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

Configuration for the Risk Assessment Categorization Tool (RACT) is managed in Risk Management Configuration. Consolidating these tasks within Risk Management streamlines configuration and provides a single location for expanding Risk Management capabilities.

Access the Configuration Page

Selecting the Configuration icon on the Risk Management page opens the Configuration page, which is where users define CTQs, QTLs, KRIs, functional plans, and other key metrics. 

The Configuration page includes 10 sections used to configure the RACT at the URL level, with all items accessible to every study. 

• Critical to Quality Factors (CTQs): This section combines the RACT categories and question library onto a single configuration page. The CTQs are similar to the categories in our legacy RACT, with the CTQ Considerations acting as questions.
• Quality Tolerance Limits (QTLs): A Central repository where study-level QTLs are defined and stored, making them available to every study. QTLs specify acceptable ranges for study-level metrics and, when linked to a RACT Risk, allow monitoring of the associated Risk 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 areas that exceed defined thresholds. All KRIs are maintained in Risk Management Configuration.
• Risk Libraries: Collections of predefined Risks, with CTQs / Categories, mitigations, and recommended metrics (KRIs, QTLs, and others). Choosing a Risk from a library auto-populates the Risk Assessment form with its mitigations and suggested monitoring metrics. elluminate provides a default eCS Risk Library based on standard industry practices. Additional libraries can be created, updated, or imported, and multiple libraries can be used individually or in combination.
• Risk Assessment: Allows configuration of the fields displayed in the Risk Assessment form. Fields can be shown or hidden, given tooltips, marked as required, and reordered. Custom fields may also be added. The default configuration reflects common industry practices and aligns with current regulations, such as ICH E6, ICH E8, and the MHRA, among others.
• Risk Levels: Defines graded bands that customize dimensions (Impact, Detectability, Likelihood) and scale (up to six levels). Values for each scale point can be tailored to match internal processes; the recommended default is 1‑4‑7‑10. An optional Weight factor is included in the total score formula. A study-level total score (RPN) threshold can be set to guide automatic control decisions, such as accept or mitigate, which users may override if necessary.
• Functional Plans: List of Functional Plans available in a drop-down menu while conducting a Risk Assessment. This list is 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), 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. RBQM Actions reference these alerts.

Note: CTQs and CTQ Considerations, 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.

Critical to Quality Factors (CTQs)

The CTQs section is a single workspace that combines CTQs (formerly Categories) with their CTQ Considerations (formerly Questions), allowing users to create, edit, reorder, activate, or inactivate both elements in one view, simplifying configuration for all studies.

Add a CTQ

1. Click the Add CTQ button. The Add Critical to Quality Factor window opens.
2. Name: Enter a suitable name for the CTQ.
3. Status: Set to Active by default; toggling to Inactive excludes the CTQ and CTQ Considerations from future risk assessments. Existing risk assessments are not affected.
4. Comments: Enter comments.
5. Click Save.

Edit a CTQ

1. Click the Details icon to the far right of the CTQ row. The Details panel opens.
2. Click the Edit icon. The Edit Critical to Quality Factor window opens.
3. Edit the Name, Status, or Comments.
4. Click Save. The version automatically increases by 1. 

Note: A CTQ cannot be deleted or sorted once it has been created; it can only be marked as Inactive.

Add a Consideration to the CTQ

1. Click the Add Consideration button for the selected CTQ. The Add Consideration window opens.
2. Consideration: Enter the risk question for the CTQ.
3. Abbreviation: Enter a brief description of the question. This displays when creating or editing a Risk Assessment.
4. Status: It is Active by default; toggling to Inactive prevents it from appearing in any future assessments.
5. Therapeutic Area: Use the drop-down to select a Therapeutic Area to assign to the CTQ, which enables filtering and searching.
6. Program: Use the drop-down to select a Program to assign to the CTQ, to enable filtering and searching.
7. Comments: Enter comments.
8. Click Save.

Edit a Consideration

1. Click the row of the Consideration to be modified. The Details panel opens.
2. Click the Edit icon in the Details panel or the Edit icon in the row of the Consideration. The Edit Consideration window opens.
3. Edit the Consideration, Abbreviation, Status, Therapeutic Area, Program, or Comments.
4. Click Save. The version automatically increments by 1.

Activate / Inactivate a Consideration

1. Click the row of the Consideration and check the box to the right of the CTQ Consideration. Checked marks it as Active, while unchecked marks it as Inactive.

2. Click Save. Users receive an alert if attempting to leave without saving changes. 

   Note: The Status can also be marked as Active / Inactive while editing a Consideration.

Reorder Considerations

1. To sort the Considerations of a CTQ, hover the mouse over the 6-dot icon to the left of the question. Drag the Considerations to the desired order.
2. Click Save. Users receive an alert if attempting to leave without saving changes. 

Delete Considerations

1. Click the Delete icon on the row of the Consideration to delete.
2. Click OK on the window that displays. A success message displays.

Quality Tolerance Limits (QTLs)

This configuration section lists every QTL in a simple grid, allowing users to add, edit, delete, and more from a single location. Each row displays the QTL Name, Description, Category, CTQ, and Status, making it easy to scan what is active. 

Add a QTL

1. Click the Add icon in the toolbar. The Add Quality Tolerance Limit window opens.
2. Name: Enter an appropriate name for the QTL.
3. Abbreviation: Enter a shortened name for the QTL. When configured, this displays in the RBQM dashboards.
4. Critical to Quality Factor: Select the CTQ from the drop-down menu if desired.
5. Category: Choose an existing category from the drop-down or type in a new category and click the Add button that appears. The category is saved for future use.
6. Description: Provide a brief explanation of the QTL.
7. Status: It is set to Active by default; toggling it to Inactive keeps the QTL in the library, but RBQM runs skip it.
8. Click Save. A success message displays, and the new QTL is added to the listing on the page.

Edit a QTL

1. Check the box in the row of the QTL to modify.
2. Click the Edit icon in the toolbar. The Edit Quality Tolerance Limit window opens.
3. Users can edit the Name, Critical to Quality Factor, Category, Description, and Status.
4. Click Save. A success message displays, and the updated QTL is displayed in the listing.

Activate / Inactivate QTLs

1. Check the box on the row(s) of the QTL(s) to change status.
2. Click the Change Status icon and select Activate or Inactivate from the drop-down menu.
3. A success message displays.

Delete a QTL

1. Check the box in the row(s) of the QTL(s) to delete.
2. Click the Delete icon in the toolbar.
3. Click OK on the window that displays. A success message displays.

QTL Filters and Sorting

1. Click any column header to display a drop-down menu for sorting and a Filter option. Choose that option to enter filter criteria.
2. The Filters icon in the toolbar turns solid when any column filter is active. Click it to clear all filters at once.

Key Risk Indicators (KRIs)

KRIs are listed in a simple grid, allowing users to add, edit, delete, filter, and perform other actions in one location. Each row displays the KRI Name, Description, Risk Indicator Guidance, Category, Critical to Quality Factor, and Status, making it easy to see what is available. 

Add a KRI

1. Click the Add icon in the toolbar. The Add Key Risk Indicator window opens.
2. Name: Enter an appropriate name for the KRI.
3. Abbreviation: Enter a shortened name for the KRI. When configured, this displays in the RBQM dashboards.
4. Description: Provide a more detailed explanation of the KRI. It should include the approach to the parameters and thresholds of the KRI.
5. Risk Indicator Guidance: Enter notes that may assist in guiding the Central Monitor in their investigation and subsequent steps in exploring the KRI.
6. Critical to Quality Factor: Select the CTQ from the drop-down menu if desired.
7. Category: This associates the KRI with a metric category, which determines how the KRI is visually grouped on the RBQM Overview Dashboard. Select an existing category from the drop-down menu or enter a new category, then click the Add button that appears. The category is saved for future use.
8. Status: It is set to Active by default; toggling it to Inactive keeps the KRI in the library, but the RBQM engine skips it.
9. Click Save. A success message displays, and the new KRI is added to the listing.

Edit a KRI

1. Check the box on the row of the KRI to update.
2. Click the Edit icon in the toolbar. The Edit Key Risk Indicator window opens.
3. Users can edit the Name, Description, Risk Indicator Guidance, Critical to Quality Factor, Category, and Status.
4. Click Save. A success message appears, and the updated KRI is displayed in the listing.

Activate / Inactivate KRIs

1. Check the box on the row(s) of the KRI(s) to change status.
2. Click the Change Status icon and select Activate or Inactivate from the drop-down menu.
3. A success message displays. 

Delete a KRI

1. Check the box in the row(s) of the KRI(s) to delete.
2. Click the Delete icon in the toolbar.
3. Click OK on the window that displays. A success message displays.

KRI Filters and Sorting

1. Click any column header to display a drop-down menu for sorting and a Filter option. Choose that option to enter filter criteria.
2. The Filters icon in the toolbar turns solid when any column filter is active. Click it to clear all filters at once.

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

Risk Libraries store collections of pre-configured Risks that users reference when adding a risk under a CTQ Consideration in a RACT assessment. This page presents a two-pane view: The upper grid lists each library, including its version and status, while the lower grid instantly displays every pre-configured risk associated with the highlighted library. From this page, users can add, edit, import, or deactivate libraries and their risks.

Add a Risk Library

1. Click the Add icon in the Risk Libraries section.
2. Name: Enter a unique descriptive name for the library.
3. Description: Provide a summary of the library's purpose.
4. Number of Risks: This counter is updated automatically as risks are added to the library.
5. Version: Starts at 1 and updates automatically when the Risk Library is modified and saved.
6. Status: It is set to Active by default; toggling it to Inactive keeps the library and its contents in the configuration but prevents it from being used when users create or edit Risks. Existing risks previously populated from that library remain unchanged for audit history 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. Check the box in the row of the Risk Library to update.
2. Click the Edit icon in the Risk Libraries section. The Edit Risk Library window opens.
3. Users can edit the Name, Description, and Status.

Add a Risk

1. Click the Add icon in the Risks section.
2. Risk ID: Enter a unique name for the Risk within the library.
3. Status: It is set to Active by default; toggling it to Inactive keeps the Risk in the library and makes it no longer available for selection, but retains it for audit history.
4. Level:  Optional. Used to denote the level at which the Risk applies. Combine Level and Level, Specify to distinguish global or program level Risks within the study. Select an existing value from the drop-down, or type in a new value and click Add; the entry is saved for future use.
5. Level, Specify:  Optional. Provides additional detail for the chosen Level. For example, if Level = Therapeutic Area, enter Cardiovascular in Level, Specify. Select an existing value from the drop-down, or type in a new value and click Add; the entry is saved for future use.
6. Associated CTQ Factor: Select the CTQ to link to from the drop-down.
7. Category: Choose an existing category from the drop-down or type in a new category and click the Add button that appears. The Category is saved for future use.
8. Sub-Category: Choose an existing sub-category from the drop-down or type in a new sub-category and click the Add button that appears. The sub-category is saved for future use.
9. Risk Description: Enter a narrative that explains the event, cause, and potential impact.
10. Functional Plan: Select the desired functional plan from the drop-down.
11. Pre-Study Mitigation: Choose an existing pre-study mitigation from the drop-down or type in a new pre-study mitigation and click the Add button that appears. The Pre-Study Mitigation is saved for future use.
12. During Study Mitigation: Choose an existing one from the drop-down or type in a new one and click the Add button that appears. The During Study Mitigation is saved for future use.
13. Trial Level Metric Recommendations: Text field for suggesting Quality Tolerance Limits or alternatives that should monitor this Risk at the trial level.
14. Metric Recommendations: Text field for suggesting Key Risk Indicators that should monitor this Risk at the site or country level.
15. Process Metrics: Choose an existing process metric from the drop-down or type in a new process metric and click the Add button that appears. The Process Metrics is saved for future use. 

View Risk Details

• Click the row of the Risk. The Details panel opens.

Edit a Risk

1. Check the box in the row of the Risk to update.
2. Click the Edit icon in the Risks section or the Edit icon in the details panel. The Edit Risk window opens.
3. Users can edit the Risk ID, Status, Level, Level Specify, Associated CTQ Factor, category, Sub-Category, Risk Description, Functional Plan, Pre-Study Mitigation, During Study Mitigation, Trial Level Metric Recommendations; QTL, Metric Recommendations; KRI, and Process Metrics.
4. Click Save. A success message displays, and the updated Risk is added to the library.

Activate / Inactivate Risk Library and Risks

1. Check the box on the row(s) of the Risk Library or Risk(s) to change status.
2. Click the Change Status icon and select Activate or Inactivate from the drop-down menu.
3. A success message displays

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 in the toolbar and select Download Risk Template. This file contains all the required column headers to use as the template.
2. Add or edit rows directly in Excel. Leave the Risk ID column blank for brand-new risks; include the existing Risk ID to update an item already in the library.
3. Check the box in the row of the Risk Library to add the risks to.
4. Click the Import icon in the toolbar. Drag-and-drop or browse to the completed Excel.
5. Add to Library (Optional): This is where incoming risks can be assigned to a specific library.
6. Click the Import button. The system validates the file and show a success message when done.

Export a Risk Library

• Export an entire library: Check the box on the row of the Risk Library to export. Click the Export icon in the toolbar and select Excel. The file downloads every active risk in the library.
• Export a subset of risks: Check the box on the row of the Risk Library to export first. Then, check the boxes of the specific risks in the lower grid before selecting Export. Only the selected risks are written to the Excel file.

Risk Assessment

The Risk Assessment configuration page manages all fields that appear in the Risk Assessment form. Fields are organized into collapsible sections aligned with ICH E6 R3 and E8 R1: Risk Identification, Risk Evaluation, Risk Control and Ownership, Risk Monitoring, etc. Each row displays the field’s data type, any tooltip, and three toggles: Active (show in the form), Required (make mandatory), and Visible in Table (display as a column in the Risk Summary listing).

Make a Field Visible in the New / Edit Risk Window

1. Check the box in the Active column of the field to display it. Unchecking the box removes the field.

2. Click Save.

   Note: When the Active checkbox is checked and grayed out, it indicates that the field is mandatory in every Risk window and can not be turned off.

   Tip: Users receive a warning message if they attempt to leave without saving.

Make a Field Required

1. Check the box in the Required column of the field to make it a required entry. Unchecking the box removes the mandatory requirement.
2. Click Save.

Display a Field in the Risk Summary Listing

1. Check the box in the Visible in Table column of the field to include as a column in the Risk Summary listing. Unchecking the box removes the column from the listing.
2. Click Save.

Add or Edit a Tooltip

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

Add a Custom Field

1. Click the Add Field button in the toolbar. The Add Field window opens.
2. Select the Section from the drop-down.
3. Type in the Field Name.
4. Select the Field Type from the drop-down. Options include, Text, Date, or Yes/No.
5. Enter Tooltip that appears on hover.
6. Check Active for the field to show up on the form.
7. Check Required if the filed is mandatory.
8. Check Visible in Table if this field should be a column in the Risk Summary.
9. Click Save. The new field displays as a new row on the page.

Edit a Custom Field

1. Click the Edit icon located to the right of the row for the field to modify. The Edit Field window opens.
2. Users can edit the Section, Field Name, Field Type, Tooltip, Active, Required, and Visible in Table.
3. Click Save.

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

Delete a Custom Field

1. Click the Delete icon located to the right of the row for the field to delete.
2. Click OK on the window that displays. A success message displays.

Note: Custom fields can be deleted if they are no longer in use.

Reorder Fields

1. Hover over the 6-dot icon to the left on the row of the field.
2. Drag to desired position within the section (custom fields can move across sections).
3. Click Save.

Preview the Risk Form

1. Click the Preview button.
2. A read-only version of the Risk form opens to verify labels, sort order, and required markers.
3. Close the preview; no changes are saved from this view.

Risk Levels

Risk Levels define the scoring ranges used in every numeric calculation within a Risk card. On this page, administrators choose which dimensions to evaluate: Impact, Likelihood, and Detectability. Then, they assign plain-language level names, numeric scores, and color codes, and set the formula and thresholds that convert those scores into an overall risk priority number (RPN).

Risk Levels

• Impact, Likelihood, Detectability columns: Each dimension allows up to six bands and the scale can be adjusted by turning on/off the toggle on the right.
• Level: Free text label that appears on the Risk form and cards.
• Score: The value representing the band level. Default settings are 1-4-7-10 based on industry standards but can be customized. Impact and Likelihood suggest greater concern with higher values. Detectability has an reverse scale.
• Evaluate Toggle: Activates or deactivates an entire dimension. When turned off, the column is ignored in the RPN formula.
• Row Toggle: Removes an individual band without deleting it, instantly recalculating valid scores.
• Colors are purely visual cues that later appear on Risk cards and dashboards.

Overall Risk Score (RPN) 

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

• Weight: Increase or decrease to scale every RPN up or down without editing individual scores.
• Risk Control Threshold: Enter the RPN threshold that determines the risk control strategy. Any RPN equal to or above this threshold automatically sets the risk control to Mitigate; below the threshold, it sets risk control to Accept. However, the control can be overridden.  

RPN Threshold Sliders

Drag the two colored 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 feed the color-coded widgets on RBQM dashboards.

Functional Plans

The Functional Plans section features a master list of documents used for planning and managing a study. This list appears in the Functional Plan drop-down menu when risks are created or edited. Each row shows the plan’s name, an optional tooltip, and its current status, allowing teams to quickly activate usable plans or retire outdated ones.

Add a Functional Plan

1. Click the Add icon in the toolbar. The New Functional Plan window opens.
2. Functional Plan Name: Enter an appropriate name.
3. Tooltip: Enter message that appears on hover.
4. Status: It is set to Active by default; toggle it to Inactive if the plan should be stored but not offered in drop-downs.
5. Click Save. The new plan appears as a row on the page.

Edit a Functional Plan 

1. Check the box in the row of the Functional Plan to modify.
2. Click the Edit icon in the toolbar. The Edit Functional Plan window opens.
3. Users can edit the Functional Plan Name, Tooltip, and Status.
4. Click Save. A success message displays, and the updated Functional Plan is displayed in the listing.

Delete a Functional Plan 

1. Check the box in the row(s) of the Functional Plans(s) to delete.
2. Click the Delete icon in the toolbar.

3. Click Delete on the window that displays with a warning message. 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 / Inactivate Functional Plans

1. Check the box on the row(s) of the Functional Plans(s) to change status.
2. Click the Change Status icon and select Activate or Inactivate from the drop-down menu.
3. A success message displays.

Functional Plans Filters and Sorting

1. Click any column header to display a drop-down menu for sorting and a Filter option. Choose that option to enter filter criteria.
2. The Filters icon in the toolbar turns solid when any column filter is active. Click it to clear all filters at once.

View Functional Plan Details

• Check the box on the row of the Functional Plans to view details. The Details panel opens.

Critical Data and Critical Processes

Critical Data and Critical Processes are lists that include a Title and Description. Both lists are managed centrally within Risk Management, allowing each study to reference the same items. Note that both pages have identical functionality and layout.

Add Critical Data / Critical Process Manually

1. Click Add Critical Data / Process button. This adds a new row to the Critical Data / Process listing, where users can enter the new Critical Data / Process.
2. Title: Enter an appropriate name. Then click in the Description column to enable data entry.  
3. Description: Type in the description of the Critical Data /Process.
4. Press Enter. The new Critical Data / Process row displays in 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 the file.
3. Click the Import Configuration button. The system validates each row and adds new records and duplicates are skipped. 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 filters applied; clear filters to export 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. Check the box in the row(s) of the Critical Data / Process to delete.
2. Click Delete Critical Data / Process button.

3. Click Confirm on the window that displays. 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

1. Click any column header to display a drop-down menu for sorting and a Filter option. Choose that option to enter filter criteria.
2. The Filters icon in the toolbar turns solid when any column filter is active. Click it to clear all filters at once.

Alerts 

The Alerts section contains global labels that RBQM Actions use. Use this page to add, edit, activate, or deactivate alert phrases.

Add an Alert 

1. Click the Add icon. The Add Alert window opens.
2. Name: Type the alert exactly as it should appear in Action rules.
3. Status: Set to Active by default; toggling it to Inactive keeps the alert in the library. Historical actions that reference the alert continue to function, and the audit trail remains intact, but the inactive alert is no longer available for new configurations.
4. Click Save. A success message displays, and the new Alert is added to the listing. 

Edit an Alert

1. Click Save. A success message displays, and the new Alert is added to the listing.
2. Click the Edit icon. The Edit Alert window opens.
3. Users can edit the Name and Status
4. Click Save. A success message appears, and the updated Alert is displayed in the listing.

Activate / Inactivate an Alert

1. Check the box on the row(s) of the Alerts(s) to change status.
2. Click the Change Status icon and select Activate or Inactivate from the drop-down menu.
3. A success message displays.

Delete an Alert

1. Check the box in the row(s) of the Alerts(s) to delete.
2. Click the Delete icon in the toolbar.
3. Click OK on the window that displays. A success message displays.

Alert Filters and Sorting

1. Click any column header to display a drop-down menu for sorting and a Filter option. Choose that option to enter filter criteria.
2. The Filters icon in the toolbar turns solid when any column filter is active. Click it to clear all filters at once.