Permissions: To access Risk Management Configuration, users must have the Risk Management Configuration privilege.

Risk Management Configuration provides a centralized location to define and manage the configuration used throughout Risk Management. Configuration settings support both RACT and RBQM by establishing shared settings such as Critical to Quality Factors (CTQs), risk assessment components, risk levels, Quality Tolerance Limits (QTLs), and Key Risk Indicators (KRIs), ensuring consistency across risk assessment and risk monitoring activities.

Important: Administrators can require users to provide a justification when editing or deleting QTLs or KRIs by enabling Require Explanation for QTL/KRI Edits and Deletions in User Management > URL Settings. When enabled, users are prompted to enter a justification when editing or deleting QTLs, KRIs, site scoring, country scoring, or risk levels. These actions are recorded in the audit log.

Access the Configuration Page

Selecting the Configuration icon on the Risk Management page opens the Configuration page, where users manage Assessment Settings, CTQs, QTLs, KRIs, Risk Libraries, Functional Plans, Critical Data, Critical Processes, Alerts, and other key components of Risk Management setup.

The Configuration page contains several sections for setting up Risk Management at the URL level, with all items accessible to every study.

Assessment Settings: Combines RACT configuration into a single, version-controlled definition. Assessment Settings determine which CTQs and CTQ Considerations from the CTQ library are available for use, along with the Risk Assessment Form configuration and Risk Level scoring used during RACT assessments. Multiple Assessment Settings can be maintained to support different business needs. 

• Setup: Select and manage CTQs and CTQ Considerations from the CTQ library for use within the Assessment Setting.
• Risk Assessment Form: Configures the fields shown on the Risk Assessment form, including visibility, required status, order, tooltips, and inclusion in summaries. This includes fields such as Contingency Actions used to define actions when a Risk is realized. Custom fields can also be added. The default setup reflects common industry standards and aligns with current regulatory requirements, including ICH E6 R3 and E8 R1.
• Risk Levels: Establish graded scoring bands for Impact, Likelihood, and Detectability. Scale values can be customized to fit internal processes, with a suggested default of 1-4-7-10. An optional weight factor is included in the total risk score calculation, and thresholds can be set to assist in control decisions such as accepting or mitigating risks.

Critical to Quality Factors (CTQs): A centralized library used to create and maintain CTQs and CTQ Considerations across RACT studies. CTQs and CTQ Considerations are managed independently of Assessment Settings and can be activated or inactivated within individual Assessment Settings as needed. Changes made in the CTQ library are applied to future Assessment Setting versions and do not affect ongoing or finalized assessments.

Quality Tolerance Limits (QTLs): A central repository where study-level QTL definitions are created and maintained. QTLs specify acceptable ranges for key study-level metrics and, when linked to risks, help monitor the impact of risks at the study level.

Key Risk Indicators (KRIs): Metrics that track prioritized Risks at site and country levels. When linked to Risks, KRIs can flag conditions that exceed defined thresholds. KRIs are maintained centrally in Risk Management Configuration and made available for RBQM monitoring.

Risk Libraries: Collections of predefined Risks, including CTQs or categories, mitigations, contingency actions, and recommended metrics such as KRIs and QTLs. Selecting a risk from a library auto-populates the Risk Assessment form. elluminate provides a default eCS Risk Library, and additional libraries can be created, updated, imported, and used individually or in combination.

Functional Plans: Centralized list of functional plans available for selection during Risk Assessment activities. Functional Plans define planned oversight or mitigation actions and are configured and maintained in Risk Management Configuration.

Critical Data: Centralized list of potential critical data, available for selection in a drop-down menu while conducting Risk Assessment activities.

Critical Processes: Centralized list of potential critical processes (e.g., Safety Reporting and Escalation), available for selection in a drop-down menu while conducting Risk Assessment activities.

Alerts: This is a centralized list of alerts (actions) maintained in Risk Management. These alerts are referenced by RBQM to support monitoring responses when KRI or QTL thresholds are met.

Note: The CTQ library, QTLs, KRIs, Risk Libraries, Critical Data, Critical Processes, and Alerts are pre-populated with default data.

Important: All fields marked with a red asterisk are required.

Assessment Settings

Select Assessment Settings in the left navigation.

Assessment Settings define the versioned configuration used by the Risk Assessment Categorization Tool (RACT). An Assessment Setting determines which CTQs and CTQ Considerations from the CTQ library, Risk Assessment form fields, and Risk Level scoring definitions are used when conducting a RACT assessment.

Multiple Assessment Settings can be created and maintained to support different therapeutic areas, programs, projects, or organizational standards. Each Assessment Setting is versioned and preserved over time.

Add an Assessment Setting

1. Click the Add Assessment Setting icon in the toolbar. The window opens.
   
2. Enter a Name for the Assessment Setting.
3. Enter a Description.
4. Click Save. After saving, the Assessment Setting Configuration page opens.

Assessment Setting Configuration

Each Assessment Setting is configured using three tabs:

• Setup: Select and activate or inactivate CTQs and CTQ Considerations from the CTQ library for use in the Assessment Setting.
• Form: Configure Risk Assessment form fields.
• Risk Levels: Configure Impact, Likelihood, and Detectability scoring.

When a new Assessment Setting is created, the configuration page opens on the Setup tab, where CTQs and CTQ Considerations from the CTQ library are configured for use in the Assessment Setting.

Manage Assessment Settings

Assessment Settings support updates to both general information and configuration. General information, such as the Name and Description, can be edited from the Assessment Settings page. Configuration changes are managed within the Assessment Setting using the Setup, Form, and Risk Levels tabs.

Edit an Assessment Setting

1. Select the checkbox in the row of the Assessment Setting to modify.
2. Click the Edit icon. The Edit Assessment Setting window opens.
3. Edit the Name or Description.
4. Click Save.

Update an Assessment Setting

1. Click the name of the Assessment Setting to open it.
2. Update the configuration on the Setup, Form, and/or Risk Levels tabs as needed.
3. Click Save.
4. Select one of the following options:
   
   • Save as New Setting: Creates a new Assessment Setting with its own name and version history.
     1. Enter the Name.
     2. Enter the Description.
     3. Click Save.
   • Update Current Setting: Saves the changes as a new version of the existing Assessment Setting.
     1. In the confirmation window, click OK to create a new version of the current Assessment Setting, or Cancel to return without saving.

Versioning Behavior for Assessment Settings

Assessment Settings are versioned objects. Existing RACT assessments continue to reference the Assessment Setting version that was active when they were created.

Changes saved to the Setup, Form, or Risk Levels tabs create a new version of the Assessment Setting. Changes made in the CTQ library are applied when a new Assessment Setting version is created.

Ongoing and finalized assessments are not impacted by updates made in the CTQ library.

Important: Critical to Quality Factors (CTQs) and CTQ Considerations are maintained in the CTQ library. Assessment Settings define which CTQs and CTQ Considerations are available for use within a specific configuration, along with the Risk Assessment Form and Risk Levels.

Configure an Assessment Setting

1. From the Assessment Settings page, select the Assessment Setting to configure.
2. Configure the CTQs and CTQ Considerations on the Setup tab.
3. Configure the Risk Assessment form fields on the Form tab.
4. Configure the scoring model on the Risk Levels tab.
5. Click Save.

Setup Configuration

Select the Setup tab.

The Setup tab is used to configure the CTQs and CTQ Considerations included in an Assessment Setting. CTQs and CTQ Considerations are sourced from the CTQ library and can be activated, inactivated, and reordered for the selected Assessment Setting.

Pending CTQ Library Updates

When changes are made in the CTQ library, a notification banner displays on the Setup tab.

The banner identifies the number of CTQs and CTQ Considerations that have been added, edited, or deleted in the CTQ library since the current Assessment Setting version was created.

Changes from the CTQ library are applied when the Assessment Setting is saved as a new version. Existing Assessment Setting versions and ongoing assessments are not impacted.

Add CTQs to an Assessment Setting

1. Click Add CTQ. The Add CTQ window opens.
   
2. Review the list of available CTQs from the CTQ library.
3. Use the Search field to locate specific CTQs, if needed.
4. Select or clear CTQs as needed.
   • Selected CTQs are highlighted and display a checkmark.
   • CTQs already in the Assessment Setting are selected by default.
5. Click Save.

The selected CTQs and associated CTQ Considerations are added to the Assessment Setting.

Note: CTQs and CTQ Considerations are maintained in the CTQ library. Adding or removing CTQs from an Assessment Setting does not create, modify, or delete CTQs in the CTQ library.

Expand or Collapse a CTQ

1. Click the expand / collapse arrow next to the CTQ name.
2. Expand the CTQ to display its CTQ Considerations or collapse it to hide them.

Activate or Inactivate a CTQ

1. Locate the CTQ.
2. Toggle Active on or off.
3. Click Save.

When a CTQ is inactive, its CTQ Considerations are not available in assessments that use the Assessment Setting.

Activate or Inactivate a CTQ Consideration

1. Locate the CTQ Consideration.
2. Select or clear the checkbox in the Active column.
3. Click Save.

The status change applies only to the selected Assessment Setting.

Reorder CTQ Considerations

1. Click and hold the 6-dot icon next to the CTQ Consideration.
2. Drag the CTQ Consideration to the desired position.
3. Click Save.

The updated order is used when conducting assessments with the Assessment Setting.

Save Setup Changes

1. Click Save.
2. Select Update Current Setting or Save as New Setting.

Saving changes creates a new Assessment Setting version.

Form Configuration

Select the Form tab.

The Form tab is used to configure the fields that appear in the Risk Assessment form. This includes fields such as Contingency Actions, which can be used to define actions when a Risk is realized. Fields are organized into collapsible sections aligned with ICH E6 R3 and E8 R1, including Risk Identification, Risk Evaluation, Risk Control and Ownership, and Risk Monitoring.

Each row displays the field's data type, tooltip, and configuration settings. Fields can be activated, marked as required, included in the Risk Summary, reordered, and supplemented with custom fields.

Make a Field Visible in the New / Edit Risk Window

1. Select the checkbox in the Active column of the field to display it. Clear the checkbox to remove the field from the form.
2. Click Save.

Note: When the Active checkbox is selected and unavailable for editing, the field is required in every Risk window and cannot be turned off.

Tip: An alert message displays when leaving the page without saving changes.

Make a Field Required

1. Select the checkbox in the Required column of the field to make it required. Clear the checkbox to make the field optional.
2. Click Save.

Display a Field in the Risk Summary Listing

1. Select the checkbox in the Include in Risk Summary column of the field to include it as a column in the Risk Summary listing. Clear the checkbox to remove the column from the listing.
2. Click Save.

Add or Edit a Tooltip

1. Click inside the Tooltip column of the field and enter or update the tooltip text.
2. Press Enter.
3. Click Save.

Add a Custom Field

1. Click Add Field. The Add Field window opens.
2. Select the Section.
3. Enter the Field Name.
4. Select the Field Type. Options include Text, Date, or Yes/No.
5. Enter the Tooltip text displayed on hover.
6. Select Active to display the field on the form.
7. Select Required to make the field mandatory.
8. Select Include in Risk Summary to display the field as a column in the Risk Summary.
9. Click Save. The field is added as a new row.

Edit a Custom Field

1. Click the Edit icon for the field to modify. The Edit Field window opens.
2. Edit the Section, Field Name, Field Type, Tooltip, Active, Required, or Visible in Table.
3. Click Save.

Note: Custom fields can be edited. If the field is used in a finalized assessment, a warning message indicates that some field properties cannot be updated.

Delete a Custom Field

1. Click the Delete icon for the field to delete.
2. Click OK in the confirmation window. A success message displays.

Note: Only Custom fields can be deleted, and they must no longer be in use.

Reorder Fields

1. Hover over the 6-dot icon for the field.
2. Drag the field to the desired position within the section. Custom fields can be moved between sections.
3. Click Save.

Preview the Risk Form

1. Click Preview.
2. Review the read-only version of the Risk form to verify labels, field order, and required fields.
3. Close the preview.

Risk Levels

Select the Risk Levels tab.

Risk Levels are configured on the Risk Levels tab of an Assessment Setting.

Risk Levels define the scoring ranges used in numeric calculations within a Risk card. This tab defines which dimensions are evaluated, including Impact, Likelihood, and Detectability. It also defines level names, numeric scores, and color indicators, the RPN formula, and thresholds used to calculate the overall Risk Priority Number (RPN).

Risk Levels

• Impact, Likelihood, and Detectability columns: Each dimension allows up to six levels. Use the toggle to activate or deactivate the dimension.
• Level: Free-text label that appears on the Risk form and Risk cards.
• Score: Value that represents the level. Default settings are 1-4-7-10 based on industry standards and can be customized. Higher Impact and Likelihood values indicate greater concern. Detectability uses a reverse scale.
• Evaluate Toggle: Activates or deactivates an entire dimension. When deactivated, the column is ignored in the RPN formula.
• Row Toggle: Removes an individual level without deleting it and recalculates valid scores.
• Colors: Visual indicators used to distinguish risk levels on Risk cards and RBQM dashboards.

Overall Risk Score (RPN) 

The engine multiplies the active dimension scores, Impact x Likelihood x Detectability, and then multiplies that value by the Weight. 

• Weight: Scales every RPN up or down without changing individual scores.
• Risk Control Threshold: Determines the risk control strategy. Any RPN equal to or above this threshold sets the risk control to Mitigate. Any RPN below this threshold sets the risk control to Accept. The control can be overridden.

RPN Threshold Sliders

Drag the sliders to set the cut points that convert the numeric RPN into the three risk-level bands used throughout RACT and RBQM (green = Low, yellow = Medium, red = High). These thresholds are generated automatically for new Risk cards and support the color-coded widgets displayed on RBQM dashboards.

Critical to Quality Factors (CTQs)

Select Critical to Quality Factor in the left navigation.

The CTQ library provides a centralized repository for managing Critical to Quality Factors (CTQs) and CTQ Considerations across all RACT studies. CTQs and CTQ Considerations are created, maintained, and versioned in the library, then selected for use within Assessment Settings.

Using a centralized CTQ library helps ensure CTQs remain unique and consistent across RACT studies and downstream workflows, including RBQM and IDRP.

Changes made in the CTQ library do not impact ongoing or finalized assessments. Updates become available the next time an Assessment Setting version is created.

Note: CTQs and CTQ Considerations are maintained in the CTQ library. Assessment Settings control which CTQs and CTQ Considerations are used for a specific RACT configuration.

Add a CTQ

1. Click Add CTQ. The Add Critical to Quality Factor window opens.
   
2. Enter the Name.
3. Enter the Description.
4. Click Save. The CTQ is added to the CTQ library and displays in alphabetical order.

Delete a CTQ

1. Click the Delete icon in the row of the CTQ to delete.
2. In the Delete CTQ / Consideration confirmation window, click Delete to remove the CTQ and all associated CTQ Considerations, or Cancel to return without making changes.
3. A success message displays.

Add a CTQ Consideration

1. Click Add Consideration for the selected CTQ. The Add Consideration window opens.
   
2. Enter the Consideration. This text is used as the assessment question.
3. Enter the Abbreviation. The abbreviation is displayed when creating or editing a Risk Assessment.
4. Select a Therapeutic Area to associate with the CTQ Consideration, enabling filtering and searching.
5. Select a Program to associate with the CTQ Consideration, enabling filtering and searching.
6. Enter the Description.
7. Click Save. The CTQ Consideration is added to the selected CTQ.

Edit a CTQ Consideration

1. Click the Edit icon in the row of the Consideration to modify. The Edit Consideration window opens.

   

2. Edit the Consideration, Abbreviation, Therapeutic Area, Program, or Description.
3. Click Save. The updates are saved to the CTQ library.

Note: Changes made to a CTQ Consideration in the CTQ library are applied to future Assessment Setting versions and do not impact ongoing or finalized assessments.

Delete a CTQ Consideration

1. Click the Delete icon in the row of the CTQ Consideration to delete.
2. In the Delete CTQ / Consideration confirmation window, click Delete to remove the CTQ Consideration from the CTQ, or Cancel to return without making changes.
3. A success message displays.

Quality Tolerance Limits (QTLs)

Select Quality Tolerance Limits in the left navigation.

This configuration page lists QTLs in a grid where QTLs can be added, edited, activated, inactivated, deleted, filtered, and sorted from one location. Each row displays the QTL name, description, category, CTQ, and status. 

Add a QTL

1. Click the Add icon. The Add Quality Tolerance Limit window opens.
   
2. Enter the Name.
3. Enter the Abbreviation. When configured, the abbreviation displays in RBQM dashboards.
4. Select the Critical to Quality Factor, if needed.
5. Select the Category, or enter a new category and click Add. The category is saved for future use.
6. Enter the Description.
7. Set the Status. The status is set to Active by default. Set the status to Inactive to keep the QTL in the library and exclude it from RBQM runs.
8. Click Save. A success message displays, and the QTL is added to the listing.

Note: Edits and deletions of QTLs may require justification when a URL-level setting is enabled.

Edit a QTL

1. Select the checkbox in the row of the QTL to modify.
2. Click the Edit icon. The Edit Quality Tolerance Limit window opens.
3. Edit the Name, Critical to Quality Factor, Category, Description, or Status.
4. Click Save. A success message displays, and the updated QTL displays in the listing.

Activate or Inactivate QTLs

1. Select the checkbox for each QTL to update.
2. Click the Change Status icon and select Activate or Inactivate.
3. A success message displays. 

Delete a QTL

1. Select the checkbox for each QTL to delete.
2. Click the Delete icon.
3. In the confirmation window, click OK to delete the QTL, or Cancel to return without making changes.
4. A success message displays.

RBQM Integration

Quality Tolerance Limits (QTLs) defined in Risk Management Configuration are available for selection in RBQM study-level configuration. When linked to RBQM, QTLs support centralized monitoring and issue generation based on defined thresholds.

QTL Filters and Sorting

Columns can be sorted and filtered using standard elluminate grid functionality.

1. Click any column header to display sorting options and the Filter option.
2. Select Filter and enter filter criteria.
3. The Filters icon in the toolbar turns solid when a column filter is active. Click the icon and select Clear Filters to remove all filters, or clear filters individually as needed.

Key Risk Indicators (KRIs)

Select Key Risk Indicators in the left navigation.

KRIs are listed in a grid where KRIs can be added, edited, activated, inactivated, deleted, filtered, and sorted from one location. Each row displays the KRI name, description, Risk Indicator Guidance, category, Critical to Quality Factor, and status. 

Add a KRI

1. Click the Add icon. The Add Key Risk Indicator window opens.
2. Enter the Name.
3. Enter the Abbreviation. When configured, the abbreviation displays in RBQM dashboards.
4. Enter the Description. Include the approach to the KRI parameters and thresholds.
5. Enter Risk Indicator Guidance to guide Central Monitor investigation and follow-up.
6. Select the Critical to Quality Factor, if needed.
7. Select the Category, or enter a new category and click Add. The category determines how the KRI is visually grouped on the RBQM Overview Dashboard and is saved for future use.
8. Set the Status. The status is set to Active by default. Set the status to Inactive to keep the KRI in the library and exclude it from the RBQM engine.
9. Click Save. A success message displays, and the KRI is added to the listing.

Note: Edits and deletions of KRIs may require justification when a URL-level setting is enabled.

Edit a KRI

1. Select the checkbox in the row of the KRI to update.
2. Click the Edit icon. The Edit Key Risk Indicator window opens.
3. Edit the Name, Description, Risk Indicator Guidance, Critical to Quality Factor, Category, or Status.
4. Click Save. A success message displays, and the updated KRI displays in the listing.

Activate or Inactivate KRIs

1. Select the checkbox for each KRI to update.
2. Click the Change Status icon and select Activate or Inactivate.
3. A success message displays. 

Delete a KRI

1. Select the checkbox for each KRI to delete.
2. Click the Delete icon.
3. In the confirmation window, click OK to delete the KRI, or Cancel to return without making changes.
4. A success message displays.

RBQM Integration

Key Risk Indicators (KRIs) defined in Risk Management Configuration are available for selection in RBQM study-level configuration. When linked to RBQM, KRIs support centralized monitoring and issue generation based on defined thresholds.

KRI Filters and Sorting

Columns can be sorted and filtered using standard elluminate grid functionality.

1. Click any column header to display sorting options and the Filter option.
2. Select Filter and enter filter criteria.
3. The Filters icon in the toolbar turns solid when a column filter is active. Click the icon and select Clear Filters to remove all filters, or clear filters individually as needed.

Note: When QTLs or KRIs are marked Inactive, they are removed from active use. However, historical data and prior links remain intact for audit purposes.  

Risk Libraries

Select Risk Libraries in the left navigation.

Risk Libraries store collections of pre-configured Risks that can be selected when adding a Risk under a CTQ Consideration in a RACT assessment. This page presents a two-pane view where the upper grid lists each library and the lower grid displays the Risks associated with the selected library. From this page, Risk Libraries and Risks can be added, edited, imported, activated, or inactivated.

Add a Risk Library

1. Click the Add Risk Library icon in the Risk Libraries section. The Add Risk Library window opens.
   
2. Enter the Name.
3. Enter the Description. Include a summary of the library's purpose.
4. Review the Number of Risks. This counter updates automatically as Risks are added to the library.
5. Review the Version. The version starts at 1 and updates automatically when the Risk Library is modified and saved.
6. Set the Status. The status is set to Active by default. Set it to Inactive to keep the library and its contents in the configuration while preventing them from being selected for new Risks. Existing Risks previously populated from the library remain unchanged for audit purposes.
7. Click Save. The new library is added to the Risk Libraries section, and an empty Risks section is ready to receive Risks.

Edit a Risk Library

1. Select the checkbox in the row of the Risk Library to update.
2. Click the Edit icon. The Edit Risk Library window opens.
3. Edit the Name, Description, or Status.
4. Click Save.

Add a Risk to a Risk Library

1. Select the checkbox in the row of the Risk Library. 
2. Click the Add Risk icon in the Risks section.
   
3. Enter the Risk ID. Once saved, the Risk ID is locked and cannot be edited.
4. Set the Status. The status is set to Active by default. Set it to Inactive to keep the Risk in the library while preventing it from being selected for new assessments. Existing references remain available for audit purposes.
5. Select the Level, if needed. Use Level and Level, Specify to distinguish global, program, or other levels at which the Risk applies. Select an existing value or enter a new value and click Add. New values are saved for future use.
6. Enter Level, Specify, if needed. This field provides additional detail for the selected Level. For example, if Level = Therapeutic Area, enter Cardiovascular in Level, Specify. Select an existing value or enter a new value and click Add. New values are saved for future use.
7. Select the Associated CTQ Factor.
8. Select the Category, or enter a new category and click Add. New categories are saved for future use.
9. Select the Sub-Category, or enter a new sub-category and click Add. New sub-categories are saved for future use.
10. Enter the Risk Description. Include the event, cause, and potential impact of the Risk.
11. Select one or more Functional Plans.
12. Select the Pre-Study Mitigation, or enter a new value and click Add. New values are saved for future use.
13. Select the During Study Mitigation, or enter a new value and click Add. New values are saved for future use.
14. Select the Contingency Actions, or enter a new value and click Add. New values are saved for future use. Contingency Actions define recommended actions to take when a Risk is realized despite mitigation efforts.
15. Enter Trial Level Metric Recommendations. Use this field to suggest QTLs or other metrics that should monitor the Risk at the trial level.
16. Enter Metric Recommendations. Use this field to suggest KRIs that should monitor the Risk at the site or country level.
17. Select Process Metrics, or enter a new value and click Add. New values are saved for future use.
18. Click Save. A success message displays, and the Risk is added to the selected Risk Library.

View Risk Details

• Click the row of the Risk to open the Details panel.

Edit a Risk

1. Select the checkbox in the row of the Risk to update, or open the Details panel.
2. Click the Edit icon in the Risks section or the Edit icon in the Details panel. The Edit Risk window opens.
3. Edit the Status, Level, Level, Specify, Associated CTQ Factor, Category, Sub-Category, Risk Description, Functional Plans, Pre-Study Mitigation, During Study Mitigation, Contingency Actions, Trial Level Metric Recommendations, Metric Recommendations, or Process Metrics.
4. Click Save. A success message displays, and the updated Risk is saved to the library.

Activate or Inactivate Risk Libraries and Risks

1. Select the checkbox for each Risk Library or Risk to update.
2. Click the Change Status icon and select Activate or Inactivate.
3. A success message displays.

Note: Status can also be changed while creating or editing a Risk Library or Risk.

Note: Risk Libraries and the individual risks they contain are permanent system records. They cannot be deleted; instead, set their Status to Inactive when they should no longer be used. Inactivation removes the item from selection lists while preserving historical links and audit traceability.

Import a Risk Library

1. In the Risk Libraries grid, click the Export icon and select Download Risk Template. The template includes the required column headers.
2. Add or edit rows in Excel. Leave the Risk ID column blank for new Risks. Include the existing Risk ID to update a Risk already in the library.
3. Select the checkbox in the row of the Risk Library to receive the Risks.
4. Click the Import icon.
5. Drag and drop the completed Excel file, or browse to select it.
6. Use Add to Library, if needed, to assign incoming Risks to a specific library.
7. Click Import. The system validates the file and displays a success message when the import is complete.

Export a Risk Library

• Export an entire library: Select the checkbox in the row of the Risk Library to export. Click the Export icon and select Excel. The file includes every active Risk in the library.
• Export a subset of risks: Select the checkbox in the row of the Risk Library first. Then, select the checkboxes for the specific Risks in the lower grid before selecting Export. Only the selected Risks are included in the Excel file.

Functional Plans

Select Functional Plans in the left navigation.

The Functional Plans section contains a master list of documents used for study planning and management. Functional Plans appear in the Functional Plan drop-down menu when Risks are created or edited. Each row displays the plan name, optional tooltip, and status.

Add a Functional Plan

1. Click the Add icon in the toolbar. The New Functional Plan window opens.
   
2. Enter the Functional Plan Name.
3. Enter the Tooltip text displayed on hover.
4. Set the Status. The status is set to Inactive by default. Active plans are available for selection in drop-down menus, while Inactive plans remain in the list but are not available for selection.
5. Click Save. The Functional Plan is added to the listing.

Edit a Functional Plan 

1. Select the checkbox in the row of the Functional Plan to modify, or open the Functional Plan Details panel.
2. Click the Edit icon in the toolbar or the Edit icon in the Functional Plan Details panel. The Edit Functional Plan window opens.
3. Edit the Functional Plan Name, Tooltip, or Status.
4. Click Save. A success message displays, and the updated Functional Plan displays in the listing.

Delete a Functional Plan 

1. Select the checkbox for each Functional Plan to delete.
2. Click the Delete icon.
3. In the warning message, click Delete to remove the Functional Plan, or Cancel to return without making changes.

4. A success message displays.

   Note: The item is removed from the global list but remains preserved in any study where it was already referenced.

Activate or Inactivate Functional Plans

1. Select the checkbox for each Functional Plan to update.
2. Click the Change Status icon and select Activate or Inactivate.
3. A success message displays. 

Functional Plans Filters and Sorting

Columns can be sorted and filtered using standard elluminate grid functionality.

1. Click any column header to display sorting options and the Filter option.
2. Select Filter and enter filter criteria.
3. The Filters icon turns solid when a column filter is active. Click the icon and select Clear Filters to remove all filters, or clear filters individually as needed.

View Functional Plan Details

1. Select the checkbox in the row of the Functional Plan and click the Details icon, or double-click the row of the Functional Plan.
2. The Functional Plan Details panel opens.

Critical Data and Critical Processes

Select Critical Data or Critical Processes in the left navigation.

Critical Data and Critical Processes are centrally managed lists that include a Title and Description. Both lists are available for use across studies, allowing studies to reference the same items. Both pages have identical functionality and layout.

Add Critical Data / Critical Process Manually

1. Click Add Critical Data / Process. A new row is added to the listing.
2. Enter the Title.
3. Enter the Description.
4. Press Enter. The item is added to the listing.

Import Critical Data / Critical Processes

1. Click the Import icon. The Import Configuration window opens.
2. Drag and drop an Excel or CSV file containing Title and Description columns, or browse to select the file.
3. Click Import Configuration. The system validates each row, adds new records, and skips duplicates.
4. A success message displays.

Export Critical Data / Critical Processes

1. Click the Export icon and select Excel or CSV.
2. The file downloads with any active filters applied. Clear filters before exporting to include all rows.

Edit Critical Data / Critical Process

1. Click directly in the Title or Description cell to activate inline editing.
2. Make the changes. Edits save automatically when the cursor leaves the cell.

Delete Critical Data / Critical Process

1. Select the checkbox for each Critical Data or Critical Process item to delete.
2. Click Delete Critical Data / Process.
3. In the confirmation window, click Confirm to delete the item, or Cancel to return without making changes.
4. A success message displays.

Note: The item is removed from the global list but remains preserved in any study where it was already referenced.

Critical Data / Critical Process Sorting and Filtering

Columns can be sorted and filtered using standard elluminate grid functionality.

1. Click any column header to display sorting options and the Filter option.
2. Select Filter and enter filter criteria.
3. The Filters icon turns solid when a column filter is active. Click the icon and select Clear Filters to remove all filters, or clear filters individually as needed.

Alerts

Select Alerts in the left navigation. 

The Alerts section contains global labels used by RBQM Alerts. Alerts can be added, edited, activated, inactivated, deleted, filtered, and sorted from one location.

Add an Alert 

1. Click the Add Alert icon. The Add Alert window opens.
   
2. Enter the Name. The alert displays exactly as entered in Action rules.
3. Set the Status. The status is set to Active by default. Set it to Inactive to keep the Alert in the library while preventing it from being selected for new configurations. Historical actions that reference the Alert remain unchanged and available for audit purposes.
4. Click Save. A success message displays, and the Alert is added to the listing. 

Edit an Alert

1. Select the checkbox in the row of the Alert to modify.
2. Click the Edit icon. The Edit Alert window opens.
3. Edit the Name or Status.
4. Click Save. A success message displays.

Activate or Inactivate Alerts

1. Select the checkbox for each Alert to update.
2. Click the Change Status icon and select Activate or Inactivate.
3. A success message displays.

Delete an Alert

1. Select the checkbox for each Alert to delete.
2. Click the Delete icon.
3. Click OK to delete the Alert, or Cancel to return without making changes.
4. A success message displays.

Alert Filters and Sorting

Columns can be sorted and filtered using standard elluminate grid functionality.

1. Click any column header to display sorting options and the Filter option.
2. Select Filter and enter filter criteria.
3. The Filters icon turns solid when a column filter is active. Click the icon and select Clear Filters to remove all filters, or clear filters individually as needed.

Toolbar Icons and Actions

Icon	Icon Name	Description
	9-dot	Opens the Platform Menu.
	elluminate Logomark	Returns the user to the configured Home Page.
	Filter	Filters RACT, RBQM, and Risk Signal cards on the Risk Management page.
	Search	Searches RACT, RBQM, and Risk Signal cards by Study or Program.
	Favorites	Shows or hides studies marked as favorites.
	Configuration	Opens Risk Management Configuration.
	Notifications	Opens the user’s notifications.
	Help	Opens the Help menu (Help Center, Community, Learning Portal, Support Information, Privacy Policy, Legal Notices, and elluminate Version).
	Start New Assessment	Starts a new RACT assessment.
	Run RBQM Engine	Initiates a new RBQM run.
	Favorites	Marks a study as a favorite.
	Back	Returns to the Risk Management page.
	Blue Badge	Displays the number of items listed on the page.
	Add	Adds a new item.
	Edit	Edits an existing item.
	Change Status	Activates or inactivates an item.
	Delete	Deletes an item.
	Filters	Opens filter options. If highlighted, filters are applied to the page.
	6-dot	Drag and drop items to reorder.
	Details	Opens the Details panel for the selected item.
	Export	Exports Risk Libraries, Risks, Critical Data, or Critical Processes to Excel or CSV.
	Import	Imports Risks, Critical Data, or Critical Processes.
	Previous Page	Navigates to the previous page.
	Next Page	Navigates to the next page.