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Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide
Release 5.1

Part Number E36710-03
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18 Labor Tab

The Labor Tab is used to view and adjust the calculated labor unit costs or unit hours for each major task, or unit, for each service provider. This tab can be used to align your plan with the study's contract, bid, and internal tasks and costs.

This tab also allows you to launch Task Manager, where you can add and/or edit major tasks, tasks, resources, assign project tasks to specific service providers and billing rate locations, and override unit hours and the billing rate of a specific resource.

Adjusting Unit Hours and Fees

The Labor Tab allows you to adjust unit hours and fees for ClearTrial defined major tasks with the Adjust Hours or Fees button.

The Adjust Hours or Fees button displays a dialog screen for the selected major task and service provider, if you are a Standard Edition user. Enterprise Edition users can adjust hours and fees within Task Manager by selecting the Adjust Hours or Fees button or launching Task Manager.

To adjust hours or fees for a major task:

  1. Navigate to the Labor Tab.

  2. Select a major task and click the Adjust Hours or Fees button to display the dialog screen.

    If you are a Standard Edition user, the Adjust Hours or Fees dialog is displayed. If you are an Enterprise Edition user, the Major Task Adjustments Tab in Task Manager is displayed.

  3. Within the Adjust Hours or Fees dialog, in the Hours row, enter either a value in hours in the Per Unit field or a percent adjustment in the% Adjustment field. In the fees row, enter either a value in hours in the Per Unit field or a percent adjustment in the% Adjustment field. Adjust each location as needed.

  4. In the Major Task Adjustments Tab, within Task Manager, select the arrow for a location that needs to be adjusted. Clicking the arrow allows you to modify the number of units, unit hours, and unit costs for that major task. Adjust each location as needed.

    Next, navigate to the Major Task Distribution Tab to modify the distribution method for the Service Provider completing work on the assigned major task.

  5. Click Save.

Bulk Pinning Labor for Major Tasks

The Labor Tab allows you to pin, or save, all major task adjustment values for a major task by selecting the Pin Labor link above the major task list. The Pin Labor link allows you to bulk pin labor for all of the major tasks in a plan.

Pinning Labor for Major Tasks

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.

To bulk pin labor major tasks in a plan:

  1. Navigate to the Labor Tab.

  2. Click the "Pin Labor" link. Click OK to confirm you wish to pin all labor units, costs, hours, and distributions.

Unpinning Labor for Major Tasks

The Labor Tab allows you to unpin all major task adjustment values by selecting the Unpin Labor link above the major task list. When labor is unpinned, the major task adjustments will be recalculated to reflect the plan's original major task number of units, unit hours, unit cost, and distribution.

To unpin labor for a major task:

  1. Navigate to the Labor Tab.

  2. Click the "Unpin Labor" link. Click OK to confirm you wish to unpin all labor units, costs, hours, and distributions.

Task Manager

To increase control over budgeting capabilities, user-defined major tasks and tasks can be created using Task Manager on the Labor Tab. The Labor Tab is used to view and adjust the calculated labor unit fees or unit hours for each major task, or unit, for each service provider.

Task Manager allows you to add and edit major tasks, tasks, resources, assign project tasks to specific service providers and billing rate locations, and override unit hours and the billing rate of a specific resource.

Definition of a Major Task

In ClearTrial, a major task is a collection of related tasks that share the same unit of measure, labor scope, and expected distribution of units completed. Major tasks have three basic attributes:

  • Labor Distribution: Labor Distribution of a major task determines whether its associated tasks are expected to be performed in a centralized location or multiple locations at which sites and subjects are found.

  • Cost Allocations: Cost allocations allow you to spread costs evenly between two milestones or distribute the labor costs by a curve, such as subject enrollment.

  • Unit of Measure (Unit of Work): The unit of measure is calculated in terms of hours required to complete one unit of the major task.

Roles

To work with Task Manager, you must have either the WBS Editor or WBS Manager additional roles/capabilities assigned. Users without these roles cannot create user-defined major tasks. These are additional roles that can be granted by your System Administrator.

Searching for Major Tasks

A search box appears above the navigation panel and allows locating a major task or task quickly. Type one or more characters into the field and either click the icon or press the “Enter” key. The screen displays the total number of matches found for the keyword. The matches are highlighted and you can navigate through the list of occurrences by clicking on the “previous” or “next” links.

Task Manager Tabs

Within Task Manager, there are three tabs that are used for creating new major tasks and editing major tasks.

  • Major Task Details Tab: This tab is used to define the basic attributes of a major task. When a new major task is created, you must specify the name, unit of measure, labor scope, and units distribution.

  • Major Task Adjustments Tab: This tab allows you to edit the number of units, unit hours and unit costs for a specific major task.

    The major task unit adjustment capability is available for all system defined and user-defined major tasks, except for the Site Approved, Subject/Volunteer Randomized, and Monitored Clean CRF Pages Major Tasks. These major tasks can be aligned to your study's contract, bid, and internal tasks and costs by adjusting the unit hours and unit costs by location and by provider.

  • Major Task Distribution Tab: This tab allows you to edit the distribution method for the Service Provider completing work on the assigned major task.

    The major task distribution adjustment capability is available for all system defined and user-defined major tasks, except for the Site Approved, Subject/Volunteer Randomized, and Monitored Clean CRF Pages Major Tasks. These major tasks are limited to distribution adjustments at a by location level only.

Location-Scoped vs. Study-Scoped Tasks

Location-scoped tasks can be assigned to different service providers in different locations. Tasks that are performed locally, such as monitoring or other site visits, are location-scoped and are usually measured in terms of the number of sites or visits in each location. Study-scoped tasks can only be assigned to one service provider.

For a location-scoped task, you can create different algorithms to determine the level of effort required to complete the task in that location. Tasks that are performed as part of project initiation or as part of back-office operations are usually study-scoped and the only relevant unit of measure is the study itself.

Note:

Labor-scope cannot be changed for major tasks defined in the prior forecast when creating a reforecast.

Working with User-Defined Major Tasks

Task Manager allows you to edit and create user-defined major tasks.

Creating User-Defined Major Tasks

Creating user-defined major tasks involves specifying attributes for a major task and then assigning tasks beneath it to complete the work. The tasks have service provider(s) and billing rate location(s) assigned to them, as well as resources that are expected to complete the work.

When user-defined major tasks are added, they appear beneath the ClearTrial defined major tasks on the Labor Tab in the order they were created. They are also listed on the Payments Tab and on all pertinent reports.

To create a user-defined major task:

  1. Navigate to the Labor Tab.

  2. Click the New Major Task button to display the Task Manager. The Major Task Details, Adjustments, and Distribution Tabs are shown.

    On the Major Task Details Tab, enter a name and description. Specify if the labor is going to be varied by location or centralized. ClearTrial considers tasks as being location-scoped or study-scoped; see “Location-Scoped vs. Study-Scoped Tasks” for more information. Select a Unit of Measure from the drop-down menu.

    Note:

    Consult with your Clinical Services Manager if the Unit of Measure is not applicable to your major task.
  3. Click Save.

    Now that your major task has been defined and created, you can begin assigning tasks by selecting the New Task button. You can search for major tasks and tasks with the navigation panel in Task Manager. See Searching for Major Tasks for more information.

  4. Next, go to the Major Task Adjustments Tab to adjust the number of units, unit hours, and unit costs for providers assigned to this major task.

  5. Navigate to the Distribution Tab to edit the distribution method for the Service Provider completing work on the assigned major task.

  6. Click Save.

Editing User-Defined Major Tasks

User-defined major tasks be edited with the Task Manager.

To edit a user-defined major task:

  1. Navigate to the Labor Tab.

  2. Select the major task you want to edit and click the Edit Major Task button.

  3. Make your changes and click Save.

Deleting User-Defined Major Tasks

Major tasks created by users can be deleted with the Task Manager (ClearTrial defined major tasks cannot be deleted).

To delete a user-defined major task:

  1. Navigate to the Labor Tab.

  2. Select the Major Task you want to delete and click the Delete Major Task button.

Working with Tasks

User-defined major tasks and ClearTrial defined major tasks can have tasks added beneath them in order to assign work to be completed. Tasks can be modified and deleted from Task Manager on the Labor Tab.

Creating Tasks

To create a task:

  1. Navigate to the Labor Tab.

  2. Select the major task for which you want to add a new task and click the Edit Major Task button to launch the Task Manager.

  3. On the Major Task Details Tab, click the New Task button to display the Task Details and Task Assignments Tabs. Enter the task name, code, and description. Specify the Assignment Group and the Summary Category that the task belongs to from the drop-down menus.

    Assignment Groups are represented by radio-button choices in the Responsibilities section of various tabs throughout the plan and as drop-down lists in the Assignment Tab. You can determine whether a task is performed by the sponsor or an external vendor (CRO) (or is not performed at all for this trial) by choosing the appropriate radio-button for its assignment group.

    You can also manage the assignments of each specific task on the Task Assignments Tab in the Task Manager or in the Assignment Tab.

  4. Click Save and go to the Task Assignments Tab to assign the task to a service provider and billing rate location.

  5. After you enter information for the task, you can add resources by selecting the Add Resource button to display a list of resources. To add one, click the check-box and click OK.

Deleting Tasks

Tasks that have been assigned to major tasks can be deleted with from the Task Manager.

To delete a task:

  1. Navigate to the Labor Tab.

  2. Select a major task to edit and click the Edit Major Task button to launch the Task Manager.

  3. Select a task and click the Delete Task button.

Editing Tasks

You can edit task descriptions and assign resources with the Task Manager. You can also adjust the default billing rate for resources performing the task.

To edit a task:

  1. Navigate to the Labor Tab.

  2. Select a major task to edit and click the Edit Major Task button.

  3. Select a task and click the Edit Task button.

  4. Make your changes and click Save.

    Task Manager allows you to only edit task descriptions for user-defined tasks and major tasks.

To modify task descriptions:

  1. Navigate to the Labor Tab.

  2. Select a major task to edit and click the Edit Major Task button. Tasks for this major task are listed on the Major Task Details Tab.

  3. Select a task and click the Edit Task button to view the Task Details Tab. From this tab, you can edit the task description.

Pinning Service Provider and Billing Rate Location Assignments

While working with the Task Assignments Tab in Task Manager, you can save the service provider and billing rate location assignments for tasks by clicking the pin icon. Pinning allows you to protect and ensure that your current task assignments will not be lost due to other changes.

For example, changes made to the group of tasks, such as assignment groups on the Assignment Tab, will override the assignments made for individual tasks included in the group if the latter changes are not pinned. Any changes made to tasks are “pinned” by default.

The order of precedence for pinning is as follows:

  1. Assignments made at the task-resource level.

  2. Assignments made at the task level.

  3. Assignments made at the Assignment group level.

  4. Location assignments made at the plan level.

  5. All location assignments made at the plan level.

Working with Resources

In Task Manager, resources are assigned to tasks to allocate work to be completed. Resources can be added to tasks that are assigned to user-defined major tasks or ClearTrial defined major tasks.

Add a Resource to a Task

Resources can be assigned to tasks in the Task Manager. You can also specify resource details, algorithms, unit hours and billing rate locations for resources.

To add a resource:

  1. Navigate to the Labor Tab.

  2. Select the Major Task and click the Edit Major Task button.

  3. On the Major Task Details Tab, click the Edit Task button to view the Task Details and Task Assignments Tabs. In the Task Details Tab, click the Add Resource button and select a resource. Click OK.

  4. Click Save. Select the resource and click the Edit Resource button to view the resource tabs. For more information about the functions of each tab, see Resource Tabs below.

  5. Modify the resource on each tab as needed and Click Save.

Resource Tabs

When adding resources to tasks in Task Manager, you can specify information about each resource with the tabs described below.

  • Resource Details: Select a department name from the drop-down menu. The department is the name of the department to which this resource belongs when performing this task.

    Note:

    If the Major Task you are editing is ClearTrial defined, you will not be able to select a department.
  • Algorithm: Specify the cost driver and the level-of-effort in hours for the selected resource to produce one unit of the particular work product (major task unit-of-measure). You can only define algorithms for resources you add. System-defined algorithms cannot be depicted.

  • Billing Rate Location: Assign the billing rate location for the selected resource. You may select any location where this activity or activities will be conducted. It is not necessary for the location to have active sites participating in the study.

  • Rates & Substitutions (Billing Rates Overrides Tab): Override billing rates for the selected resource when performing a specified task. If the task is location scoped, you can override the rate for each location. Each row displays the hourly billing rate for the selected resource based on the applicable billing rate location, which may differ from the location listed. You can also substitute resources on this tab.

  • Unit Hours: Observe and/or override system-calculated unit hours for the selected resource. For location-scoped tasks, you can override the unit hours expected for each location.

Delete a Resource from a Task

Resources that have been assigned to tasks can be deleted by using the Edit Task button.

To delete a resource:

  1. Navigate to the Labor Tab.

  2. Select a Major Task and click the Edit Major Task button.

  3. Select the task with the resource assigned to it that needs to be deleted and click the Edit Task button.

  4. Click the resource you need to delete and click the Delete Resource button.

Edit a Resource for a Task

Resources that have been assigned to tasks can be edited using Task Manager. You can modify billing rates, billing rate locations, and substitute resources at the task level.

Modify the Billing Rate of a Resource

To modify the billing rate of a resource:

  1. Navigate to the Labor Tab.

  2. Select a major task to edit, and click the Edit Major Task button.

  3. Select a task to modify the billing rate of its resource and click the Edit Task button. Click the resource you want to edit and select the Edit Resource button. Navigate to the Rates & Substitutions Tab.

  4. On the Rates & Substitutions Tab, you can use the Rate and% Adjust columns to modify the billing rate for the resource. You can edit the predefined ClearTrial numbers by entering your own information into these columns. When finished, click Save.

Modify the Billing Rate Location of a Resource

To modify the billing rate location of a resource:

  1. Navigate to the Labor Tab.

  2. Select a major task to edit, and click the Edit Major Task button.

  3. Select a task to modify the billing rate location of its resource and click the Edit Task button. Click the resource you want to edit and select the Edit Resource button. Navigate to the Billing Rate Location Tab.

  4. On the Billing Rate Location Tab, you can override the billing rate location by selecting different locations from the drop down menu. In order to save your overrides, you can click the pin icon in the pinned column. This column displays an icon that you can click to protect, or “pin”, your current settings for this resource for this task.

  5. When the icon is blue, the billing rate location is pinned, and changes made at more general levels will not affect that value. For example, changes made to the billing rate location for the task or task group assignments will not override pinned billing rate locations for this resource for this task.

    Note:

    Your pinned settings will be lost if the associated locations and/or service providers are removed from the plan. However, if you replace a provider, your pinned settings are maintained and transferred to the replacement.
  6. Click Save.

Substitute a Resource

To substitute a resource:

  1. Navigate to the Labor Tab.

  2. Select a major task to edit and click the Edit Major Task button.

  3. Select the task with the resource that needs to be substituted and click the Edit Task button. Highlight the resource to edit and click the Edit Resource button. Navigate to the Rates & Substitutions Tab.

  4. On the Rates & Substitutions Tab, you can substitute resources with the Substitute column. This column allows you to select a different resource to perform this task in the listed location. By default, the billing rate used will be the effective billing rate (which may have been overridden at the plan level or plan-location level) of the selected resource.

  5. If resource substitutions have also been made at the plan level or plan-location level for the assigned service provider, the default effective billing rate is defined as the rate specified in that context as the rate for the selected resource when performing the work of the originally expected resource.

  6. Click Save.