Permissions: Users must have the RBQM, Data Central, and Study Configure privileges assigned to a study to configure RBQM in Data Central Configuration. 

Risk Based Quality Management (RBQM) is configured for a study within Data Central Configuration and is directly linked to Risk Management Configuration and RACT. This setup enables CTQs, QTLs, and KRIs to be reused consistently across risk assessments.

A study must be RBQM & RACT enabled for RBQM configuration to be available in Data Central Configuration.

Access Data Central Configuration

From a study card on the Data Central landing page, either click the red triangle (displayed if the study is not yet configured), or the Configuration icon, then select Data Central Configuration.

The Data Central Configuration window for the selected study opens. Click RBQM in the left navigation to access each configuration item.

Configurations can be copied from another study, imported, or exported.

Expand the Study section using the RBQM down arrows in the left navigation. This displays the RBQM study configuration overview. Each section within the study requires configuration.

Important: Library-Linked items

CTQs, QTLs, and KRIs added from the Risk Management Configuration libraries are initially linked to their source definitions and display a checkmark in the Global column in the CTQ, QTL, and KRI listings in Data Central Configuration. While linked, the Name field is read-only.

For QTLs and KRIs, both Name and Category are read-only while linked. For CTQs, the Category may be updated at the study-level to support study-specific organization and reporting.

Configure Study CTQs

Critical to Quality Factors (CTQs) are essential tools for ensuring study reliability, integrity, and regulatory compliance by managing quality and risk. While not required, adding CTQs is recommended. They can be created at the study level or added from Risk Management Configuration. If no CTQs are added, the CTQ View toggle in RBQM dashboards is disabled.

In the left navigation, click Critical to Quality Factors (CTQ) under Study. Added CTQs are displayed in the listing with columns for Name, Description, Category, Acceptable Range(s), Active, Part of Current RACT, and Global. 

Add and Define a Study-Level CTQ

• On the CTQ study configuration page, click the Add icon in the upper right corner to open the menu. Select from:
  • Add CTQ: Creates a new study-level CTQ.

  • Add CTQ From Library: Adds an existing CTQ from Risk Management Configuration.

    

• If a CTQ is linked to Risk Management Configuration, a checkmark appears in the Global column on the CTQ listing.

Add CTQ

1. Select Add CTQ. The New CTQ window opens.

   

2. Name: Enter an appropriate name for the CTQ.
3. Category: Select from the drop-down.
4. Acceptable Range(s) (QTL): Select one or more associated QTLs from the drop-down menu.
5. Description: Enter description of CTQ.
6. Status: By default, Active is selected. Being active, it runs when new data are refreshed.
7. Click Save.

Add CTQ From Library

1. Select Add CTQ From Library. The Add CTQ From Library window opens.

   

2. Select one or more CTQs to add, then click Save.
3. If a selected CTQ is already included in the study, it cannot be added again.
4. CTQs added from the library include basic details configured in Risk Management Configuration.

Unlink a CTQ From Library

1. Select Add CTQ From Library. The Add CTQ From Library window opens, with the CTQs in the study highlighted in blue.
2. Unselect the CTQ checkbox to unlink it from Risk Management and set it to study-level.
3. Click Save. A message displays indicating that the CTQ has been updated to the study level, and the checkmark in the Global column is cleared.

Edit a Study-Level CTQ

1. Click in the row of the CTQ to edit.
2. Click the Edit icon. The Edit CTQ window opens.
3. Make changes as needed. If the CTQ was added from Risk Management Configuration and remains linked, the Name field cannot be edited. 
4. Click Save. 

Delete a Study-Level CTQ

1. Click in the row of the CTQ to delete.
2. Click the Delete icon.
   • Deleting a CTQ only removes it from the current study and does not change the source CTQ in the Risk Management Configuration or other studies.
3. A confirmation window opens. Click OK or click Cancel to cancel the action.
4. Click Save. 

Important: Administrators can require users to provide a justification when editing or deleting QTLs or KRIs by enabling the URL setting, 'Require Explanation for QTL/KRI Edits and Deletions,' in User Management > URL Settings. When enabled, users are required to enter a justification for editing or deleting QTLs, KRIs, Site scoring, Country scoring, or Risk Levels. These actions are recorded in the audit log.

Configure Study QTLs

Quality Tolerance Limits (QTLs) are used to measure the health of a study. They can be added at the study-level or imported from Risk Management Configuration. QTLs imported from Risk Management include basic definitions, while study-specific scoring and thresholds are configured within RBQM.

In the left navigation, click Quality Tolerance Limits (QTLs) under Study. Added QTLs are displayed in the listing with columns for Name, Abbreviation, Description, Category, CTQ, Active, Part of Current RACT, Global. 

Add and Define a Study-Level QTL

• On the Quality Tolerance Limits (QTL) page, click the Add icon in the upper right corner to open the menu. Select from:
  • Add QTL: Creates a new study-level QTL.
  • Add QTL From Library: Adds an existing QTL from Risk Management Configuration.
• If a QTL is linked to the Risk Management Configuration, a checkmark displays in the Global column on the QTL listing.

Add QTL

1. Select Add QTL. The New Quality Tolerance Limits (QTL) window opens. 

   

   General

2. Name: Enter an appropriate name for the QTL.
3. Category: Select from the drop-down.
4. CTQ: Optionally link the QTL to a Critical to Quality Factor. When linked, the QTL helps assess CTQ-level and trial-level risks in RBQM.
5. Abbreviation: Enter an abbreviation that displays in the RBQM dashboards.
6. Description. Enter description of QTL.
7. Status: By default, Inactive is selected. Click the toggle to activate it so that it runs when new data are refreshed.

8. By default, Show current threshold is selected (the threshold line is a straight line based on the current threshold). Select Show dynamic threshold for the threshold line to update when a change to the threshold is made. 

   Study Scoring 

9. Click Study Scoring in the left navigation.

   

10. Enter the Study Query, the SQL statement.
11. Click the Validate button to validate the query. Modify query as needed.

12. Click Save.

    Risk Levels / Alerts

13. Click Risk Levels / Alerts in the left navigation.

    

    Tolerance Limits

14. Enter the Tolerance Limits for Upper Limit, Approaching Upper Limit, Approaching Lower Limit, and Lower Limit. The In Control (exclusive) limit is automatically populated.
15. Edit checks are in place to identify if overlapping values are entered. When Save is clicked, an error message may display, click the 'X' to close the message and update the values.

16. As values are entered, the Gauge Preview on the right updates so users can see what the configured gauge looks like. Update the Sample Score by using the slider.

    Study Risk Actions: Tolerance Exceeded / Approaching Limit / In Control / Approaching Limit
    Apply actions if a QTL has met Tolerance Exceeded.

17. Click one of the Tolerance Limits to create a Study Risk Alert for that limit.
18. Click the Add icon.
19. Click the Name field and select the alert from the drop-down (as configured in Alerts).
20. Enter the number of days in the Due in Days field in which this alert should be completed once the QTL enters the risk level.
21. Click in the Trigger field and select from the drop-down:
    • Always: The alert is displayed every time.
    • When Changed From Previous: The alert is displayed only when the score changes, either to a higher or lower risk level.
    • When Riskier Than Previous: The alert is displayed only when the score results in a higher risk level than before.

22. Click in the Assign To field and select from the drop-down: Data Central role Site Monitor (default) or select from the list.

    Supporting Data

23. Click Supporting Data in the left navigation.

    Supporting data can be defined by adding to the Domains section. Domains added as supporting data in configuration are available in the QTL dashboard.

    

24. Click the Get From Query icon in the Domains area to add a domain from the Study Query (in Study Scoring). If no Study Query is entered, an error message displays.
25. Click the Add Domain icon in the Domains area to add from the drop-down list of available domains. Use the scrollbar to access all domains.
26. Continue adding as needed.
27. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.

28. To remove a domain, click the Delete icon next to a domain.

    Save QTL Configuration

29. Click Save at the bottom right. The new QTL is added to the list.

    Important: If items are not configured correctly, an error message with details displays. Read the message carefully, then click the 'X' to close it and correct the item(s).

Add QTL From Library

1. Select Add QTL From Library.  The Add QTL From Libary window opens.
2. Select one or more QTLs to add, then click Save.
3. If a selected QTL is already included in the study, it cannot be added again.
4. QTLs added from the library include basic details configured in Risk Management. Study-specific thresholds, scoring, and alerts must be configured within RBQM. For details, see Add QTL.

Unlink a QTL From Library

1. Select Add QTL From Library. The Add QTL From Library window opens, with the QTLs in the study highlighted in blue.
2. Unselect the QTL checkbox to unlink it from Risk Management and set it to study-level.
3. Click Save. A message displays indicating that the QTL has been updated to the study level, and the checkmark in the Global column is cleared.

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

Edit a Study-Level QTL

1. Click in the row of the QTL to edit.
2. Click the Edit icon. The Edit QTL window opens.
3. Make changes as needed. If the QTL was added from Risk Management Configuration and remains linked, the Name and Category fields cannot be edited. 
4. Click Save. 

Delete a Study-Level QTL

1. Click in the row of the QTL to delete.
2. Click the Delete icon.
   • Deleting a QTL only removes it from the current study and does not change the source QTL in the Risk Management Configuration or other studies.
3. A confirmation window opens. Click OK or click Cancel to cancel the action.
4. Click Save. 

Note: QTLs referenced in RACT risk evaluations or finalized assessments cannot be deleted. If a QTL is in use, a message displays explaining why the deletion is blocked.

Configure Study KRIs

Key Risk Indicators (KRIs) specify the metrics RBQM uses to monitor study risk at both the site and country levels. Study-level KRIs can be added manually or imported from Risk Management Configuration. When imported, KRIs include basic attributes but must be configured at the study-level with scoring, thresholds, and alert logic.

Add and Define a Study-Level KRI

• On the Key Risk Indicators (KRI) page, click the Add icon in the upper right corner to open the menu. Select from:
  • Add KRI: Creates a new study-level KRI.
  • Add KRI From Library: Adds an existing KRI from the Risk Management Configuration.
• If a KRI is linked to Risk Management Configuration, a checkmark displays in the Global column on the QTL listing.

Add KRI

1. Select Add KRI. The New KRI window opens. 

   

   General

2. Name: Enter an appropriate name for the KRI.
3. Category: Select from the drop-down.
4. CTQ: Optionally link the KRI to a Critical to Quality Factor. When linked, the KRI helps assess CTQ-level and trial-level risks in RBQM.
5. Abbreviation: Enter an abbreviation that displays in RBQM dashboards. 
6. Description: Enter a description of the KRI.
7. Risk Indicator Guidance: Enter recommended actions and next steps for central monitors when a KRI breaches its defined limit. Once configured, the guidance displays in the side panel under the KRI Details tab in the Recommendation field.
8. Status: By default, Inactive is selected. Click the toggle to activate it so that it runs when new data are refreshed.
9. Critical Vs. Not Critical: By default, KRI is Not Critical is selected. Select KRI is Critical to mark critical. If a site exceeds the threshold for a critical KRI, the entire site is flagged as yellow / red, regardless of the overall site score.

10. Weight: Update if needed (1 is default).

    Scoring

11. Click Site Scoring in the left navigation.

    

12. Optionally, check Use CSM (Central Statistical Monitoring). CSM is a method to identify sites statistically different from the 'central' site. (In RBQM, the 'central' site is defined as an aggregate of all sites.) If checked, additional fields display.

    

    1. CSM Type: Select from the drop-down: Continuous, Discrete, or Proportion.
    2. CSM Alpha Value: Select the from the drop-down: .1, 0.05, 0.01, 0.001, 0.0001, 0.00001, or 0.000001.
    3. CSM Measurement Label: Enter the label (Optional).
    4. Sites Query: Enter the sites query.
    5. Validate: Click button to validate the query. Modify query as needed.

    6. Continue to Risk Levels: up to Step 13.

       Note: When CSM scoring is enabled for site-level KRIs, country-level scoring options are disabled. Country scoring can only be configured when CSM scoring is not used.

13. Z Score: Check the is Z Score box, if there is a Z Score calculation required for this indicator.
    In order to use a Z-Score for a given Key Risk Indicator (KRI), the KRI should not be categorical, such as a yes / no variable or 1=mild, 2=moderate, 3=severe. Further, the values of the KRI should not be skewed, meaning the majority of the values should not sit at the high end or the low end within a narrow range with data trailing off to the opposite side. As an example, think of a study where few adverse events are found in subjects. If most of the subjects have 0 events, with a handful having anywhere from 1-10 events, this is not ideal for a z-score. Lastly, there should be at least thirty observations associated with the KRI in order to get meaningful results with a Z-Score.
14. Sites Query: Enter the SQL statement to call the max risk value for each site for the selected indicator. This is a required entry.

15. Validate: Click button to validate the query. A table displays the Site ID, Site Score, and Z-Score (if is Z Score is selected). Modify query as needed. 

    Site Risk Levels / Alerts

    Enter Limits. For example, when looking at enrollment numbers, the lower the number, the higher the risk. Or there may be an AE rate that is too high or too low (e.g., there is a good band in between).

16. Click Risk Levels / Alerts under Site Scoring in the left navigation.

    

17. Site Risk Levels: Enter the levels.
18. Edit checks are in place to identify if overlapping values are entered. When Save is clicked, an error message displays, click the 'X' to close the message and update the values.
19. As values are entered, the Gauge Preview on the right updates so users can see what the configured gauge looks like. Update the Sample Score by using the slider.
    
    Site Risk Alerts: High
    Apply actions if an indicator exceeds the limit.  
20. Click one of the Site Risk Levels, i.e., High (Upper), Medium (Upper), Low (exclusive), Medium (Lower), or High (Lower).
21. Click the Add icon.
22. Click in the Name field and select the action from the drop-down (as configured in Global Actions).
23. Enter the number of days in the Due in Days field in which this action should be completed once the indicator enters the risk level.
24. Click in the Trigger field and select from the drop-down:
    • Always: The alert is displayed every time.
    • When Changed From Previous: The alert is displayed only when the score changes, either to a higher or lower risk level.
    • When Riskier Than Previous: The alert is displayed only when the score results in a higher risk level than before.
25. Click in the Assign To field and select from the drop-down: Data Central role Site Monitor (default), or select from the list.

26. Continue adding Site Risk Actions for each Site Risk Level as needed.

    Supporting Data

27. Click Supporting Data under Site Scoring.

    Supporting data can be defined by adding to the Domains section. Domains added as supporting data in configuration are available in the KRI dashboard.

    

28. Click the Get From Query icon in the Domains area to add a domain from the Sites Query (in Site Scoring). If no Sites Query is entered, an error message displays. Click the 'X' to close the message.
29. Click the Add Domain icon in the Domains area to add from the drop-down list of available domains. Use the scrollbar to access all domains.
30. Continue adding as needed.
31. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.
32. To remove a domain, click the Delete icon next to a domain.

33. Click Country Scoring in the left navigation.

    

34. Enter the Countries Query, the SQL statement to call the max risk value for each country for the selected indicator. This is a required entry.

35. Click the Validate button to validate the query. Modify query as needed.

    Country Risk Levels / Alerts

    Enter the Country Risk Levels limits. For example, when looking at enrollment numbers, the lower the number, the higher the risk. There may be an AE rate that is too high or too low (e.g., there is a good band in between).

36. Click Risk Levels / Alerts under Country Scoring in the left navigation.

    

37. Enter the Country Risk Levels limits. The Low is automatically populated.
38. Edit checks are in place to identify if overlapping values are entered. When Save is clicked, an error message displays, click the 'X' to close the message and update the values.
39. As values are entered, the Gauge Preview on the right updates so users can see what the configured gauge looks like. Update the Sample Score by using the slider.
    
    Country Risk Actions: Low/ Medium / High
    Apply actions if an indicator falls within a certain risk level.  
40. Click one of the Country Risk Actions, i.e., High (Upper), Medium (Upper), Low (exclusive), Medium (Lower) or High (Lower).
41. Click the Add icon.
42. Click in the Name field and select the action from the drop-down (as configured in Global Actions).
43. Enter the number of days in the Due in Days field in which this action should be completed once the indicator enters the risk level.
44. Click in the Trigger field and select from the drop-down:
    • Always: The alert is displayed every time.
    • When Changed From Previous: The alert is displayed only when the score changes, either to a higher or lower risk level.
    • When Riskier Than Previous: The alert is displayed only when the score results in a higher risk level than before.
45. Click in the Assign To field and select from the drop-down: Data Central role Site Monitor (default), or select from the list.

46. Continue adding Country Risk Actions for each Country Risk Level as needed.

    Supporting Data

47. Click Supporting Data under Country Scoring.
    Supporting data can be defined by adding to the Domains section. Domains added as supporting data in configuration are available in the KRI dashboard.
48. Click the Get From Query icon in the Domains area to add a domain from the Countries Query (in Country Scoring). If no Countries Query is entered, an error message displays. Click the 'X' to close the message.
49. Click the Add Domain icon in the Domains area to add from the drop-down list of available domains. Use the scrollbar to access all domains.
50. Continue adding as needed.
51. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.

52. To remove a domain, click the Delete icon next to a domain.

    Save KRI Configuration

53. Click Save. The new KRI is added to the listing. 

Add KRI From Library

1. Select Add KRI From Library. The Add KRI From Library opens.
2. Select one or more KRIs to add to the study, then click Save. 
3. If a selected KRI already exists in the study, it cannot be added again.
4. KRIs added from the library include basic details configured in Risk Management. Study-specific thresholds, scoring, and alerts must be configured within RBQM. For details, see Add KRI.

Unlink a KRI From Library

1. Select Add KRI From Library. The Add KRI From Library window opens, with the KRIs in the study highlighted in blue.
2. Unselect the KRI checkbox to unlink it from Risk Management and set it to study-level.
3. Click Save. A message displays indicating that the KRI has been updated to the study level, and the checkmark in the Global column is cleared..

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

Edit a Study-Level KRI

1. Click in the row of the Indicator to edit.
2. Click the Edit icon. The Edit KRI window opens. If the KRI was added from Risk Management Configuration and remains linked, the Name and Category fields are read-only. 
3. Make changes as needed. If the KRI was added from Risk Management Configuration and remains linked, the Name and Category fields cannot be edited.
4. Click Save. 

Delete a Study-Level KRI

1. Click in the row of the Indicator to delete.
2. Click the Delete icon.
   • Deleting a KRI removes it from the current study only and does not change the source KRI in Risk Management Configuration or other studies.
3. A confirmation window opens. Click OK (or click Cancel to cancel the action).
4. Click Save. This is just removing the Indicator from this study; it is not deleting a Global Indicator.

Note: KRIs referenced in RACT risk evaluations or finalized assessments cannot be deleted. If a KRI is in use, a message displays explaining why the deletion is blocked.

Note: If both RACT and RBQM are enabled, when an RACT assessment is finalized, any CTQs, QTLs, or KRIs used in that assessment that are not already part of the study-level RBQM configuration are automatically added and marked with a checkmark in the Part of Current RACT column. When a new RACT assessment is created and finalized, any previously included items that are not used in the new current assessment will display an information icon with the hover text Removed from current RACT assessment.

Configure Study Sites

For site-level monitoring, the sites table must be loaded; otherwise, configuration cannot continue. The example below shows a correctly entered Sites query.

In the left navigation, click Sites under Study. The SQL Query for Sites window displays.

1. In the empty field, enter the SQL statement that identifies from where the Sites table should be pulled. This statement includes the study, staging area, and then the table name. It must also have the country code for every site in order to enable country functionality with RBQM.

   Tip: Notice there is an underscore between the study name and the staging area, and a period between the staging area and the table name. For example: Select SiteName Name,SiteNumber as SiteId, NULL Address , City,State,null as Zip,Country From ALXN1210_aHUS_311_CTOA.[Sites] where sitename is not null

2. Click the Preview button. The bottom section of the window populates with the Sites table. If this does not display as expected, modify the SQL statement.
3. Click Save when the preview of the Sites table is as expected.

Sites SQL Statement

If the site information is not available from the Operational data, import an .xlsx or .txt file with the site information into elluminate, typically into the Operational staging area. The table should include the Site ID and Location (city, state, zip, country). See below for an example:

Configure Study Alerts

In the left navigation, click Alerts under Study. The list of Alerts is displayed in Low, Medium, and High sections. Alerts at the study-level can be added and deleted. 

Add a Study-Level Alert

1. Click the Add icon in the top right corner.
2. In the Level field select low, medium, or high from the drop-down.
3. Click the Name field and select the alert from the drop-down menu. The list is configured in Risk Management Configuration. Alternatively, users can manually enter an Alert, which is added to the Alerts in Risk Management Configuration.
4. Enter the Due in Days field in which this alert should be completed once the QTL or KRI enters the risk level.
5. Click in the Trigger field and select from the drop-down:
   • Always: The alert is displayed every time.
   • When Changed From Previous: The alert is displayed only when the score changes, either to a higher or lower risk level.
   • When Riskier Than Previous: The alert is displayed only when the score results in a higher risk level than before.
6. Click Save.

Edit a Study-Level Alert

1. Click the Alert name to edit.
2. Edit the Name of the action, Due in Days, and / or Trigger.
3. Click Save. The updated alert displays in the list of Alerts.

Delete Study-Level Alert(s)

1. Click in the box to the left of the alert(s) to delete.
2. Click the Delete icon in the top right corner.
3. A confirmation window opens. Click OK or Cancel to cancel the action.
4. Click Save.