Define Outsourced Tasks on the Assignment Tab

On the Assignment tab, select which location the assignments apply to and a default service provider for outsourced tasks, then, for each task or assignment group, assign a service provider and billing rate location.

Note:

Tasks are added to the ClearTrial Work Breakdown Structure (WBS) with the ClearTrial Task Manager. Enterprise-licensed users can launch the Task Manager by clicking New Major Task or Edit Major Task from the Labor tab of a plan.

Select the location and default service provider for outsourced tasks

1. Select the Assignment tab.
2. In the Task Assignments section, from the Values apply to drop-down list, select the location to assign responsibility for a specific service provider to a specific country or region.
   • Select Centralized Tasks/Location Defaults if you want assignments to pertain to every location in the study.
   • Otherwise, select a specific location.
3. Choose the default service provider for outsourced tasks from the Default Service Provider for outsourced tasks drop-down list.
   • If all outsourced tasks are to be performed by a single service provider, select that service provider.
   • If outsourced tasks in the plan are performed by various service providers, select the service provider who performs most of the outsourced work.

     Examples

     • Example 1: If Values apply to is set to Centralized Tasks/Location Defaults, to assign all outsourced tasks for all locations to Major CRO, select Major CRO.
     • Example 2: If Values apply to is set to a country, for example, Chile, to assign all outsourced tasks in Chile to Medium CRO, select Medium CRO.
   • If a service provider is not available for selection, return to the Provider tab and add the service provider.
4. Click Save.
5. If a list of assignment groups and tasks doesn't appear at the bottom of the screen, click the Show Tasks link.
6. To see and assign individual tasks, click the triangle to the left of the assignment group or task.
   • To expand all task groups, in the table header bar, double click in the space to the left of the Assignment Group/Task column header.
   • The Included column, which appears only if you expand the task groups, indicates whether this task is included in the study and allows you to exclude a task from the study. If this check box is grayed out, the task must be included (or excluded) from the plan based on other input assumptions you have made or other study characteristics.
   • You can exclude selected tasks from the plan, which eliminates the effort and costs associated with these tasks. Tasks that cannot be excluded or specifically assigned, or whose billing rate location cannot be different from the location of subject data, are presented with the associated option(s) disabled.
   • If, on the Overview tab, you selected Outsourced, you can only assign tasks to a vendor. If you selected Conducted Internally, you can only assign tasks to the sponsor. To assign some tasks to service providers and others to the sponsor, you must select Combination on the Overview tab.
7. For each entry in the Assignment Group/Task column, from the Assign to drop-down list, select the service provider.

   The value displayed might indicate additional information when showing the assigned provider(s) for an entire group of tasks, as follows:

   • Service provider name appears with no additional markers—All tasks in the group are performed by a single service provider.
   • Service provider name appears with an asterisk (*)—The service provider is the default service provider selected to perform tasks in the group, but some tasks are assigned to another provider.
8. From the Billing Rate Location drop-down list, select the billing rate location to use to calculate resource costs for this task or group of tasks.
   • You can specify a different billing rate location for each task group or individual task. For example, if data management tasks for all European sites are performed in Germany, change this field to Germany for each of the locations in Europe.
   • You can select any location where this activity or activities are conducted. The location does not need to have active sites participating in the study. For example, you might have study sites in France, Germany, and Italy, but perform all data management in the UK or India.
   • To choose a location that does not have sites or subjects, from the drop-down list, choose Other.... Choose the location where the work is performed (or from where the resources who will perform the task will come), and then click Ok.
   • By default, centralized tasks are calculated using the back office billing rate selected on the Provider tab.
9. To prevent cascading changes, pin the Service provider and billing rate location assignments by clicking the Pushpin in the Pinned column to highlight it.
   • As a reminder, the primary provider is distinguishable from other providers on the Provider tab by the ** next to its name.

     For example, if assignments made for individual tasks included in the group are not pinned, changes made to the assignment group or to the location defaults override these assignments.

   • Pinned settings are lost if you remove the associated locations or service providers from the plan. However, if you replace a provider, your pinned settings are maintained.
   • Task overrides migrated from plans created in earlier versions of the application are pinned by default.
   • If an assigned provider is deleted from a plan, the task is automatically assigned to the primary provider in the plan.
10. Click Save.
11. Repeat as necessary for multiple locations where the service provider is different or the billing rate is different from the local rate for that location.
12. Override selected resources and rates or click Next to view or adjust labor fees.

• Override Resources and Rates
  You can specify substitutions for each resource and/or override the billing rate location and rate by location, per provider.

Override Resources and Rates

You can specify substitutions for each resource and/or override the billing rate location and rate by location, per provider.

Show me how!

1. Select the Assignment tab.
2. Click Save to save any changes you have already made.
3. In the Task Assignments section, click the Override Resources or Rates link.
4. On the Resource Overrides screen, in the Scope of Overrides section, from the For tasks assigned to drop-down list, select a service provider.
5. In the Resources / Overrides section, specify your override for each default resource specification and pin your changes if desired. If you pin your changes, ClearTrial uses these choices throughout the plan instead of its defaults.
6. Click Save & Close.
7. Perform additional overrides, or click Next to view or adjust effort and labor fees.