| Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.4 E63096-01 |
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Home > Plan and Source User Guide > Maintaining Resource Inform...
| Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.4 E63096-01 |
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Home > Plan and Source User Guide > Maintaining Resource Inform...
This chapter covers the functions available to manage resource information in the application.
You maintain templates, service providers, resources, billing rates, inflation rates, departments and functional areas, GL codes, exchange rates, and reporting regions from the Maintain menu. You can also purge deleted items.
Using a template to create a plan saves time by storing frequently used values and choices. Templates also enforce standard operating procedures. Unlike a copy of a plan, which remains linked to its original study, you can create a plan based on a template for any study.
From the Maintain menu, select Templates.
The Templates screen appears.
Filter the templates as necessary. For more information, see Define Template Filter Dialog Box Fields.
On the Templates screen, click New.
The Select Template Defaults dialog box appears.
Select the sponsor, phase, therapeutic area, and indication from the drop-down lists.
These are the defaults the application uses to calculate suggested values when you create a plan based on this template. You can override these values in your plan, or change the defaults by editing the template.
Choose values that correspond to most of the plans to which this template will apply. You can then modify the plan as necessary.
You can select this template to plan studies even if the study to be planned is for a different phase, therapeutic area, or indication.
For more information about a field, click the field name.
For more information about the screen, see Select Template Defaults Dialog Box Fields.
Click Ok.
The Create Template screen appears and is identical to the Plans screen. Enter values as you would for any plan.
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Note: The new template will be created using the cost model for the current release. If the cost model used by the template needs to change, you can make that change through the Change Attributes option. For more information, see Changing Template Attributes. |
Enter or override the information shown on the Overview tab.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Plan or Template Screen (Overview Tab).
Click Next to display the next tab or click a specific tab. Grayed-out tabs are not available.
Work through the tabs until you have completely defined the template.
Click Save.
Revise the values as you would for any plan.
On the Templates screen, select a template checkbox and click Edit.
The Edit Template screen appears and is identical to the Edit Plan screen. The application displays the cost model version associated with the template in the upper right-hand corner.
On the Overview tab, edit the information.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Plan or Template Screen (Overview Tab).
Step through the rest of the tabs by clicking Next or a specific tab. Grayed-out tabs are not available.
Add a note. For more information, see The Notes Feature Allows You to Annotate Every Page of Your Plan.
To save the changes to the template, click Save.
The application does not remove deleted templates permanently until a later time. You can restore a deleted template prior to that time.
On the Templates screen, select the checkbox of the template to delete.
Click Delete.
On the Templates screen, in the Filter section, select All Templates.
Deleted templates appear with a line through them.
Select the checkbox of the deleted template to restore.
Click Restore.
The application removes the line and makes the template active..
On the Templates screen, select the checkbox of the template to copy.
Click Copy.
The Copy Template dialog box appears.
Provide a name for the copy.
Click Ok.
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Note: The new template inherits the cost model from the source template. |
Locking a template freezes the template. It can no longer be edited.
On the Templates screen, select the checkbox of the template to lock or multiple checkboxes.
From the Other Actions menu, click Lock Templates.
A lock icon appears to the right of the checkbox. You cannot edit a locked template.
Unlocking a template allows the selected template to be edited.
On the Templates screen, select the checkbox of a locked template.
From the Other Actions menu, click Unlock Templates.
The application unlocks the template and deletes the lock icon.
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Note: If the template being unlocked has a cost model version earlier than the 5.3 cost model, the template will be automatically upgraded to use the 5.3 cost model when it is unlocked by the application. Even though you are able to change the cost model used by an unlocked template (see Changing Template Attributes), you will not be able to reassign the template back to a cost model that is older than 5.3. |
You can change the name, status, cost model, custom field model, and descriptions of a selected template.
On the Templates screen, select a template checkbox.
Click Other Actions..., and then click Change Attributes.
The Change Template Attributes dialog box appears.
Change the attributes shown.
If you select multiple templates:
The Template Name field is disabled to prevent you from assigning the same name to multiple templates.
The Status field is empty. You can choose any status to apply to the selected templates.
The description fields are disabled.
The Cost Model and Custom Field Model fields are disabled.
You cannot change the status of a deleted template or a template that is incomplete.
You cannot change the status of templates you did not create unless you are assigned a role that grants you permission to edit other users' templates.
You can only change the cost model and custom field model for unlocked templates.
Oracle recommends that you select the Update last modified date and user (template history) checkbox. However, if you often filter by the last modified date, deselect the checkbox to prevent bulk updates from changing your view.
For more information, see Change Template Attributes Dialog Box Fields
Click Save & Close.
Changes are made without opening or unlocking the templates.
What you can change depends on the number of templates selected and the status of the templates.
You maintain service providers on the Service Providers screen. The service providers on this screen are sponsor and Contract Research Organizations (CROs) and are available throughout the application, and you can assign them work to complete on a study.
To maintain service providers, your system administrator must grant you the Clinical Administrator or System Administrator role.
From the Maintain menu, select Service Providers.
The Service Providers screen appears.
In the Filter section, specify which services providers to include: sponsors, vendors, deleted providers.
On the Service Providers screen, click New.
The Create Provider screen appears.
In the Service Provider Information section, enter a service provider name, description, and select the type of service provider.
The application supports two types of service providers: sponsors and Contract Research Organizations (CROs).
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Service Provider Screen Fields.
From the Billing Rates Currency drop-down list, select the currency in which you will enter the hourly billing rates for this service provider.
From the Back-Office Billing Rate Location drop-down list, select the country in which these tasks usually occur for this provider.
The back-office billing rate location determines the default billing rates for tasks that are typically centralized or conducted at a central location.
For example, if this provider is headquartered in the USA, but conducts all of its data management, biostatistics, and medical writing tasks in India, choose India for the default Back Office Billing Rate Location.
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Note: You can override the Billing Rate Location for any specific task on the Assignment tab or in the Task Manager when you create or edit a plan. |
Click Save.
The History section appears.
If no rates have been published for this provider, the Update Billing Rates link appears.
You can enter hourly billing rates for the service provider.
Click the Update Billing Rates link.
The Create Billing Rates screen appears.
Enter hourly billing rates for the service provider. For more information on entering billing rates, see Create/Edit Billing Rates Screen.
On the Service Providers screen, select the checkbox of the service provider to edit.
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Note: You can edit service providers you added to the application, but you cannot edit the default service providers included in the application. |
Click Edit.
The Edit Provider screen appears.
Edit the service provider information as necessary.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Service Provider Screen Fields.
Click Save.
On the Edit Provider screen, you can select the Update Billing Rates link to edit billing rates for the service provider. For more information on updating billing rates, see Create/Edit Billing Rates Screen.
On the Service Providers screen, select the checkbox of the service provider to delete.
Click Delete.
On the Service Providers screen, in the Filter section, select the Deleted Providers checkbox.
Deleted services providers appear with a line through them.
Select the checkbox of the deleted service provider to restore.
Click Restore.
The application adds the service provider to the application.
On the Service Providers screen, select the checkbox of a service provider.
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Note: You can only generate a Billing Rates report for service providers you added to the application. |
Click Billing Rates Report.
The Billing Rates report appears in a separate window.
Click Close.
Resources are the roles that people who work on the study will be 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. There are two types of resources in the application:
System-defined resources—Resources the application provides. You can edit these resources. However, you cannot delete system-defined resources.
User-defined resources—Resources you add to the application. You can edit, delete, and restore these resources. If you delete a user-defined resource that is being used in a plan, that resource remains available in the plan.
You manage resources on the Resources screen. Resources can be assigned to complete work on tasks using the Task Manager. For more information about the Task Manager, see Adjust Task Effort and Labor Fees on the Labor Tab.
To maintain resources, your system administrator must grant you the Resources Administrator additional role/capability.
From the Maintain menu, select Resources.
The Resources screen appears.
You can filter the Resources screen to search for resources. For information see, Define Resource Filter Dialog Box Fields.
On the Resources screen, click New.
The Create Resource screen appears.
In the Resource Summary section, enter a resource code, name, and description.
Use the Code field to specify an alphanumeric code that represents the resource; for example, CRO1. If your company intends to use the RFP and bid management feature, you must include a code for every resource.
In the Default Billing Rates section, fill in the table. For each of the application-provided service providers, enter the hourly billing rate for the resource.
This table establishes a base rate for the ClearTrial-defined providers. You can enter or edit the U.S. hourly rate for this resource for each of the y ears you choose as the effective rate year when planning a study. Use the Maintain Billing Rates feature to provide and publish specific rates for each location.
Enter the hourly rates for each of the years chosen as the effective rate year when planning a study. For service providers you added to the application, provide specific rates for each location on the Billing Rates screen. For more information, see Billing Rates Screen Fields.
To populate the table automatically, click Auto Fill. The Auto-Populate Rates dialog box appears. Apply an hourly rate for a selected service provider or a percentage increase for each year based on the rate specified in the selected starting year. Click Ok.
Click Save.
The application creates the resource and applies the hourly rates.
To return to the Resources screen, click Close.
You can edit both system-defined and user-defined resources.
On the Resources screen, select the resource checkbox.
Click Edit.
The Edit Resource screen appears.
For user-defined resources, edit the code, name, description, and default billing rates.
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For system-defined resources, edit the code and name.
For more information about a field, click the field name.
For more information about the screen, see Resources Screen Fields.
Click Save.
To return to the Resources screen, click Close.
You cannot delete system-defined resources.
On the Resources screen, select the resource checkbox.
Click Delete.
On the Resources screen, in the Filter section, select the All Resources to display the deleted resources.
Deleted resources appear with a line through them.
Select the checkbox of the resource to restore.
Click Restore.
The application removes the line through the resource and the resource becomes active.
You define billing rates for service providers to whom you assign work on the Billing Rates screen. This screen displays currently defined billing rates and provides the ability to create, edit, delete, restore, copy, and publish billing rates. After you publish the billing rates, the application shares the rates between plans. If the rates are not ready to use, you can save a draft version of a set of billing rates. However, you cannot use draft versions in plans. You can also view the prior published rates and revert to those rates.
To work with billing rates, your system administrator must grant you the Clinical or System Administrator role.
From the Maintain menu, select Billing Rates.
The Billing Rates screen appears.
For more information about a field, click the field name.
For more information about the screen, see Billing Rates Screen Fields.
Filter the Billing Rates screen to display only those rates associated with a selected provider or a selected year. For information see, Define Resource Filter Dialog Box Fields.
On the Billing Rates screen, from the Show rates for drop-down list, select a service provider. To see rates for all providers, select Any Provider.
From the Rate Year drop-down list, select a rate year. To see rates for all years, select Any.
Billing rates matching your filter criteria appear.
Draft versions of billing rates are not available for use in plans. You must publish billing rates to use them in plans.
You can edit published billing rates and save them as drafts until you click Publish. The application continues to use the previously published billing rates until the new ones are published. You can view past billing rates by clicking Show Revision History. For more information, see Viewing the Billing Rate Revision History.
On the Billing Rates screen, click New.
The Create Billing Rates screen appears. You use this screen to create, edit, export, and publish hourly billing rates for service providers to whom you assign tasks in a study.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Billing Rates Screen.
From the When drop-down list, select a service provider doing work for a sponsor.
From the performs work for drop-down list, select the sponsor that is going to be charged these billing rates.
If your organization is a sponsor, select your organization or an affiliate from the drop-down list. These rates are used when the chosen service provider is performing work for this sponsor or affiliate.
If your organization is a service provider (for example, a CRO), select the sponsor for whom these billing rates apply or --Any Sponsor-- if these rates apply to all sponsors for which you do not load specific rates.
If you have not creates rates to charge a specific sponsor, the application uses the rates you created for --Any Sponsor--.
From the for Rate Year drop-down list, select the year for which these rates apply.
When creating a plan, the effective rate year chosen in the Provider Details dialog determines which rates are used. Rates are inflated per any inflation percentages specified.
From the Base Rate Location drop-down list, select the country or region the rates you enter in the Base Rate column represent.
The Currency field displays the currency in which the billing rates are expressed. The service provider selected from the drop-down list determines the currency.
By default, the application derives the rates of all other locations using the values in the RATE VARIANCE % row. You can edit any variance or override any specific rate value.
For each Resource, for each location column, enter the hourly billing rate.
Each resource row represents a job title or type of employee that performs work on a study. For each resource, the application multiples the hourly rate supplied by the number of hours calculated to be necessary for employees of this type to complete the work.
The application uses generic job titles. For a description of a resource, click the resource name. You can view and download a list of the resource descriptions from the Help topic associated with the Create Billing Rates screen. User-defined resources are included.
Note the column whose Rate Variance % value is 100%. That is the location serving as the base rate. The rates for all other locations are derived as a percentage of the variance value of the base rate. You can change any variance or override any specific rate value.
Click Save.
To publish the rates, click Publish.
To view or save the rates as a Microsoft Excel spreadsheet, click the Export rates to Excel link.
To define billing rates for another service provider, select the service provider from the When drop-down list and repeat this procedure.
On the Billing Rates screen, select the checkbox of billing rates with a Draft status.
Click Publish.
The Confirm Publish Rates dialog box appears.
Click Publish.
The rates are immediately effective and available. Any unlocked plans that do not have frozen rates will reflect these changes.
You can edit and save rates in a draft state as many times as necessary prior to publishing them. You can also edit published rates and save them as a new draft that does not replace the published rates. When you are ready, you can publish that draft and replace the currently published rates.
On the Billing Rates screen, select the checkbox of the billing rates to edit.
Click Edit.
The Edit Billing Rates screen appears.
Edit hourly billing rates as necessary.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Billing Rates Screen.
Click Save.
On the Billing Rates screen, select the checkbox of the billing rates to delete.
Click Delete.
The application does not permanently delete the service provider billing rates. The deleted service provider appears with a line through it. You can restore the deleted rates.
On the Billing Rates screen, in the Filter section, select the Include Deleted Rates checkbox.
Service providers with deleted billing rates appear with a line through them.
Select the checkbox of a deleted billing rate.
Click Restore.
On the Billing Rates screen, select the checkbox of the billing rates to copy.
Click Copy.
The Copy Billing Rates dialog box appears.
For more information about a field, click the field name.
For more information about the screen, see Copy Billing Rates Dialog Box Fields.
From the Copy from drop-down list, select the version of billing rates to copy. If there is only one option, this field is read-only.
Apply a percent adjustment (positive or negative) to reflect inflation or other negotiated changes to the fees charged by selecting the checkbox and entering a percentage.
This is useful for creating rates for a number of years for the same vendor when you expect the rates to increase or decrease by a certain percentage each year.
Click Ok.
The Edit Billing Rates screen appears.
Edit the hourly billing rates as necessary.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Billing Rates Screen.
Click Save.
On the Billing Rates screen, select the checkbox of the billing rates.
Click Show Revision History.
The Show Revision History dialog box appears.
To view the billing rates for a previously published set of billing rates, click the Show Rates link.
The billing rates appear in a separate window.
or
Click the Open as Draft link to open the Edit Billing Rates screen to edit the billing rates, save them as a draft, or publish them.
Click Close.
On the Billing Rates screen, select the checkbox of the billing rates.
Click Show Revision History.
The Show Revision History dialog box appears.
Click the Show Rates link to view the billing rates for a previously published set of billing rates.
The billing rates appear in a separate window.
Click Close.
You define inflation profiles for service providers to whom you assign work on the Inflation Profiles screen. After you publish the inflation profile, the application shares the rates between plans. Inflation profiles correspond to a set of billing rates for the specified rate year. The application suggests rate variances by location so you can set inflation rates for a base location and the application translates those rates to other locations based on economic forecasts by region.
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Note: To use your predicted inflation rates only for specific locations, overwrite the default ClearTrial values with your values for those specific locations. Leave the ClearTrial defaults in the remaining locations in the event one of those remaining locations is later included in a plan. |
Many sponsors and CROs negotiate inflation rates, along with billing rates, as part of a Master Services Agreement or a Statement of Work. You can create custom inflation profiles by provider to match these negotiated rates. Each time you create a plan, you can then apply the profiles to create a more accurate estimate of the costs you expect to see in the provider bids.
To work with inflation profiles, your system administrator must grant you the Clinical or System Administrator role.
From the Maintain menu, select Inflation Profiles.
The Inflation Profiles screen appears.
For more information about a field, click the field name.
For more information about the screen, see Inflation Profiles Screen Fields.
Filter the Inflation Profiles screen to display only those inflation profiles associated with a selected provider or a selected year. For information see, Inflation Profiles Screen Fields.
From the Show Profile for drop-down list, select a vendor. To see inflation profiles for all vendors, select Any Provider.
From the for Rate Year drop-down list, select a rate year. To see inflation profiles for all years, select Any.
Inflation profiles matching your filter criteria appear.
Draft versions of inflation profiles are not available for use in plans. You must publish inflation profiles to use them in plans.
You can edit published inflation profiles and save them as drafts until you click Publish. The application continues to use the previously published inflation profiles until the new ones are published. You can view past inflation profiles and revert to these by clicking Show Revision History. For more information, see Viewing the Inflation Profiles Revision History.
On the Inflation Profiles screen, click New.
The New Inflation Profile dialog box appears.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Inflation Profile Screen Fields.
From the When drop-down list, select the service provider for which this inflation profile applies.
From the performs work for drop-down list, select the sponsor that will be charged these rates.
If your organization is a sponsor, select your organization or an affiliate from the drop-down list.
If your organization is a service provider, select the sponsor for whom this inflation profile applies.
From the for Rate Year drop-down list, select the rate year to which to apply this inflation profile.
When creating a plan, the effective rate year chosen in the Provider Details dialog determines which billing rates are used. Rates are inflated per any inflation percentages specified.
A rate year is defined as January - December for the relevant year.
The Rate Year in effect determines the correct Billing Rate table and which Inflation Profile is used in that plan.
If there is no Inflation Profile for the sponsor/provider combination and Rate Year, the application issues an alert and the inflate rate defaults to 0% for all years in the plan.
Click Ok.
The Create Inflation Profile screen appears.
All the countries supported for the ClearTrial application are shown and the fields prepopulated with any already defined rates. Note that your selections from the New Inflation Profile dialog box appear at the top of the table.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Inflation Profile Screen Fields.
From the Base Rate Location drop-down list, select the country or region for which the base rate applies.
By default, the application derives the rates of all other locations using the values in the RATE VARIANCE % row. You can edit any variance or override any specific rate value.
You can change any variance or override any specific percentage.
If you want to use the same inflation rate values in all locations, enter the values once in the Base Rate column and change the Rate Variances by location to 100% so that the application applies the base rate values by year to every location.
For each Year, for each location column, enter the inflation rate as a percentage.
The default specification includes five years, because most trials planned are five years. You can add years by clicking Add Year. You can specify inflation rates for up to 30 years.
To exclude an inflation calculation, enter a zero.
You can include a different rate for every year of the trial and relative to each location.
Click Save.
The ClearTrial application saves the inflation profile as a draft. To publish the draft, click Publish.
On the Inflation Profiles screen, select the checkbox of an inflation profile with a Draft status.
Click Publish.
The Confirm Publish Profile dialog box appears.
Click Publish.
The inflation rates are immediately effective and available. Any unlocked plans that do not have frozen inflation rates will reflect these changes.
You can edit and save inflation profiles in a draft state as many times as necessary prior to publishing them. You can also edit published inflation profiles and save them as a new draft that does not replace the published inflation profile. When you are ready, you can publish that draft and replace the currently published inflation profile.
On the Inflation Profiles screen, select the checkbox of the inflation profile to edit.
Click Edit.
The Edit Inflation Profile screen appears.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Inflation Profile Screen Fields.
Edit the base rate and percentages applied to selected regions and countries for the years shown as necessary.
Click Save.
If your profile matches an existing profile, the application asks you to confirm that you want to overwrite the existing values rather than create a new profile.
On the Inflation Profiles screen, select the checkbox of the inflation profile to delete.
Click Delete.
The application does not permanently delete the inflation profile. The deleted inflation profile appears with a line through it. You can restore the deleted inflation profile.
On the Inflation Profiles screen, in the Filter section, select the Include Deleted Profile checkbox.
Deleted inflation profiles appear with a line through them.
Select the checkbox of a deleted inflation profile.
Click Restore.
You can copy a draft, published, or prior published inflation profile.
On the Inflation Profiles screen, select the checkbox of the inflation profile to copy.
Click Copy.
The Copy Inflation Profile dialog box appears.
For more information about a field, click the field name.
For more information about the screen, see Copy Inflation Profile Dialog Box Fields.
Enter the details for the copy of the inflation profile.
From the When drop-down list, select a vendor.
From the performs work for drop-down list, select the sponsor for whom the inflation profile applies.
From the for Rate Year drop-down list, select the billing rate year to use.
From the Copy from drop-down list, select the version of the inflation profile to copy. If there is only one option, this field is read-only.
Click Ok.
The Create Inflation Profile screen appears. All the countries supported for the ClearTrial application are shown and the fields prepopulated with any already defined rates. Note that your selections from the New Inflation Profile dialog box appear at the top of the table.
Click Save.
The application saves the changes to the copy of the inflation rate profile and adds the draft to the Inflation Profiles screen.
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Note: Both the source and the copied inflation profiles will be identical except with respect to the years, which will start with the new effective rate year +1. The inflation rate values will be the same with respect to the years' offset within that profile as within the source. |
On the Inflation Profiles screen, select the checkbox of the inflation profile.
Click Show Revision History.
The Show Revision History dialog box appears displaying the profile status, last modified date, and user who last modified the profile.
To view the profile, click the Show Profile link.
The inflation profile appears in a separate window.
or
To edit a published inflation profile, click the Open as Draft link to open the Edit Inflation Profile screen.
Edit the profile as necessary.
Click Save.
Click Close.
You maintain departments and functional areas and map them to labor and costs on the Departments screen. To work with departments, your system administrator must grant you the Departments/GL Codes Administrator additional role.
For more information, see Departments Screen Fields.
From the Maintain menu, select Departments/Functional Areas.
The Departments screen appears.
In the Filter section, specify whether to include all departments, active departments only, or departments matching a selected filter.
To create or modify a filter, click the Modify link.
The Define Department Filter dialog box appears.
For more information, see Define Department Filter Dialog Box Fields.
On the Departments screen, click New.
The Create Department screen appears.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Department Screen Fields.
In the Code field, enter a department code.
This alphanumeric code represents the department and appears throughout the application. For example, the code for the Biostatistics department might be ST.
In the Name field, enter a department name.
The department name appears throughout the application. Two departments cannot have the same name.
In the Description field, enter a description of the department.
Click Save.
To return to the Department screen, click Close.
On the Departments screen, select a department checkbox.
Click Edit.
The Edit Department screen appears.
Edit the department information as necessary.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Department Screen Fields.
Click Save.
To return to the Department screen, click Close.
On the Departments screen, select the checkbox of a department to delete.
Click Delete.
The application does not permanently delete the department. The deleted department appears with a line through it. You can restore the deleted department
On the Departments screen, in the Filter section, select All Departments .
Deleted departments appear with a line through them.
Select the checkbox of a deleted department.
Click Restore.
Use this feature to map labor to departments by resource. You can map departments to internal and outsourced providers for each resource. You can also provide a default department for internal and outsourced mappings by selecting departments in the Default row.
For more information about a field, click the field name.
For more information about the screen, see Edit Department Mapping Screen Fields.
On the Departments screen, click Map Labor and Costs.
The Edit Department Mapping screen appears. There are four department mapping tabs:
Labor (Late stage)—Map labor to departments for late-stage studies.
Labor (Phase 1)—Map labor to departments for Phase I studies.
Costs (Late stage)—Map costs to departments for late-stage studies.
Costs (Phase 1)—Map costs to departments for Phase I studies.
For each department mapping tab, select the mapping mode by clickingthe Change link in the upper right corner.
The Change Mode dialog box appears.
Select a mapping mode by clicking the radio button.
There are four mapping modes:
Resource—Map labor to departments by resource. You can map departments to internal and outsourced providers for each ClearTrial-defined and user-defined resource.
Location—Map labor to departments by location. You can map departments to internal and outsourced providers for each location.
Task—Map labor to departments by task. You can map departments to internal and outsourced providers for each task. You can provide a default department for internal and outsourced providers for all tasks by setting departments in the Default row, or for all tasks within a task group by selecting departments in a task group row.
Rule (Advanced Mode)—Map labor to departments by your own criteria. For more information, see Adding a Department Mapping Rule.
Click Ok.
The Edit Department Mapping screen for the selected mode appears.
For each tab, do the following:
In the Default row, select default department mappings for internal and outsourced tasks from the drop-down lists.
In the Internal column, select a department mapping for each resource, location, or task.
In the Outsourced column, select a department mapping for each resource, location, or task.
Click Save.
To restore the labor mappings to the default application configuration, click Restore ClearTrial Defaults. The application discards any labor mappings you created.
On the Departments screen, click Map Labor and Costs.
The Edit Department Mapping screen appears.
Edit department mappings as necessary.
For more information about a field, click the field name.
For more information about the screen, see Edit Department Mapping Screen Fields.
Click Save.
On the Departments screen, click Map Labor and Costs.
The Edit Department Mapping screen appears.
Select a department mapping tab and click the Change link in the upper right corner.
The Change Mode dialog box appears.
Click the Rule (Advanced Mode) radio button.
Click Ok.
The Edit Department Mapping screen appears. There are tabs for Labor or Costs for Phase 1 and Late Phase.
Click Add Rule.
The Create Department Mapping Rule dialog box appears.
For more information about a field, click the field name.
For more information about the screen, see Create Department Mapping Rule Dialog Box
Do the following. Which choices you have are determined by your choice in step 4.
From the Department drop-down list, select the department to be assigned when this rule is applied.
On the Providers tab, select providers to be matched according to this rule.
Select Any Provider to include both Internal and outsourced service providers. Select the Internal and Outsource checkboxes to include all the service providers in that group.
On the Locations tab, select locations to be matched according to this rule.
Selecting the Any Location checkbox includes all locations.
On the Tasks tab, select the checkboxes of tasks to be matched according to this rule.
Selecting the Any Task checkbox includes all task groups and tasks.
On the Costs tab, select the checkboxes of costs to be matched according to this rule.
Selecting the Any Cost checkbox includes all costs.
On the Resources tab, select resources to be matched according to this rule.
Selecting the Any Resource checkbox includes all resources.
Click Ok.
The rule is added to the department mapping tab.
Click Save.
You maintain General Ledger (GL) codes and map them to labor and costs on the GL Codes screen. To work with GL codes, your system administrator must grant you the Departments/GL Codes Administrator additional role. You can create, edit, delete, and restore GL codes.
For more information about a field, click the field name.
For more information about the screen, see GL Codes Screen Fields.
From the Maintain menu, select GL Codes.
The GL Codes screen appears.
You can filter the GL Codes screen to include all GL codes, active codes only, or specific criteria you have defined.
For more information, see Define GL Code Filter Dialog Box Fields.
You can edit ClearTrial-defined GL codes and user-defined GL codes.
On the GL Codes screen, click New.
The Create GL Code screen appears.
In the Code field, enter a code.
The code is an alphanumeric code that represents the GL code and appears throughout the application.
In the Name field, enter a name for the GL code.
The GL code name appears throughout the application. Two GL codes cannot have the same name.
In the Description field, enter a description of the GL code.
Click Save.
To return to the GL Code screen, click Close.
You can edit both ClearTrial-defined GL codes and user-defined codes.
On the GL Codes screen, select the checkbox of a GL code you want to edit.
Click Edit.
The Edit GL Code screen appears.
Edit the GL code information as necessary.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit GL Code Screen Fields.
Click Save.
To return to the GL Code screen, click Close.
On the GL Codes screen, select the checkbox of a GL code to delete.
Click Delete.
Deleted GL codes appear with a line through them.
On the GL Codes screen, in the Filter section, select All GL Codes.
Deleted GL codes appear with a line through them.
Select the checkbox of a deleted GL code.
Click Restore.
You can map labor categories to GL codes by resource. For each resource you can map GL codes to internal and outsourced providers. You can also enter a default GL code for internal and outsourced providers for all resources by setting GL codes in the Default row.
For more information about a field, click the field name.
For more information about the screen, see Edit GL Code Mapping Screen Fields.
On the GL Codes screen, click Map Labor and Costs.
The Edit GL Code Mapping screen appears. There are four GL code mapping tabs:
Labor (Late stage)—Map labor to GL codes for late-stage studies.
Labor (Phase 1)—Map labor to GL codes for Phase I studies.
Costs (Late stage)—Map costs to GL codes for late-stage studies.
Costs (Phase 1)—Map costs to GL codes for Phase I studies.
For each GL code mapping tab, select the mapping mode by clicking the Change link in the upper right corner.
The Change Mode dialog box appears.
Select a mapping mode by clicking the radio button.
There are four mapping modes:
Resource—Map labor to GL codes by resource. You can map GL codes to internal and outsourced providers for each ClearTrial-defined and user-defined resource.
Location—Map labor to GL codes by location. You can map GL codes to internal and outsourced providers for each location.
Task—Map labor to GL codes by task. You can map GL codes to internal and outsourced providers for each task. You can provide a default GL code for internal and outsourced providers for all tasks by selecting GL codes in the Default row, or for all tasks within a task group by selecting GL codes in a task group row.
Rule (Advanced Mode)—Map labor to GL codes by your own criteria. For more information, see Adding a GL Code Mapping Rule.
Click Ok.
The Edit GL Code Mapping screen for the selected mode appears.
For each tab, do the following:
In the Default row, select default GL code mappings for internal and outsourced tasks from the drop-down lists.
In the Internal column, select a GL code mapping for each resource, location, or task.
In the Outsourced column, select a GL code mapping for each resource, location, or task.
Click Save.
On the GL Codes screen, click Map Labor and Costs.
The Edit GL Code Mapping screen appears.
Edit GL code mappings as necessary.
For more information about a field, click the field name.
For more information about the screen, see Edit GL Code Mapping Screen Fields.
Click Save.
On the GL Codes screen, click Map Labor and Costs.
The Edit GL Code Mapping screen appears.
Select a GL code mapping tab and click the Change link in the upper right corner.
The Change Mode dialog box appears.
Click the Rule (Advanced Mode) radio button.
Click Ok.
The Edit GL Codes Mapping screen appears.
Click Add Rule.
The Create GL Code Mapping Rule dialog box appears.
For more information about a field, click the field name.
For more information about the screen, see Create GL Code Mapping Rule Dialog Box.
On the Create GL Code Mapping Rule dialog box, do the following. Which choices you have are determined by your choice in step 4.
From the GL Code drop-down list, select the GL code to be assigned when this rule is applied.
On the Providers tab, select providers to be matched according to this rule.
Selecting the Internal and Outsource checkboxes includes all the service providers in that group.
On the Locations tab, select locations to be matched according to this rule.
Selecting the Any Location checkbox includes all locations.
On the Tasks tab, select the checkboxes of tasks to be matched according to this rule.
Selecting the Any Task checkbox includes all task groups and tasks.
On the Resources tab, select resources to be matched according to this rule.
Selecting the Any Resource checkbox includes all resources.
Click Ok.
The rule is added to the GL code mapping tab.
Click Save.
You maintain exchange rates on the Exchange Rate Tables screen. An exchange rate table allows you to create and define your organization's standardized rates for each currency to be used in your plans.
To work with exchange rate tables, your system administrator must grant you the Exchange Rates Administrator role.
Exchange rate tables you create on this screen can be shared by multiple plans. If you designate one of the exchange rate tables as the default table, the application automatically applies that exchange rate table to new plans.
For more information about a field, click the field name.
For more information about the screen, see Exchange Rate Tables Screen Fields.
You can save a draft version of the exchange rate table if the values are not ready for use. Draft versions are not available for use in plans. Exchange rate tables must be published to be used in plans. You can edit previously published exchange rate tables, save the table as a draft, and later publish it. The application continues to use the previously published values until the new draft is published. When you update an exchange rate table, all plans using the table automatically update with the new conversion rates. You apply a published exchange rate table to a plan on the Overview tab.
From the Maintain menu, select Exchange Rates.
The Exchange Rate Tables screen appears.
In the Filter section, specify whether to use all exchange rate tables, actives tables only, or tables matching a selected filter.
To create or modify a filter, click the Modify link.
The Define Exchange Rate Table Filter dialog box appears.
For more information, see Define Exchange Rate Table Filter Dialog Box Fields.
On the Exchange Rate Tables screen, click New.
The Create Exchange Rate Table screen appears.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Exchange Rate Table Screen Fields.
In the Details section, in the Name field, enter a name for the exchange rate table.
This name appears throughout the application.
In the Description field, enter a short description to identify this exchange rate table.
In the Currency Exchange Rates section, in the Use rates as of field, enter or select a date from the Calendar icon and click Apply to populate the currency exchange rates with ClearTrial default values from a certain date.
In the Currency Exchange Rate, fields, enter what one unit of the currency equals in each of the other locations.
To save the exchange rate table as a draft, click Save Draft.
or
To make the exchange rate table available for use in plans, click Publish.
To return to the Exchange Rate Tables screen, click Close.
On the Exchange Rate Tables screen, select the checkbox of the table to edit.
Click Edit.
The Edit Exchange Rate Table screen appears.
Edit the exchange rates as necessary.
For more information about a field, click the field name.
For more information about the screen, see Create/Edit Exchange Rate Table Screen Fields.
To save the exchange rate table as a draft, click Save Draft.
or
To make the exchange rate table available for use in plans, click Publish.
Clicking Publish replaces values in any plans currently using the exchange rate table. The application automatically updates all plans using the exchange rate table with the new conversion rates.
To return to the Exchange Rate Tables screen, click Close.
On the Exchange Rate Tables screen, select the checkbox of the table to delete.
Click Delete.
Deleted exchange rate tables appear with a line through them.
On the Exchange Rate Tables screen, click the All Exchange Rate Tables radio button.
Deleted exchange rate tables appear with a line through them.
Select the checkbox of a deleted exchange rate table.
Click Restore.
You can group reporting regions for studies based on your global organizational structure and accounting practices with the Edit Reporting Regions screen.
You then map countries to reporting regions. Mapping allows you to view the budget by location with the Monthly Budget by Reporting Region report, available from the Reports tab.
To work with reporting regions, your system administrator must grant you the Reporting Regions Administrator role.
For more information about a field, click the field name.
For more information about the screen, see Reporting Regions Screens and Dialog Boxes.
From the Maintain menu, select Reporting Regions.
The Edit Reporting Regions screen appears showing each reporting region defined and the number of countries mapped.
On the Edit Reporting Regions screen, click New Reporting Region. If this is the first reporting region being added, enter a name for the new reporting region and click New Reporting Region.
A blank entry appears in the Reporting Region Name column.
Enter a reporting region name.
Click Save.
Continue adding reporting regions by clicking New Reporting Region, entering the reporting region name, and clicking Save.
On the Edit Reporting Regions screen, in the Reporting Region Name column, click the reporting region name or the Pencil icon.
The reporting region name becomes editable.
Edit the reporting region name.
Click Save.
To delete a reporting region, click the associated Trash Can icon.
When reporting regions are deleted, the application removes the country mappings.
Map countries to the reporting regions you defined to view the Monthly Budget by Reporting Region report for a plan.
On the Edit Reporting Regions screen, click Map Countries to Reporting Regions.
The Map Countries to Reporting Regions dialog box appears.
For each country, from the Reporting Region drop-down list, select a reporting region.
To save your changes and keep the dialog box open, click Save.
or
To save your changes and return to the Edit Reporting Regions screen, click Save and Close.
Select a plan and on the Edit Plan screen, click the Reports tab.
A list of available study reports appear.
In the Costs section, click Monthly Budget by Reporting Region.
If you have locations in the plan that are mapped to reporting regions, the Monthly Budget By Reporting Region report appears and shows the study costs by month by reporting region over the duration of the study.
Click Close.
When items are deleted, they are not actually removed from the application database. Instead the application marks them as deleted and stamps them with a date indicating when they were marked as deleted. This allows restoration of items that were deleted in error.
The application, however, permanent removes, or purges, deleted items regularly to conserve data storage space and to insure maximum application responsiveness. Purging takes place automatically at night to permanently remove items that have been deleted more than 30 days prior to the current date.
If you are a system administrator, however, you can override the 30-day deletion setting or initiate immediate purging of deleted items.
From the Maintain menu, select Purge Deleted items.
The Purge Deleted screen appears.
Select the checkboxes of the item types to be purged.
In the deleted at least n days ago field, specify the number of days since an item of the selected type was deleted and should now be purged.
To purge all deleted items of the selected type, enter 0.
Click Purge Selected Items.
The application finds all selected items that were deleted within the specified number of days and purges them.
The Custom Field Models screen displays a DRAFT model and any published custom field models. A published custom field model represents a set of custom fields that can be used in plans by other users. Any published model will have a version number assigned. You can open or change the description on published models, but the custom fields in a published model cannot be modified.
The DRAFT model is considered the working copy and is the only version where changes can be made to custom fields. You can perform the following actions on the DRAFT model: open, check out, check in, cancel checkout, and publish. The DRAFT model is not available to use in plans unless you have the Custom Fields Designer permission.
Checkout—Reserves the DRAFT model so that changes can be made to it. When the DRAFT is checked out by one custom field designer, other custom field designers are not able to modify it; however, the other custom field designers can still view it in read-only mode.
Check-in—Commits any changes made during a checkout session. This also makes the DRAFT model available to be checked out and modified by another custom field designer. Changes that have been made during a checkout session, but have not yet been checked-in, cannot be viewed or modified by other custom field designers.
Publish—Creates a new Custom Field Model version that consists of the custom fields that existed in the DRAFT model at the time of publishing. Publishing also releases the new Custom Field Model version for use in plans.
From the Maintain menu, select Custom Fields.
The Custom Field Models screen appears.
If a displayed custom field model has been published, the Version field contains a numeric value and the Published Date and Published By columns are populated.
If the DRAFT custom field model is checked out for editing, the Checkout Date and Checkout By columns are populated.
For more information about a button or column name, click the Help menu and select With the Current Screen.
For more information about the screen, see Custom Field Models Screen Fields.
You can open a custom field model to display the custom fields that exist within the model and view custom field definitions, display criteria, and designer notes.
On the Custom Field Models screen, select the radio button associated with a custom field model and click Open.
The Custom Fields screen for the selected custom field model appears and displays all the custom fields that exist in the selected model. The information displayed is read only and cannot be modified on this screen.
To view the field definitions, display criteria, and design notes of a custom field, select the checkbox for a custom field and click View.
The View Custom Field screen appears. The information displayed is read-only and cannot be modified in view mode.
To return to the Custom Fields screen, click Close.
Once on the Custom Fields screen, to return to the Custom Field Models screen, click Return to Custom Field Models.
You can check out the DRAFT model to add new or modify existing custom fields.
From the Maintain menu, select Custom Fields.
The Custom Field Models screen appears.
Select the radio button associated with the DRAFT custom field model.
Click Checkout.
The Custom Fields screen for the DRAFT custom field model appears.
To return to the Custom Field Models screen, click the Return to Custom Field Models link.
If you have finished making changes to the DRAFT model, you can check in your updates to make them available to other custom field designers.
On the Custom Field Models screen, select the radio button associated with the DRAFT custom field model.
The Custom Field Models screen appears.
Click Check-In.
The Checkout Date and Checkout By columns are blanked out.
Or:
On the Custom Fields screen for the DRAFT custom field model, click Check-in.
Any changes made to the DRAFT custom field model are saved and you are returned to the Custom Field Models screen.
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Note: Once you have checked in the DRAFT model, if you decide you no longer want the changes that were just checked in, you must check out the DRAFT and delete or manually update the DRAFT custom fields and related field definitions back to the desired state. |
If you have the DRAFT model checked out and decide you no longer need any of changes you made in that checkout session, you can cancel that checkout session. Cancelling a checkout removes any changes you made during that checkout session and restores the DRAFT model to the last checked in state.
On the Custom Field Models screen, select the radio button associated with the DRAFT custom field model.
The Custom Field Models screen appears.
Click Cancel Checkout.
Or
On the Custom Fields screen for the DRAFT custom field model, click Cancel.
All changes made in the last checkout session are removed and the custom fields in the DRAFT custom field model are restored to the last checked in state.
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Note: You are not able to cancel another custom field designer's checkout session; you can only cancel your own checkout sessions. If the custom field designer who has the DRAFT checked out is unavailable for an extended period of time, you can contact your system administrator to cancel the checkout. Any change that was not checked in will be lost. |
You can create new custom fields within the DRAFT custom field model.
From the Maintain menu, select Custom Fields.
The Custom Field Models screen appears.
Select the radio button associated with the DRAFT custom field model, and click Checkout.
Or:
If the DRAFT custom field model is already checked out, click Open.
The Custom Fields screen for the checked out DRAFT custom field model appears.
Click New.
The Create Custom Field screen appears.
Define the custom field by completing the Field Definition, Display Criteria, and Designer Notes sections.
For more information about a field, click the text box in which you enter the information.
For more information about the screen, click the field name to see a help topic.
For field descriptions see View/Create/Edit Custom Field Screen Field Descriptions.
Click Save.
To return to the Custom Fields screen, click Close.
You can change the field definitions, display criteria, and designer notes for existing custom fields within the DRAFT custom field model.
From the Maintain menu, select Custom Fields.
The Custom Field Models screen appears.
Select the radio button associated with the DRAFT custom field model, and click Checkout.
Or:
If the DRAFT custom field model is already checked out, click Open.
The Custom Fields screen for the DRAFT custom field model appears.
Select the checkbox for the custom field you want to edit, and click Edit.
The Edit Custom Field screen appears.
Modify the custom field values in the Field Definition, Display Criteria, and Designer Notes sections.
For more information about a field, click the text box in which you enter the information.
For more information about the screen, click the field name to see a help topic.
For field descriptions see View/Create/Edit Custom Field Screen Field Descriptions.
Click Save.
To return to the Custom Fields screen, click Close.
You can delete custom fields from the DRAFT custom field model that are no longer required for your standard operating procedures.
From the Maintain menu, select Custom Fields.
The Custom Field Models screen appears.
Select the radio button associated with the DRAFT custom field model, and click Checkout.
Or:
If the DRAFT custom field model is already checked out, click Open.
The Custom Fields screen for the DRAFT custom field model appears.
Select the checkbox for the custom field you want to delete, and click Delete.
Deleted custom fields are preserved and are not purged by the application.
You can restore custom fields to the DRAFT custom field model that were deleted in the past.
From the Maintain menu, select Custom Fields.
The Custom Field Models screen appears.
Select the radio button associated with the DRAFT custom field model, and click Checkout.
Or:
If the DRAFT custom field model is already checked out, click Open.
The Custom Fields screen for the DRAFT custom field model appears.
In the Filter section, select All Custom Fields.
Deleted custom fields appear with a line through them.
Select the checkbox of a deleted custom field, and click Restore.
The application removes the strike-through line from the restored field.
You can create a new custom field based on a copy of another custom field.
From the Maintain menu, select Custom Fields.
The Custom Field Models screen appears.
Select the radio button associated with the DRAFT custom field model, and click Checkout.
Or:
If the DRAFT custom field model is already checked out, click Open.
The Custom Fields screen for the DRAFT custom field model appears.
Select the checkbox for the custom field you want to copy, and click Copy.
The Edit Custom Field screen appears that is a copy of the selected custom field.
Modify the custom field values in the Field Definition, Display Criteria, and Designer Notes sections. You must change the Name, Label, and Unit of Measure (Singular) fields.
For more information about a field, click the text box in which you enter the information.
For more information about the screen, click the field name to see a help topic.
For field descriptions see View/Create/Edit Custom Field Screen Field Descriptions.
Click Save.
To return to the Custom Fields screen, click Close.
The copied field appears on the Custom Fields screen.
Once you have made your changes to the DRAFT custom field model and are ready to make it available to be used in plans, you can publish the DRAFT.
From the Maintain menu, select Custom Fields.
The Custom Field Models screen appears.
Select the radio button associated with the DRAFT custom field model, and click Publish.
Or:
On the Custom Fields screen for the DRAFT custom field model, click B.
The Publish Custom Fields dialog box appears.
In the Description field, you must type a short description for the new custom field model.
Click Publish.
The Custom Field Models page appears.
A new published custom field model is created that consists of the custom fields that existed in the DRAFT model at the time of publishing. The new model is assigned a version number.
If the DRAFT custom field model was in a checked-out state at the time you clicked Publish, all changes made during that checkout session are saved and incorporated into the new published custom field model. The DRAFT custom field model is returned to a checked in state.
You can now use the custom fields in your plans.
You can change the description on any published custom field model.
On the Custom Field Models screen, select the radio button of the published custom field model whose description you want to change.
Click Change Description.
The Change Description dialog box appears.
In the Description field, change the short description of the custom field model.
Click Save & Close.
The description on the Custom Field Models screen changes.
If you have the custom field designer permission, you can assign a plan to the DRAFT model to review the impacts before you publish it.For more information on assigning a custom field model to a plan, see Change Attributes.Only those updates made to the DRAFT custom field model that have been checked in can be seen in plans. ClearTrial recommends that the DRAFT model is not assigned to live plans to minimize any disruptions to other users who might be using those plans. You should create a copy of the live plan and then apply the DRAFT custom field model to the copy.
