View Major Tasks and Adjust Labor Fees on the Labor Tab

On the Labor tab, review the major tasks in the plan and adjust the calculated labor unit costs and unit hours for each service provider if necessary.

If you are licensed for an Enterprise edition, you also have the flexibility to create and edit major tasks and tasks, and to add and remove resources from tasks.

1. Click the Labor tab.

   Major tasks and their expected direct costs are associated with a specific service provider.

2. Choose a viewing option:
   • To view a provider's expected fees, in the Filter section, from the Show hours and fees for drop-down list, select the service provider.
   • To view all major tasks, even if no effort is expected for them for the chosen provider, select the Show major tasks with no planned effort for the selected provider check box.
3. Review the hour and cost information for the major tasks listed for the plan. You can:
   • Accept the calculated hours and costs, then click Next to advance to the Costs tab.
   • Adjust the hours or fees by selecting a major task then clicking the Adjust Hours or Fees button.
   • Add a major task by clicking the New Major Task button and following the instructions in Create a Major Task.

• Create a Major Task (Enterprise Edition Only)
  A major task is a ClearTrial term for a group of related tasks that share the same unit of measure, scope (location-scoped or study-scoped), and expected timeframe and distribution of units completed.
• Add a Task for a Major Task
  Tasks are activities performed to accomplish a major task. For each task, you can define its name, uniquely identify it with a code or mapping key, add it to an assignment group, and add resources.
• Configure Resources for User-defined Tasks
  Resources are the roles that people who work on the study are assigned. Associated with each resource are a code for tracking the resource through the study, a job title or classification, and a set of responsibilities.
• Create a Custom Level-of-Effort (LOE) Algorithm
  With the appropriate role granted, user-defined algorithms can be created when you have custom labor activities you need to account for in the budget.

Create a Major Task (Enterprise Edition Only)

A major task is a ClearTrial term for a group of related tasks that share the same unit of measure, scope (location-scoped or study-scoped), and expected timeframe and distribution of units completed.

By default, the major tasks you create appear below the ClearTrial-defined major tasks on the Labor tab in the order you create them. However, you can change the sort order for all major tasks and tasks to align with your custom work breakdown structure.

ClearTrial applies inflation to all major tasks, whether user-defined or ClearTrial-defined, based on the inflation settings on the Provider tab.

1. On the Labor tab, click the New Major Task button.
2. On the Task Manager screen, on the Major Task Details tab, define the basic attributes of the new major task.
   • Name—Oracle recommends naming the major task with the explicit deliverable or unit of work expected. Use a noun or noun phrase. Major task names must be unique within a plan.
   • Description—Oracle recommends providing a description to help others understand the purpose of the major task.
   • Location of Labor—Specify whether associated tasks vary by location (location-scoped) or are centralized (study-scoped).
     • 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, subjects, or visits in each location. Location-scoped tasks can be assigned to different service providers in different locations. For a location-scoped task, you can create different algorithms for each location to determine the level of effort required to complete the task in that location.
     • Study-scoped tasks can be assigned to only one service provider. Tasks that are performed as part of project initiation or as part of back-office operations are usually study-scoped and the unit of measure is usually the study itself. The unit of measure, also known as the work unit, should ideally be a value that does not vary by location; however, if you choose a value that varies by location as the unit of measure for a study-scoped major task, the number of units will be calculated as the sum across the locations in the trial.
   • Unit of Measure—From the drop-down list, select the unit of measure for this major task. Both ClearTrial default and user-defined units of measure are available from this list. You can create a custom field and specify it to be used as a work unit and those user-defined work units are distinguishable in the list from the ClearTrial-defined ones. ClearTrial calculates all effort for associated tasks in terms of how many hours it takes to complete one such unit of work.
     • The ClearTrial-calculated unit hours are multiplied by the number of units expected (for example, number of sites approved) to produce the Extended Unit Hours.
     • User-defined units of work appear in the drop-down list in italicized font followed by an asterisk so you can easily distinguish between custom and default units of measure.

       For example, a major task whose unit of measure is Sites Approved is composed of tasks whose resources level of effort are calculated as the number of hours required to approve one site. This level of effort (or LOE) represents the unit hours for the resource for the task.

       Note:

       Algorithms based on user-defined units of measure may become invalid if the Custom Field Model for the plan is changed.
3. Identify where to display the new major task. From the Display this Major Task drop-down list, select before or after. Then select the major task before or after which to display the major task.
4. Click Save.
5. Click Close or the New Task button to add a task to the new major task.

Add a Task for a Major Task

Tasks are activities performed to accomplish a major task. For each task, you can define its name, uniquely identify it with a code or mapping key, add it to an assignment group, and add resources.

1. On the Edit Plan screen, select the Labor tab.
2. Select the major task to which you want to add a task.
   • If you just created a new major task, on the Major Task Details tab, click New Task.
   • If you are adding a task to an existing major task, on the Labor tab, select the radio button of the major task to which you want to add a task, click Edit Major Task, then, on the Major Task Details tab, click the New Task button.
3. On the Task Details tab, specify the details about the task, keeping in mind that all tasks inherit some characteristics, such as unit of measure, labor scope, and distribution, from their major task.
   • Name—Enter a descriptive name for the task.
   • Grouping Code—Including a grouping code allows you to quickly identify, organize, and map tasks to align with another WBS. Grouping Code appears as a column on the Summary Grid report.
   • Mapping Key—ClearTrial assigns a unique value to identify this task.
   • Code—ClearTrial uses your entry as a prefix to the selected task name.
   • Sponsor Mapping Key—Enter a unique mapping key that will appear in a Sponsor Mapping Key column on the Summary Grid report.
   • Description—The text you enter appears as the help text for this task on the Assignment tab.
   • Assignment Group—The assignment group is represented by choices in the Responsibilities section of various tabs throughout the plan and in drop-down lists on the Assignment tab. By choosing the appropriate assignment group, you can determine whether a task is performed by the sponsor or CRO, or is not performed at all for this trial. You can also manage the assignments of each task on the Task Assignments tab on this Task Manager screen.
   • Summary Category—Your selection from the Summary Category drop-down list determines which summary group the task will be displayed in on the Summary tab.
   • Major Task—From the Major Task drop-down list, select the major task under which this task should appear.
   • Display this Task—To sort the tasks, from the drop-down list, select before or after. From the drop-down list to the right, select the task before or after which to display this task.
4. Click Save.
5. Add a resource by clicking the Add Resource button, selecting one or more resources, and then clicking Ok
6. Click Save.

   ClearTrial assigns the new task a mapping key. Editable mapping keys are included in the Bid Grid exported when you create an RFP to allow vendors to programmatically map their costs to the Bid Grid format.

7. Click the Task Assignments tab.
8. Select the Default Values check box to assign a default service provider and billing location for the selected task.
9. To include the location, select the Included check box.
10. For each location, select the service provider and billing rate location from the drop-down lists.
11. To prevent cascading changes, pin the service provider and billing rate location assignments by clicking the Pushpin icon in the Pinned column.
12. Add one or more resources by clicking the Add Resource button, selecting addition resources, and then clicking Ok, or click Save.
13. Click Close to return to the Edit Plan screen to add or edit a major task. Click Next to assign pass-through or other indirect costs for this study on the Costs tab.

Configure Resources for User-defined Tasks

Resources are the roles that people who work on the study are assigned. Associated with each resource are a code for tracking the resource through the study, a job title or classification, and a set of responsibilities.

1. On the Labor tab, select a major task, then click Edit Major Task.
2. Select the task whose resources you want to edit, then click Edit Task.
3. From the list of resources, select the Resource, and then click Edit Resource.

   ClearTrial displays information about the resource on four tabs (or three, if combined): Resource Details, Algorithm, Hours, and Rates & Substitutions. If your assigned ClearTrial system administrator has set the customer preference to combine the Algorithm and Unit Hours tabs, these two tabs are combined into just one tab called Algorithm / Hours. If you need information about a field, click its name.

   Tip:

   You can configure algorithms to calculate a resource's level-of-effort only for user-defined resources. You can adjust billing rate locations, billing rates, and unit hours for any resource.
4. On the Resource Details tab, specify the department to which this resource belongs and the GL code for the fees associated with this resource when performing this task.

   Different providers can use different names for the resources that perform tasks. Review and change the description to make sure it identifies the appropriate resource. For more information, see Add a User-defined Description for a ClearTrial-defined Resource.

5. On the resource Algorithm tab (or Algorithm / Hours tab), configure custom algorithms using multiple expressions (requires the Advanced Algorithm Editor additional role/capability) or via script (requires the Expert Algorithm Editor additional role/capability). The scripting language should only be used if your algorithm cannot be accomplished via the expression functionality. You can switch between scripted (Switch to Script) and expression (Use Expressions) modes.

   When working with multiple expressions, select the cost driver (also known as work unit), a percentage to apply to the cost driver, and the number of hours per that percentage of the work unit for each expression. The complete algorithm should produce the level of effort in hours for the selected resource to produce one unit of work (as defined by its major task).

6. On the Unit Hours tab (or Algorithm / Hours tab), you can override the ClearTrial-calculated unit hours for the selected resource. For location-scoped tasks, you can override the unit hours expected for each location.
   • You can override the default unit hours or the unit hours percentage adjustment for the selected resource for all unpinned locations.
   • Use the Unit Hours field to specify a specific number of hours.

     Oracle recommends using this option if you want the hours to remain the same even if the study assumptions change.

   • If you want hours to change as study assumptions change, use the % Adjust field for the selected resource to specify a percentage adjustment to be applied to calculated hours.
7. On the Rates & Substitutions tab, you can assign the billing rate location for the selected resource when working on this task and override the billing rates for the selected resource when performing the task.

   Each row displays the hourly billing rate for the selected resource based on its billing rate location.

   1. From the Billing Rate Location drop-down, select the location where this activity will be performed.
      • It is not necessary for the location to have active sites participating in the study. For example, you may have study sites in France, Germany, and Italy but perform all data management in the UK or India.
      • By default, ClearTrial calculates centralized tasks using the back-office billing rate location of the assigned provider.
   2. If the task is location-scoped, you can override the value in the Rate field for each location.
      • You can override the standard billing rate on a case-by-case basis. For example, a medical director might have a billing rate of $300.00 per hour. For a specific task, he or she bills at $500.00 per hour. If you enter $500.00 in the rate field for this task, the application uses the $500.00 per hour rate. All other tasks are calculated at $300.00 per hour.
      • If you have overridden the billing rate location, the rate displayed reflects that choice rather than the local rate.
   3. (Optional) Select a resource to substitute from the Substitute drop-down.
      • By default, the billing rate used is the effective billing rate, which can be overridden at the plan level or plan-location level of the selected resource.
      • 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 for the selected resource when performing the work of the original resource.
   4. (Optional) Use the % Adjust field to specify a percentage adjustment to the rate for a selected resource on a case-by-case basis.
   5. To prevent cascading changes, pin the billing rate location assignment, substitute resource, and billing rate by clicking the Pushpin icon in the Pinned column to highlight it.

      Note:

      Changes made to the billing rate location for the task or task group assignments do not override pinned billing rate locations for this resource for this task. Also, changes made to the billing rate or resource at the plan level or plan-location level do not override pinned billing rates or substitutions for this resource for this task. However, pinned settings are lost if the associated location and/or service provider are removed from the plan.
8. Click Save.
9. Click Close.

Create a Custom Level-of-Effort (LOE) Algorithm

With the appropriate role granted, user-defined algorithms can be created when you have custom labor activities you need to account for in the budget.

Multiple-expression algorithms can be used to calculate the level of effort required for a resource to complete a task.

1. From the Labor tab, click Create New Major Task or select a major task from the list and click Edit Major Task.
2. From Task Manager, select a major task from the left panel, to display its tasks on the Major Task Details tab in the right panel, and then click New Task or select a task and click Edit Task.
3. On the Task Details tab, click Add Resource to add a resource to the plan.
4. On the Algorithm tab, define a custom algorithm using multiple expressions or the scripting language.
   • Use the scripting language only if your algorithm cannot be accomplished via the expression functionality. You can switch between scripted and expression modes by clicking the Switch to Script and Use Expressions links.
   • When working with multiple-expressions, select the cost driver, a percentage to apply to the cost driver, and the level of effort in hours for the selected resource to produce one unit of the particular work product.
     • You can create algorithms with up to eight individual expressions. Each expression within the algorithm has the ability to use a different cost driver, percentage to apply to the cost driver, and level of effort in hours.
     • If you have specified the cost as location-scoped, then you can define an algorithm for each location or use the default algorithm for one or more locations.
   1. In the Calculate as field, specify the number of hours (per a percentage of the cost driver) the resource must spend to complete one unit-of-measure for the expression.
   2. In the per field, specify the percentage value to apply to the selected cost driver for the expression.

      This percentage will increase/decrease the number derived from the underlying assumption for the driver.

   3. In the of field, select the unit-based assumption to drive the calculation for the expression. User-defined work units appear in the of drop-down list in italicized type followed by an asterisk.
   4. Click Save.
   5. Click Add another expression to add up to eight expressions.

      ClearTrial evaluates each expression by multiplying the number of units derived for the chosen assumption by the percentage and hours entered.

      The value of each expression within the algorithm is totaled to calculate the level of effort in hours for the selected resource to produce one unit of the particular work product.

      Changes to assumptions that result in an increase or decrease in the number of units for the chosen assumption automatically adjust the cost or hours.

      Note:

      While defining an algorithm, review the extended hours column to ensure that you have chosen the correct cost driver. An incorrect cost driver can greatly skew the effort estimated to complete a task.

      Generally, algorithms should avoid using the same work unit defined as the unit of measure for the associated major task. Level-of-effort algorithms should return unit hours, not total hours, for the task.

5. Click Save.
6. Click Close.