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 Studies 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. Select RBQM in the left navigation to expand the section and access configuration items.

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

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) support study reliability, integrity, and regulatory compliance by managing quality and risk. Adding CTQs is optional but recommended. CTQs 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.

1. In the left navigation, click Critical to Quality Factors (CTQs) under Study.
2. Review the CTQ listing. Columns include Name, Description, Category, Acceptable Range(s), Active, Part of Current RACT, and Global.
   • A checkmark in the Global column indicates the CTQ is linked to the library.

Add and Define a Study-Level CTQ

1. On the CTQ page, click the Add icon.
2. Select one of the following:
   • Add CTQ: Create a new study-level CTQ.
   • Add CTQ From Library: Add an existing CTQ from Risk Management Configuration.

Add CTQ

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

   

2. Enter the following fields:
   • Name: Enter a CTQ name.
   • Category: Select from the drop-down.
   • Acceptable Range(s) (QTL): Select one or more associated QTLs.
   • Description: Enter a description.
   • Status: Active is selected by default and runs when data are refreshed.
3. Click Save.

Add CTQ From Library

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

   

2. Select one or more CTQs.
   • CTQs already included in the study cannot be added again.
   • CTQs include details configured in Risk Management Configuration.
3. Click Save.

Unlink a CTQ From Library

The CTQ is converted to a study-level CTQ, and the checkmark in the Global column is removed.

1. Click the Add icon and select Add CTQ From Library.
2. In the window, clear the checkbox for the CTQ.
3. Click Save.

A message displays indicating that the CTQ has been updated to the study level.

Edit a Study-Level CTQ

1. Select the CTQ row.
2. Click the Edit icon. The Edit CTQ window opens.
3. Update fields as needed.
   • The Name field cannot be edited if the CTQ remains linked to Risk Management Configuration.
4. Click Save.

Delete a Study-Level CTQ

Deleting a CTQ removes it from the current study only. The source CTQ in Risk Management Configuration and other studies is not affected.

1. Select the CTQ row.
2. Click the Delete icon.
3. In the confirmation window, click OK or Cancel.

Important: Administrators can require justification for 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, a justification is required for edits or deletions. This applies to QTLs, KRIs, Site scoring, Country scoring, and Risk Levels. All actions are recorded in the audit log.

Configure Study QTLs

Quality Tolerance Limits (QTLs) measure study health. QTLs can be created at the study level or added from Risk Management Configuration. QTLs added from the library include basic definitions, while study-specific scoring, thresholds, and alerts are configured in RBQM.

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

1. In the left navigation, click Quality Tolerance Limits (QTLs) under Study.
2. Review the QTL listing. Columns include Name, Abbreviation, Description, Category, CTQ, Active, Part of Current RACT, and Global.
   • A checkmark in the Global column indicates the QTL is linked to the library.

Add and Define a Study-Level QTL

1. On the Quality Tolerance Limits (QTL) page, click the Add icon.
2. Select one of the following:
   • Add QTL: Create a new study-level QTL.
   • Add QTL From Library: Add an existing QTL from Risk Management Configuration.

Add QTL

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

   

General

2. Enter the following fields:
   • Name: Enter a QTL name.
   • Category: Select from the drop-down.
   • CTQ: Optionally link to a CTQ to support CTQ-level and trial-level risk assessment.
   • Abbreviation: Enter a value displayed in RBQM dashboards.
   • Description: Enter a description.
   • Status: Inactive is selected by default. Toggle to activate so the QTL runs when data are refreshed.
   • Show current threshold is selected by default. Select Show dynamic threshold to update the threshold line when values change.

Study Scoring

1. Click Study Scoring in the left navigation.

   

2. Enter the Study Query (SQL statement).
3. Click Validate to validate the query and update as needed.
4. Click Save.

Risk Levels / Alerts

1. Select Risk Levels / Alerts in the left navigation.

   

Tolerance Limits

2. Enter values for:
   • Upper Limit
   • Approaching Upper Limit
   • Approaching Lower Limit
   • Lower Limit

The In Control (exclusive) limit is populated automatically.

• Validation prevents overlapping values.
• If an error message displays, click the 'X' and update the values.

The Gauge Preview updates as values are entered. Adjust the sample score using the slider.

Study Risk Alerts

3. Configure alerts for each tolerance level as needed.
4. Select a tolerance level, then click the Add icon.
5. Configure the alert:
   • Name: Select a configured alert from the drop-down.
   • Due in Days: Enter the required completion timeframe.
   • Trigger:
     • Always: The alert is displayed every time.
     • When Changed From Previous: The alert displays only when the score changes, either to a higher or lower risk level.
     • When Riskier Than Previous: The alert displays only when the score results in a higher risk level than before.
   • Assign To: Select a user, user group, or role from the drop-down.

Supporting Data

1. Select Supporting Data in the left navigation.

2. Add domains as supporting data for the QTL dashboard.

   

3. 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 exists, an error message displays.
4. Click the Add Domain icon in the Domains area to select from the available domains. Use the scrollbar to access all domains.
5. Continue adding as needed.
6. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.
7. Click the Delete icon to remove a domain.

Save QTL Configuration

1. Click Save to add the QTL to the listing.

   If configuration is incomplete or invalid, an error message displays. Review the message, click the 'X', and update the configuration.

Add QTL From Library

1. Select Add QTL From Library. The window opens.
2. Select one or more QTLs.
3. Click Save.

• QTLs already included in the study cannot be added again.
• QTLs include definitions from Risk Management Configuration.
• Study-specific scoring, thresholds, and alerts must be configured in RBQM.

Unlink a QTL From Library

The QTL is converted to a study-level QTL, and the checkmark in the Global column is removed.

1. Select Add QTL From Library. The window opens.
2. Clear the checkbox for the QTL.
3. Click Save.

A message displays confirming the update.

Edit a Study-Level QTL

1. Select the QTL row.
2. Click the Edit icon. The Edit QTL window opens.
3. Update fields as needed.
   • Name and Category cannot be edited if the QTL remains linked to Risk Management Configuration.
4. Click Save.

Delete a Study-Level QTL

Deleting a QTL removes it from the current study only. The source QTL in Risk Management Configuration and other studies is not affected.

1. Select the QTL row.
2. Click the Delete icon.
3. In the confirmation window, click OK or Cancel.

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

Configure Study KRIs

Key Risk Indicators (KRIs) define the metrics used in RBQM to monitor study risk at the site and country levels. KRIs can be created at the study level or added from Risk Management Configuration. KRIs added from the library include basic attributes, while study-specific scoring, thresholds, and alert logic are configured in RBQM.

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

1. In the left navigation, select Key Risk Indicators (KRI) under Study.
2. Review the KRI listing. Columns include: Name, Abbreviation, Description, Risk Indicator Guidance, Category, CTQ, Country, Site, Critical, Weight, Uses CSM, Active, Part of Current RACT, and Global.
   • A checkmark in the Global column indicates the KRI is linked to the library.

Add and Define a Study-Level KRI

1. On the Key Risk Indicators (KRIs) page, click the Add icon.
2. Select one of the following:
   • Add KRI: Create a new study-level KRI.
   • Add KRI From Library: Add an existing KRI from Risk Management Configuration.

Add KRI

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

   

General

1. Enter the following fields:
   • Name: Enter a KRI name.
   • Category: Select from the drop-down.
   • CTQ: Optionally link to a CTQ to support CTQ-level and trial-level risk assessment.
   • Abbreviation: Enter a value displayed in RBQM dashboards.
   • Description: Enter a description.
   • Risk Indicator Guidance: Enter recommended actions and next steps for central monitors when the KRI breaches its defined limit. The guidance displays in the side panel under the KRI Details tab in the Recommendation field.
   • Status: Inactive is selected by default. Toggle to activate so the KRI runs when data are refreshed.
   • Critical vs. Not Critical: KRI is Not Critical is selected by default. Select KRI is Critical to flag the KRI as 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.
   • Weight: Update if needed (default is 1).

Site Scoring

1. Select Site Scoring in the left navigation.

   

2. Optionally, select Use CSM (Central Statistical Monitoring) to enable statistical comparison across sites. 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.

   

   1. Configure the following:

      • CSM Type: Continuous, Discrete, or Proportion.
      • CSM Alpha Value: Select a threshold value: .1, 0.05, 0.01, 0.001, 0.0001, 0.00001, or 0.000001.
      • CSM Measurement Label: Enter a label (optional).
      • Sites Query: Enter the SQL statement.
      • Click Validate and update the query as needed.

      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.

3. Optionally, select is Z Score to enable Z-score calculations.
   Example: A dataset where most values are 0 with a few higher values is not suitable for Z-score analysis.
   • Use Z-scores only when:
     • Data are not categorical (for example, not yes / no or severity scales).
     • Data are not heavily skewed.
     • At least 30 observations are available.
4. Sites Query: Enter the SQL statement to return the maximum risk value for each site. This is a required entry.
5. Click Validate to review results and update as needed. A table displays the Site ID, Site Score, and Z-Score.

Site Risk Levels / Alerts

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).

1. Select Risk Levels / Alerts under Site Scoring.
   
2. Enter Site Risk Levels limits.
   • Validation prevents overlapping values.
   • If an error message displays, click the 'X' and update the values.

The Gauge Preview updates as values are entered. Adjust the sample score using the slider.

Site Risk Alerts

1. Select a risk level (for example, High, Medium, Low).
2. Click the Add icon.
3. Configure the alert:
   • Name: Select a configured alert from the drop-down.
   • Due in Days: Enter the required completion timeframe.
   • Trigger:
     • Always: The alert displays every time.
     • When Changed From Previous: The alert displays only when the score changes, either to a higher or lower risk level.
     • When Riskier Than Previous: The alert displays only when the score results in a higher risk level than before.
     • Assign To: Select a user, user group, or role from the drop-down.
4. Repeat for each risk level as needed.

Supporting Data

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

1. Select Supporting Data under Site Scoring.

   

2. Click the Get From Query icon in the Domains area to add domains from the Sites Query (in Site Scoring).
   • If no query exists, an error message displays.
3. Click the Add Domain icon in the Domains area to select available domains from the drop-down. Use the scrollbar to access all domains.
4. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.
5. Click the Delete icon to remove a domain.

Country Scoring

1. Select Country Scoring in the left navigation.

   

2. Enter the Countries Query, the SQL statement to return the maximum risk value for each country. This is a required entry.
3. Click Validate and update the query as needed.

Country Risk Levels / Alerts

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).

1. Select Risk Levels / Alerts under Country Scoring.
2. Enter Country Risk Levels limits.
   1. Validation prevents overlapping values.
   2. The Gauge Preview updates as values are entered.
3. Configure alerts using the same steps as Site Risk Actions.

Supporting Data

1. Select 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.
2. Click the Get From Query icon in the Domains area to add domains from the Countries Query (in Country Scoring).
3. Click the Add Domain icon in the Domains area to select available domains from the drop-down. Use the scrollbar to access all domains.
4. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.
5. Click the Delete icon to remove a domain.

Save KRI Configuration

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

Add KRI From Library

1. Select Add KRI From Library. The window opens.
2. Select one or more KRIs.
3. Click Save.

• KRIs already included in the study cannot be added again.
• KRIs include definitions from Risk Management Configuration.
• Study-specific scoring, thresholds, and alerts must be configured in RBQM.

Unlink a KRI From Library

The KRI is converted to a study-level KRI, and the checkmark in the Global column is removed.

1. Select Add KRI From Library. The Add KRI From Library window opens, with the KRIs in the study highlighted in blue.
2. Clear the checkbox for the KRI.
3. Click Save.

A message displays confirming the update.

Edit a Study-Level KRI

1. Select the KRI row.
2. Click the Edit icon. The Edit KRI window opens.
3. Update fields as needed.
   • Name and Category cannot be edited if the KRI remains linked to Risk Management Configuration.
4. Click Save.

Delete a Study-Level KRI

Deleting a KRI removes it from the current study only. The source KRI in Risk Management Configuration and other studies is not affected.

1. Select the KRI row.
2. Click the Delete icon.
3. In the confirmation window, click OK or Cancel.

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, finalized RACT assessments automatically add associated CTQs, QTLs, or KRIs to the study-level configuration. These items display with a checkmark in the Part of Current RACT column.
If a new RACT assessment is finalized and items are no longer included, an information icon displays with the message 'Removed from current RACT assessment'.

Configure Study Sites

Site-level monitoring requires a Sites table. Configuration cannot proceed until the Sites table is loaded.

Configure Site Query

1. In the left navigation, click Sites under Study. The SQL Query for Sites window opens.
2. Enter the SQL statement to define the Sites table source.
   • The statement must include the study, staging area, and table name.
   • The statement must include a country code for each site to enable country-level RBQM functionality.
   • Optional fields can be added to support enhanced RBQM analysis and reporting:
     • Site Milestone
     • Golden Site ID
     • Golden PI ID

These fields typically originate from a CTMS system. In the absence of a direct CTMS integration, they can be included in the Site query to enrich site-level data. When included, corresponding columns display in the Sites Overview dashboard to provide additional context for site performance and monitoring.

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

Note: Optional fields can be appended to the SELECT statement when available.

3. Click Preview.
   • The lower section displays the Sites table preview.
   • If results are not as expected, update the SQL statement.
4. Click Save.

Sites SQL Statement

If site data are not available from operational data, import a .xlsx or .txt file into elluminate, typically into the Operational staging area. The table must include Site ID and location fields (city, state, zip, country).

Configure Study Alerts

Study-level alerts define actions triggered when QTL or KRI thresholds are met.

1. In the left navigation, click Alerts under Study.
2. Review the Alerts listing, organized by Low, Medium, and High levels.

Add a Study-Level Alert

1. Click the Add icon.
2. Configure the alert:
   • Level: Select low, medium, or high from the drop-down.
   • Name: Select from the drop-down or enter a new alert.
     • Alerts are sourced from Risk Management Configuration.
     • New entries are added to the global list.
   • Due in Days: Enter the required completion timeframe.
   • Trigger:
     • Always: The alert displays every time.
     • When Changed From Previous: The alert displays only when the score changes, either to a higher or lower risk level.
     • When Riskier Than Previous: The alert displays only when the score results in a higher risk level than before.
3. Click Save.

Edit a Study-Level Alert

1. Select the alert name.
2. Update fields as needed:
   • Name
   • Due in Days
   • Trigger
3. Click Save.

Delete Study-Level Alert(s)

1. Select one or more alerts using the checkbox.
2. Click the Delete icon.
3. In the confirmation window, click OK or Cancel.