the new cost on the Definition, Assignments, Algorithm, and Distribution tabs.
• Enter Cost Category Information
  Define the cost by categorizing the cost as pass-through, miscellaneous, or associated with a specific department and a GL code.
• Assign Costs to Service Providers
  After you have defined the category for the new indirect cost, select the Assignments tab the assign the cost to specific service providers.
• Distribute the Cost
  On the Distribution tab, select how the cost will be distributed for each location in your plan or study-wide.

Enter Cost Category Information

Define the cost by categorizing the cost as pass-through, miscellaneous, or associated with a specific department and a GL code.

1. Open the Costs tab and select the New button to display the Definition tab on the Define New Category screen.
2. In the Category Information section, in the Name field, enter a name for the cost. For any user-defined cost, specify a name of up to 60 characters that is unique for this plan. However, you cannot change the name of a ClearTrial-defined cost.
3. From the Type drop-down list, select the cost type.
   • Pass Through—These costs are incurred by an outsourced partner and will be passed through to the sponsor for reimbursement.
   • Miscellaneous—These costs are incurred by the sponsor as part of the overall study budget.
4. Specify whether the cost varies by location or will be the same for all locations.

   If you select Costs vary by location, you can specify a different amount for each location, assign the responsibility for the cost to a different provider for each location (on the Assignments tab), override the start and end dates over which to distribute the costs (on the Distribution tab), and express the cost in a different currency for one or more locations (Algorithm tab).

5. To make this cost part of the recurring payments plotted on the Cash Flow Chart, select the Include in Payment Schedule check box. ClearTrial assumes the cost is paid out monthly between the specified start and end dates. You can change the frequency of the payment for each cost on the Payments tab by clicking Edit Recurring Payments.
6. To treat indirect costs as billable items or to allocate one or more resources to manage the costs, select the Include in Resources by Department/GL Code report check box. To include inflation for this cost in resulting calculations, select the Apply inflation over time check box.
7. To treat his as a credit item and disable the Include inflation in results option, select the Treat as Credit check box.
8. In the Notes section, enter details or comments about the new cost category. ClearTrial displays these notes as the help content for this cost.
9. Note the History section that shows who created the new category and when as well as who last modified it and when.
10. Click Save.

    ClearTrial assigns the new cost a mapping key. Mapping keys are included in the Bid Grid export to allow vendors to programmatically map their costs to the Bid Grid format.

11. Continue to define the new cost category by assigning costs to service providers on the Assignments tab, calculating algorithms on the Algorithm tab, and specifying how to distribute costs on the Distribution tab.
12. Click Close. To specify the payments schedule, click Next to open the Payments tab.

Assign Costs to Service Providers

After you have defined the category for the new indirect cost, select the Assignments tab the assign the cost to specific service providers.

1. Click the Assignments tab.
2. For each location or for the entire study:

   select the service provider, department, and GL Code from the drop-down lists.

   1. Select the responsible service provider or vendor from the Provider drop-down list.
   2. Map the cost to a specific department you select from the Department drop-down list.
   3. Map the cost to a specific code in the General Ledger by selecting it from the GL Code drop-down list.
3. Click Save, and then select the Algorithm tab.

Distribute the Cost

On the Distribution tab, select how the cost will be distributed for each location in your plan or study-wide.

1. On the Define New Category screen, after providing basic information on the Definition tab, assigning the cost to a service provider on the Assignments tab, and creating a custom algorithm on the Algorithm tab, select the Distribution tab.
2. From the Distribute according to drop-down list, select a predefined schedule or a custom approach to distributing the cost for each location in the plan.
   • If you select the Site Approval Distribution, Subject Enrollment Distribution, or CRF Data Distribution, in the and shift field specify an offset for the selected ClearTrial-defined distribution curve. You can shift a distribution to occur up to 999 days earlier or later than originally defined.
   • Select An Even Distribution to 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, are modified accordingly.
   • Select A Custom Distribution to enter an absolute value per period between available milestones and an optional off-set timeline period or interval. From the by drop-down list, select Week, Month, or Quarter.
3. In the Default range field, define a Start and End milestones for the cost distribution. These are used as the default start and end date for each location and specifies whether the offset is before or after the selected milestone.
   • Select a milestone to which to anchor the start and end of the cost distribution. You can start the cost on this milestone or some number of days before or after this milestone. Changes to the assumptions in this plan that revise the predicted milestone date automatically revise the distribution of this cost. However, the calculated distribution start date cannot be earlier than the pre-study planning date.
   • For example, you can indicate that a cost is expected to spread from 30 days prior to FSI to 15 days after LSO.

   Note:

   You can distribute the cost up to 10 years after the Final Report date. The calculated distribution end date must be less than the Final Report date plus 10 years.
4. Click Save & Close to return to the Costs tab.