Permissions: Users must have the RACT Configure privilege to configure the RACT.

The Configuration page has eight sections that are used to configure the RACT at the URL level. Each area is set up initially and can be added to and edited.

• Questions Library: All the Risk Assessment Questions that have been defined in RACT and allows users to review questions suggested during assessments, as well as add, deprecate, or edit questions. The list of predefined questions is from the TransCelerate RACT. Additional questions can be added to customize the RACT for a specific study.
• Question Exclusions: A list of questions (from the Questions Library) that should be excluded for studies that match a predetermined study property. The exclusions can be defined by configuring what questions are excluded for each study property or by configuring what properties are excluded for each question.
• Categories: The categories used in the TransCelerate RACT are predefined in the system. The list of categories can be added to or edited, and questions are assigned to a category. 
• Functional Plans: The functional plans used with the TransCelerate RACT are predefined in the system, and the list of functional plans can be added to or edited.
• Response Strategies: No response strategies are defined in the system initially. The list of response strategies can be added to or edited.
• Risk Statement Configuration: The list of fields in the New / Edit Risk Statement window and the columns that display in the Risk Statements list. Fields can be configured to be visible or hidden, and a tooltip can be added. Custom fields may also be added and managed.
• Global Critical Data: No global critical data are defined in the system initially. The list can be added to and edited. New studies that are RACT enabled are automatically populated with items listed in Global Critical Data at the time of study creation.
• Global Critical Process:  No global critical processes are defined in the system initially. The list can be added to and edited. New studies that are RACT enabled are automatically populated with items listed in Global Critical Processes at the time of study creation. 

Note: Updates to global level libraries do not update existing studies' Critical Data or Critical Processes.

Access each section by clicking on the section name in the left navigation.

Listing Functionality

Most columns in the lists can be sorted, filtered, resized, and fixed. Click a column header to sort or filter; right-click a column header to fix it to the left or right.

To filter, click a column header, select Filter, enter your criteria, and click Filter Rows. Filtered columns display a solid filter icon in the header; the Filters icon (top right) will also be solid. Use the Filters icon to clear all filters, or remove them individually. 

Click the back arrow at any time to return to the RACT Landing Page.

Questions Library

The Questions Library contains all the questions that have been defined in RACT and allows users to review questions suggested during assessments. The list of pre-populated questions is from the TransCelerate RACT. Questions can be added, edited, new versions created, and deprecated. The current version of a question is used when creating or adding questions to a study assessment.

Important: The currently published version of a question is used when creating a study assessment. When an older version of a question is used in an approved study assessment, the user has the option to upgrade the question to the latest published version while editing the study assessment. This is not done automatically.

Columns include Sequence, Category, Question Name, Version, Status, Exclusion Tags, and Considerations.

Toolbar options (except for the Add icon) are grayed out until a row is selected. Grayed out icons indicate they are not active. 

• Add: Click to Create a New Risk Assessment Question
• Edit: Click to Edit a Risk Assessment Question
• Change Status: Click to change the status of the Risk Assessment Question, options include New Draft Version, Publish, or Deprecate
• Details: Click to open the Question Details at the right of the window. 
• Reorder Questions: Click to open the Reorder Question window.
• Filters: A solid filter Indicates filters are set in the columns. Click to clear filters.

Add a New Risk Assessment Question

1. Click the Add icon. The Create New Risk Question window opens.
2. Enter the Question Name (required).
3. Select the Category from the drop-down (required).
4. Enter the Question Abbreviation (required).
5. Enter Considerations (optional).
6. Click Save and Publish or Save as Draft. A confirmation dialogue box briefly displays. The status of the question displays as Draft or Published based on your selection.

Edit a Risk Assessment Question

1. From the listing, click a row and select the Edit icon, or right-click a row and select Edit or from the Question Details, click the Edit icon. The Edit Risk Question window opens.
2. Update the fields.
3. Enter Version Notes (optional).
4. Click Save and Publish or Save as Draft. A confirmation dialogue box briefly displays. The status of the question displays as Draft or Published based on your selection.

Change the Status of a Question

Question statuses include New Draft Version, Publish, or Deprecate. Options depend on the status of the question.

1. Select question(s) by checking the box(es) at the left and click the Change Status icon, or right-click a row and select Change Status.
2. Select the Status: New Draft Version, Publish, or Deprecate.

View Question Details

1. Highlight a row and click the Details icon, double-click a row, or right-click a row and select Details.
2. The Question Details window opens at the right of the window. From the Question Details you can edit the question, see any exclusions, or go to Question Exclusions.
3. To close the Question Details window, click the X.

Reorder Questions

1. Select a question by checking the box at the left
2. Click the Reorder Questions icon, or right-click a question and select Reorder Questions. The Reorder Question window opens displaying all questions in the category of the selected question.
3. Hover your mouse over the 6 dots and drag the questions to the desired order.
4. Click Save. Or click Cancel to cancel your actions.

Tip: If questions from multiple categories are selected, the Reorder Questions icon remains grayed out. Select from one category at a time.

Question Exclusions

Question Exclusions provides a list of questions (from the Questions Library) that should be excluded for studies that match a predetermined study property. The Exclusions can be defined by configuring what questions are excluded for each study property or by configuring what properties are excluded for each question.

Columns include Study Attribute, Value, and Excluded Question.

Toolbar options (except for the Configure icon) are grayed out until a record is selected. Grayed out icons indicate they are not active. 

• Configure: Click to Configure, by Properties, or by Questions
• Details: Click to open the Question Exclusions Details at the right of the window
• Delete: Click to delete a Question Exclusion Group
• Filters: A solid filter Indicates filters are set in the columns. Click to clear filters.

Configure by Properties

1. Click the Configure icon in the toolbar. 
2. Select Configure by Properties. The Configure Question Exclusions window opens.
3. From the Study Properties to Exclude On section on the left, use the arrows to expand the sections and select the property. Based on your selection, the associated questions display on the right.
4. From the Questions to be Excluded section on the right, select the question(s). To select all questions within a category, select the category. If more than one question is selected, use the Details View to see all selected questions.
5. Click Save. A confirmation dialogue box briefly displays.

Configure by Questions

1. Click the Configure icon in the toolbar. 
2. Select Configure by Questions. The Configure Question Exclusions window opens.
3. From the Questions section on the left, use the arrows to expand the sections and select the question. Based on your selection, the associated properties display on the right.
4. From the Properties to be Excluded section on the right, select the property(ies), i.e., Therapeutic Areas, Programs, Compounds, Study Phase, and Studies. To select all items within a main property, select the main property and all items in that property are checked. 
5. Click Save. A confirmation dialogue box briefly displays.

View Question Exclusions Details

1. Highlight a row and click the Details icon, double-click a row, or right-click a row and select Details.
2. The Question Exclusion Details window opens at the right of the window displaying record details. When multiple questions are selected when configuring by proprieties, all selected questions display in the Details View.
3. To close the Question Exclusions Detail window, click the X.

Delete a Question Exclusion

1. Select the Question Exclusion(s) by checking the box(es) at the left and click the Delete icon, or right-click a row and select Delete. 
2. A Delete Question Exclusion Group window opens asking if you are sure you want to delete. Click Delete. A confirmation dialogue box briefly displays.

Categories

Categories provides a list of industry-standard categories of risk that can be added to or edited. 

Columns include Sequence, Category Name, Objective, and Status.

Toolbar options (except for the Add and Reorder icons) are grayed out until a record is selected. Grayed out icons indicate they are not active. 

• Add: Click to Create a new Category
• Edit: Click to Edit a Category
• Details: Click to open the Category Details at the right of the window
• Reorder: Click to open the Reorder Risk Category window
• Change Status: Click to change status, options include Activate or Inactivate
• Delete: Click to delete a Category
• Filters: A solid filter Indicates filters are set in the columns. Click to clear filters.

Add a New Category

1. Click the Add icon. The Create New Risk Category window opens.
2. Enter the Category Name (required).
3. Enter the Objective (optional).
4. Click Save. A confirmation dialogue box briefly displays. 

Edit a Category

1. From the listing, click a row and select the Edit icon, or right-click a row and select Edit or from the Category Details, click the Edit icon. The Edit Risk Category window opens.
2. Update the fields.
3. Click Save. A confirmation dialogue box briefly displays. 

Delete a Category

1. Select the Category(ies) by checking the box(es) at the left and click the Delete icon, or right-click a row and select Delete. 
2. A Delete Category window opens asking if you are sure you want to permanently delete the selected category(ies). Click Delete. A confirmation dialogue box briefly displays. 

Important: Categories cannot be deleted when they have questions associated with them. When a user attempts to delete a category that has questions, it is instead placed in an inactive state.

Change the Status of a Category

1. Select categories by checking the box(es) at the left and click the Change Status icon, or right-click a row and select Change Status.
2. Select the Status: Activate or Inactivate.

View Category Details

1. Highlight a row and click the Details icon, double-click a row, or right-click a row and select Details.
2. The Details window opens at the right of the window. From the Category Details you can edit the category and see record details.
3. To close the Question Detail window, click the X.

Reorder Categories

1. Click the Reorder Categories icon. The Reorder Categories window opens.
2. Hover your mouse over the 6 dots and drag the categories to the desired order.
3. Click Save. Or click Cancel to cancel your actions.

Functional Plans

Functional Plans are documents used in the planning and managing of a study. A list of industry-standard functional plans is listed in the RACT. Functional Plans can be added, edited, deactivated, and deleted.

Columns include Functional Plan Name, Tooltip, and Status. By default, the list is filtered by Status to display Active functional plans. 

Toolbar options (except for the Add icon) are grayed out until a record is selected. Grayed out icons indicate they are not active. 

• Add: Click to Create a new Functional Plan
• Edit: Click to Edit a Functional Plan
• Change Status: Click to change status, options include Activate or Inactivate
• Details: Click to open the Functional Plan Details at the right of the window
• Delete: Click to delete a Functional Plan
• Filters: A solid filter Indicates filters are set in the columns. Click to clear filters.

Add a New Functional Plan

1. Click the Add icon. The Create New Functional Plan window opens.
2. Enter the Functional Plan Name (required).
3. Enter Tooltip (optional). Tooltips will display when configuring these items for the Action Plan.
4. Click Save. A confirmation dialogue box briefly displays. The status of the functional plan displays as active.

Edit a Functional Plan

1. From the listing, click a row and select the Edit icon, or right-click a row and select Edit or from the Functional Plan Detail, click the Edit icon. The Edit Functional Plan window opens.
2. Update the fields.
3. Click Save. A confirmation dialogue box briefly displays. 

Delete a Functional Plan

1. Select the Functional Plan(s) by checking the box(es) at the left and click the Delete icon, or right-click a row and select Delete. 
2. A Delete Functional Plan window opens asking if you are sure you want to permanently delete the selected functional plans. Click Delete. A confirmation dialogue box briefly displays. 

Important: Use Caution when deleting Functional Plans, they are permanently deleted.

Change the Status of a Functional Plan

1. Select the Functional Plan(s) by checking the box(es) at the left and click the Change Status icon, or right-click a row and select Change Status.
2. Select the Status: Activate or Inactivate. A confirmation dialogue box briefly displays. 

View Functional Plan Details

1. Highlight a row and click the Details icon, double-click a row, or right-click a row and select Details.
2. The Details window opens at the right of the window. From the Functional Plan Details, you can edit the functional plan, and see record details.
3. To close the Functional Plan Detail window, click the X.

Response Strategies

The Response Strategies provides a list of defined response strategies that have been defined in RACT. Strategies can be added, edited, and deleted.

Columns include Response Category, Response, Tooltip, and Status. By default, the list is filtered by Status to display Active response strategies. 

Toolbar options (except for the Add icon) are grayed out until a record is selected. Grayed out icons indicate they are not active. 

• Add: Click to Create a Response Strategy
• Edit: Click to Edit a Response Strategy
• Change Status: Click to change status, options include Active or Inactive
• Details: Click to open the Response Strategy Detail at the right of the window
• Filters: A solid filter Indicates filters are set in the columns. Click to clear filters.

Add a New Response Strategy

1. Click the Add icon. The Create New Response Strategy window opens.
2. Enter the Response Category (required).
3. Enter the Response (required).
4. Enter Tooltip (optional). Tooltips will display when configuring these items for the Action Plan.
5. Click Save. A confirmation dialogue box briefly displays. The status of the response strategy displays as active.

Edit a Response Strategy

1. From the listing, click a row and select the Edit icon, or right-click a row and select Edit or from the Response Strategy Detail, click the Edit icon. The Edit Response Strategy window opens.
2. Update the fields.
3. Click Save. A confirmation dialogue box briefly displays. 

Delete a Response Strategy

1. Select the Response Strategy(ies) by checking the box(es) at the left and click the Delete icon, or right-click a row and select Delete. 
2. A Delete Response Strategy window opens asking if you are sure you want to permanently delete the selected functional plans. Click Delete. A confirmation dialogue box briefly displays. 

Important: Use Caution when deleting Response Strategies, they are permanently deleted.

Change the Status of a Response Strategy

1. Select the Response Strategy(ies) by checking the box(es) at the left and click the Change Status icon, or right-click a row and select Change Status.
2. Select the Status: Activate or Inactivate. A confirmation dialogue box briefly displays. 

View Response Strategy Details

1. Highlight a row and click the Details icon, double-click a row, or right-click a row and select Details.
2. The Details window opens at the right of the window. From the Response Strategy Details, you can edit the response strategy, and see record details.
3. To close the Response Strategy Detail window, click the X.

Risk Statement Configuration

This lists the fields in the New / Edit Risk Statement window and the columns in the list of Risk Statement list. Custom fields can also be added.

Fields are organized into collapsible sections; use the arrow in the left column to expand or collapse them. Fields can be rearranged within a section by dragging them to the desired location using the 6-dot icon in the left column.

Columns include Field Name, Field Type, Tooltip, Active, Required, and Visible in Table. The 'Active' checkbox is grayed out for required fields. 

Make a Field Visible in the New / Edit Risk Statement Window

Check the box in the 'Active' column for the field to display.

To remove a field from the New / Edit Risk Statement window, uncheck the 'Active' box.

Make a Field Required Entry in the New / Edit Risk Statement Window

Check the box in the 'Required' column for the field to be required entry.

To remove a field from required entry, uncheck the 'Required' box.

Display the Field as a Column in the Risk Statements Table (List)

Check the box in the 'Visible in Table' column for the field to display.

To remove a column from the list, uncheck the 'Visible in Table' box.

Add a Tooltip to a Field as a Hover Over in the New / Edit Risk Statement Window

For a field, click in the Tooltip column, enter the tooltip.

Tooltips can be edited or removed.

Add a Custom Field

Custom field names must be unique and can only include letters and / or numbers.

1. Click the Add Field button at the top right.
2. Select the Section from the drop-down.
3. Enter the Field Name.
4. Select the Field Type from the drop-down: options include Text, Date, or Yes/No.
5. Enter a Tooltip (optional).
6. Check Active for the field to show in the form.
7. Check Required if this field is a required entry.
8. Check Visible in Table if this field should display in the study-level Risk Statements listing.

Edit a Custom Field

Custom fields can be edited; however, if the field is used in a finalized assessment, the Edit Field window will display a warning that some field properties cannot be updated.

1. Scroll to locate the custom field you wish to edit.
2. Click the Edit icon at the right of the row. The Edit Field window opens.
3. Make changes.
4. Click Save.

Delete a Custom Field

Custom fields can be deleted if they are not being used. Custom fields are found at the bottom of the list and have a delete icon (trashcan) at the right. Scroll to view all fields. 

1. Scroll to locate the custom field you wish to delete.
2. Click the Delete icon at the right of the row. The Delete Field window opens.
3. Click Delete to confirm, or click Cancel to cancel your action.

Reorder Fields

Most form fields can be rearranged. 

Hover over the 6-dot icon to the left of a field and drag it to the desired location. Fields can be dragged within a section; however, only custom fields can be moved between sections. Click Save at the top right.

Preview the Risk Statement Form

To preview the Risk Statement form, use the Preview button at the top right. This preview window displays the form based on the current configuration. No updates can be made in the preview window. 

Global Critical Data & Global Critical Processes

Global Critical Data and Global Critical Processes are libraries that can be added to and edited manually or imported from an Excel or CSV file. New studies that are RACT enabled are automatically populated with items listed in Global Critical Data and Global Critical Processes at the time of study creation. Columns include Title and Description. Functionality is the same for Global Critical Data and Global Critical Processes. Initially, there are no critical data / critical processes defined.

Add Critical Data / Critical Process Manually

1. Click the Add Critical Data / Add Critical Process button at the top right.
2. Enter the Title.
3. Enter the Description.

Import Critical Data / Critical Processes

An Excel or CSV file can be used to import critical data / critical processes. Users can create their own template with the columns Title and Description, or if there are existing entries you can first export the file, update it, and then import it.

1. Click the Import icon at the top right. The Import Configuration window opens.
2. Drop or click to browse the Excel or CSV file.
3. Click Import Configuration.

Export Critical Data / Critical Processes

1. Click the Export icon at the top right. 
2. Select Excel or CSV. The file downloads to your computer.

Edit Critical Data / Critical Process

1. Click in field of the row you wish to update.
2. Make the updates. Updates are automatically saved.

Delete Critical Data / Critical Process

Deleted items are removed from the global list but will remain as part of any study specific Risk Assessment if it is in use.

1. Check the box at the left of the row you wish to delete.
2. Click the Delete Critical Data / Process button at the top right. The Delete Critical Data / Process window opens.
3. Click Confirm. Or click Cancel to cancel your action.