Configure RBQM in Data Central Configuration

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Permissions: Users must have RBM, Data Central, and Study Configure privileges to configure a study for RBQM.

RBQM (Risk Based Quality Management) is configured for a study within Data Central Configuration. 

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.
Config_1.png

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

RBQM DC Configuration.png

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

Expand the Global and Study section using the RBQM down arrows. Initially, the overview window displays 'Complete Configuration,' but each section within Global and Study requires configuration. 

Global configurations apply to all the RBQM studies within the URL; study-specific configurations apply only to the selected study. 

Important: Any edits or deletions at the Global level apply to every study in the URL.

Clicking Global in the left navigation displays the Global configuration overview.

Clicking Study in the left navigation displays the Study configuration overview.

Configure Global Categories

A set of standard global categories is available by default: Data Quality, Essential Documents, Investigational Product, Issue Management, Safety, Staffing, Facilities and Supplies, and Subject Recruitment and Discontinuation. These categories form the initial organizational layer for indicators.

Categories can be added, edited, or deleted as needed and are client-specific. 

In the left navigation, click Categories under Global.

Add a Global Category

  1. Click the Add icon (the plus sign) in the top right corner.
  2. Enter the name of the new category in the Name field.
  3. Click Save. This adds the category to the global list and will be available to all RBQM studies across the URL.

Edit a Global Category

  1. Click the category Name you want to edit.
  2. Edit the Name of the category.
  3. Click Save. The updated category displays in the list of Categories.

Delete Global Category(ies)

  1. Click in the box at the left of the category(ies) you want to delete.
  2. Click the Delete icon (the trashcan) in the top right corner.
  3. A confirmation window opens. Click OK (or click Cancel to cancel your action).
  4. Click Save.

Configure Global Actions

Use Global Actions to configure actions that may be assigned to different indicators at the Study level. A set of default Actions display, but Actions can be added, edited, deleted, or disabled.

In the left navigation, click Actions under Global.

Add a Global Action

  1. Click the Add icon (the plus sign) in the top right corner. A new row is added at the top of the list.
  2. Enter the name of the new action in the Name field.
  3. Click Save. The new action is added to the end of the list.

Edit a Global Action

  1. Click the Action name you want to edit.
  2. Edit the Name of the action.
  3. Click Save. The updated action displays in the list of Actions.

Delete Global Action(s)

  1. Click in the box at the left of the action(s) you want to delete.
  2. Click the Delete icon (the trashcan) in the top right corner.
  3. A confirmation window opens. Click OK (or click Cancel to cancel your action).
    Global Actions in use cannot be deleted. A warning message displays; click the 'x' to close the message and cancel your actions. 
  4. Click Save.

Disable Global Action(s)

Actions marked as disabled are not available in the drop-down when assigning to different indicators at the Study level. Disabled actions stop firing future KRI and QTL issues.

  1. Click in the box in the Disabled column of the action(s) you want disabled. To re-enable action(s), uncheck the box(es) in the Disabled column.
  2. Click Save.
  3. A confirmation window opens. Click OK (or click Cancel to cancel your action).

Configure Global Indicators

Global Indicators identify the Category, Name, and Description of a possible Key Risk Indicator. Indicators are used to determine how risky an activity is; they provide an early signal of increasing risk exposures in the various categories. Global Indicators can be added here and will be available across the URL for all RBQM studies.

In the left navigation, click Indicators under Global.

Add a Global Indicator

  1. Click the Add icon (the plus sign) in the top right corner. A new row is added at the top of the list.
  2. Select the Category from the Category drop-down.
  3. Enter the name of the new indicator in the Name field.
  4. Click Save. The new indicator is added to the end of the list.

Edit a Global Indicator

  1. Click the Indicator name you want to edit.
  2. Edit the Category, Name, or Description of the Indicator.
  3. Click Save. The updated indicator displays in the list of Indicators.

Delete Global Indicator(s)

  1. Click in the box at the left of the indicator(s) you want to delete.
  2. Click the Delete icon (the trashcan) in the top right corner.
  3. A confirmation window opens. Click OK (or click Cancel to cancel your action).
    Global Indicators in use cannot be deleted. A warning message displays; click the 'x' to close the message and cancel your actions. 
  4. Click Save.

Configure Study CTQs

CTQs, or Critical to Quality Factors, are essential tools for ensuring study reliability, integrity, and regulatory compliance by managing quality and risk. While not required, adding CTQs is recommended. They are added manually; if none are added, the 'View CTQ' toggle on the study dashboard will be disabled.

Add and Define a Study-Level CTQ

  1. From the CTQ Factors list, click the Add icon (the plus sign) in the top right corner. The New CTQ window opens.
    Add CTQ.png
  2. Enter the CTQ name in the Name field.
  3. Select the Category from the drop-down.
  4. Select one or more associated Acceptable Range(s) (QTL) from the drop-down.
  5. Enter the Description. 
  6. Status: By default, Active is selected. Being active, it will run when new data are refreshed. 
  7. Click Save.

Edit a Study-Level CTQ

  1. Click in the row of the CTQ you want to edit.
  2. Click the Edit icon. The Edit CTQ window opens.
  3. Make changes as needed.
  4. Click Save. 

Delete a Study-Level CTQ

  1. Click in the row of the CTQ you want to delete.
  2. Click the Delete icon (the trashcan). 
  3. A confirmation window opens. Click OK (or click Cancel to cancel your action).
  4. Click Save. 

Configure Study QTLs

QTLs, or Quality Tolerance Limits, are used to measure the health of a study. They can be imported from the Global Library or added manually for each study. Configured QTLs can be promoted to the Global Library to be used across studies. For details on using the Global Library for QTLs and KRIs, see the section within this article Use the Global Library to Promote or Import QTLs and KRIs.

In the left navigation, click Quality Tolerance Limits (QTLs) under Study. Added QTLs are displayed in the list with columns for Name, Description, Category, CTQ, and Active status. 

Add and Define a Study-Level QTL

  1. From the list, click the Add icon (the plus sign) in the top right corner. The New Quality Tolerance Limits (QTL) window opens, displaying the General window.
    Add QTL.png

    General

  2. Enter the QTL name in the Name field.
  3. Select the Category from the drop-down.
  4. Enter the Description. The entered description will display when a user hovers over a QTL gauge.
  5. Status: By default, Inactive is selected. Click the toggle to activate it so that it will run when new data are refreshed.
  6. By default, Show current threshold is selected (the threshold line will be 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 

  7. Click Study Scoring in the left navigation.
    New QTL Scoring.png
  8. Enter the Study Query, the SQL statement.
  9. Click the Validate button to validate the query. Modify query as needed.
  10. Click Save.

    Risk Levels / Actions

  11. Click Risk Levels / Actions in the left navigation.
    QTL Risk Levels - Actions.png
    Tolerance Limits
  12. Enter the Tolerance Limits for Upper Limit, Approaching Upper Limit, Approaching Lower Limit, and Lower Limit. The In Control (exclusive) limit will be automatically populated.
  13. 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.
  14. As values are entered, the Gauge Preview on the right will update so you can see what the configured gauge will look 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.

  15. Click one of the Tolerance Limits to create a Study Risk Action for that limit.
  16. Click the Add icon (the plus sign).
  17. Click in the Name field and select the action from the drop-down (as configured in Global Actions).
  18. Enter the number of days in the Due in Days field in which this action should be completed once the QTL enters the risk level.
  19. Click in the Trigger field and select from the drop-down: Always (i.e. when the score exceeds a threshold a system generated issue will always be generated), When Changed From Previous (i.e. when you want the action to display only when there is a change in the score; the change could be a higher or lower risk), or When Riskier Than Previous (i.e., when you want the action to display only if the score results in a higher risk level).
  20. 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

  21. 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.
    QTL Supporting Data.png

  22. 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. 
  23. 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.
  24. Continue adding as needed.
  25. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.
  26. To remove a domain, click the Delete icon next to a domain.

    Save QTL Configuration

  27. 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 will display. Read the message carefully, then click the 'x' to close it and correct the item(s).

Edit a Study-Level QTL

  1. Click in the row of the QTL you want to edit.
  2. Click the Edit icon. The Edit QTL window opens.
  3. Make changes as needed.
  4. Click Save. 

Delete a Study-Level QTL

  1. Click in the row of the QTL you want to delete.
  2. Click the Delete icon (the trashcan). 
  3. A confirmation window opens. Click OK (or click Cancel to cancel your action).
  4. Click Save. 

Note: QTLs used in a Risk Action Plan within RACT cannot be deleted; a message will appear indicating this. 

Configure Study KRIs

In the left navigation, under Study, click Key Risk Indicators (KRIs). Added KRIs will display in the list of Indicators, with columns for Name, Description, Category, Country (checked if a Countries query exists), Site (checked if a Sites query exists), Weight, Uses CSM (checked if a CSM calculation is applied), Active (checked if active), and Global (checked if assigned from the Global KRI library). 

The list is initially empty. Global Indicators can be assigned to your study using the pre-defined Category, Name, and Description; they can be imported from the Global Library or added manually. Configured KRIs can be promoted to the Global Library for use across studies. For details on using the Global Library for QTLs and KRIs, see Use the Global Library to Promote or Import QTLs and KRIs in this article.

Add and Define a Study-Level KRI

When adding an indicator at the study level, it is only available for that study and does not appear at the global level.

  1. From the Indicators list, click the Add icon (the plus sign) in the top right corner. The New Indicator window opens.
    New KRI.png
    General
  2. Enter the KRI name in the Name field.
  3. Select the Category from the drop-down.
  4. Enter the Description.
  5. Update the Status: By default, Inactive is selected. Click the toggle to activate it so that it will run when new data are refreshed.
  6. Update Critical Vs. Not Critical: By default, KRI is Not Critical is selected. Click KRI is Critical to mark the KRI as critical. If a site exceeds the threshold for a KRI defined as critical, the entire site will be flagged as yellow / red, regardless of the overall site score.
  7. Update the Weight if needed (1 is default).

    Scoring
    Optionally, use CSM or Z Score for scoring.
  8. Click Site Scoring in the left navigation.
    New KRI Site Scoring.png
  9. 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.
    New KRI Site Scoring CSM.png
    1. Select the CSM Type from the drop-down: Continuous, Discrete, or Proportion.
    2. Select the CSM Alpha Value from the drop-down: .1, 0.05, 0.01, 0.001, 0.0001, 0.00001, or 0.000001.
    3. Optionally, add the CSM Measurement Label.
    4. Enter the Sites Query.
    5. Click the Validate button to validate the query. Modify query as needed.
    6. Continue to Risk Levels, Step 13.
  10. Optionally, 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.
  11. Enter the Sites Query, the SQL statement to call the max risk value for each site for the selected indicator. This is a required entry.
  12. Click the Validate 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 / Actions
    Enter Limits. For example, when looking at enrollment numbers, the lower the number, the higher the risk. Or you may have an AE rate that is too high or too low (e.g., there is a good band in between).

  13. Click Risk Levels / Actions under Site Scoring in the left navigation.
    New KRI Risk Levels - Actions.png
  14. Enter the Site Risk Levels. The Low will be automatically populated.
  15. Edit checks are in place to identify if overlapping values are entered. When Save is clicked, an error message will display, click the 'x' to close the message and update the values.
  16. As values are entered, the Gauge Preview on the right will update so you can see what the configured gauge will look like. Update the Sample Score by using the slider.

    Site Risk Actions: High
    Apply actions if an indicator exceeds the limit.
  17. Click one of the Site Risk Levels, i.e., High (Upper), Medium (Upper), Low (exclusive), Medium (Lower), or High (Lower).
  18. Click the Add icon (the plus sign).
  19. Click in the Name field and select the action from the drop-down (as configured in Global Actions).
  20. 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.
  21. Click in the Trigger field and select from the drop-down: Always (i.e. when the score exceeds a threshold a system generated issue will always be generated), When Changed From Previous (i.e. when you want the action to display only when there is a change in the score; the change could be a higher or lower risk), or When Riskier Than Previous (i.e. when you want the action to display only if the score results in a higher risk level).
  22. Click in the Assign To field and select from the drop-down: Data Central role Site Monitor (default), or select from the list.
  23. Continue adding Site Risk Actions for each Site Risk Level as needed.

    Supporting Data
  24. 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.
    NewKRI_SupportingData.png

  25. 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.
  26. 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.
  27. Continue adding as needed.
  28. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.
  29. To remove a domain, click the Delete icon next to a domain.


  30. Click Country Scoring in the left navigation.
    CountryScoring.png
  31. 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.
  32. Click the Validate button to validate the query. Modify query as needed.

    Country Risk Levels / Actions
    Enter the Country Risk Levels limits. For example, when looking at enrollment numbers, the lower the number, the higher the risk. Or you may have an AE rate that is too high or too low (e.g., there is a good band in between).
  33. Click Risk Levels / Actions under Country Scoring in the left navigation.
    New KRI Country Scoring Risk Levels - Actions.png
  34. Enter the Country Risk Levels limits. The Low will be automatically populated.
  35. Edit checks are in place to identify if overlapping values are entered. When Save is clicked, an error message will display, click the 'x' to close the message and update the values.
  36. As values are entered, the Gauge Preview on the right will update so you can see what the configured gauge will look 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.
  37. Click one of the Country Risk Actions, i.e., High (Upper), Medium (Upper), Low (exclusive), Medium (Lower) or High (Lower).
  38. Click the Add icon (the plus sign).
  39. Click in the Name field and select the action from the drop-down (as configured in Global Actions).
  40. 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.
  41. Click in the Trigger field and select from the drop-down: Always, When Changed From Previous (i.e. when you want the action to display only when there is a change in the score; the change could a higher or lower risk), or When Riskier Than Previous (i.e. when you want the action to display only if the score results in a higher risk level).
  42. Click in the Assign To field and select from the drop-down: Data Central role Site Monitor (default), or select from the list.
  43. Continue adding Country Risk Actions for each Country Risk Level as needed.

    Supporting Data
  44. 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.
  45. 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.
  46. 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.
  47. Continue adding as needed.
  48. Click the Preview Domain icon (the magnifying glass) next to a domain to view the domain listing in the Preview window.
  49. To remove a domain, click the Delete icon next to a domain.


    Save KRI Configuration

  50. Click Save. The new KRI is added to the list; note that the 'Global' column is not checked. This column will be checked if a global indicator was brought into the study.

Edit a Study-Level KRI

  1. Click in the row of the Indicator you want to edit.
  2. Click the Edit icon. The Edit KRI window opens.
  3. Make changes as needed.
  4. Click Save. 

Delete a Study-Level KRI

  1. Click in the row of the Indicator you want to delete.
  2. Click the Delete icon (the trashcan). 
  3. A confirmation window opens. Click OK (or click Cancel to cancel your action).
  4. Click Save. This is just removing the Indicator from this study; it is not deleting a Global Indicator.

Note: KRIs used in a Risk Action Plan within RACT cannot be deleted; a message will appear stating this.

Assign Global Indicators to the Study

  1. From the Indicators list, click the Assign icon in the toolbar. The Assign Indicator window opens. The Global Indicators are grouped by the Global Categories.
  2. Check any of the Global Indicators to be assigned to the study.
  3. The Indicator displays in the list and Global is checked.

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

SQL Portion
Required SQL
Location
Study Name Schema Prefix

From the ETL tab when study is in Edit mode:

RBM_SQL_StudyName.png
Staging Area Schema Suffix

Administration > Configuration > Staging Areas (click to edit the staging area):

RBM_SQL_StagingArea.png
Table Name Table Name

At the study level, click Exporter and select the Staging Area with the table to see the name:

RBM_SQL_TableName.png

Note: To ensure you are seeing the correct name, be sure your My Profile is set to Names.

RBM_SQL_Preferences.png

 

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:

RBM_Excel.png

Configure Study Actions

Use the Study > Actions to configure study-level actions. These pull from the Global Actions. 

In the left navigation, click Actions under Study.

The list of Actions is displayed in Low, Medium, and High sections. Actions at the study level can be added and deleted. 

Add a Study-Level Action

  1. Click the Add icon (the plus sign) in the top right corner within the section (low, medium, high) where you want to add the action.
  2. Click in the Name field and select the action from the drop-down (as configured in Global Actions), or manually enter an Action (it will automatically be entered to Global Actions).
  3. Enter the Due in Days field in which this action should be completed once the QTL or KRI enters the risk level.
  4. Click in the Trigger field and select from the drop-down: Always, When Changed From Previous (i.e. when you want the action to display only when there is a change in the score; the change could a higher or lower risk), or When Riskier Than Previous (i.e., when you want the action to display only if the score results in a higher risk level).
  5. Click Save. 

Note: Actions added at the study level will appear in the global list.

Edit a Study-Level Action 

  1. Click the Action name you want to edit.
  2. Edit the Name of the action, Due in Days, and / or Trigger.
  3. Click Save. The updated action displays in the list of Actions.

Delete Study-Level Action(s)

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

Use the Global Library to Promote or Import QTLs and KRIs

In addition to creating a study level QTL or KRI (or assigning a Global KRI), it is also possible to utilize the Global Library in elluminate to share configured QTLs and KRIs between studies. The options are to promote a QTL / KRI to the Global Library and import a QTL / KRI from the Global Library. The process is the same for both QTLs and KRIs.

Promote a QTL / KRI

Promoting a QTL or KRI to the Global Library will make it available to other studies in the same URL / environment.

  1. From the list of QTLs / KRIs, click the row to be promoted.
  2. Click the Global Library button. The drop-down options are Promote to Global Library and Import From Global Library.
  3. Select Promote to Global Library. The Promote to Global Library window opens.
  4. Library Title: By default, this is auto-filled with the name of the QTL /KRI.
  5. Description: By default, this is auto-filled with the description in the QTL / KRI.
  6. Tags: Optionally, enter a comma separated list of tags that can be used to find QTLs / KRIs when importing from the Global Library.
  7. Folder: Select the folder where the QTL / KRI will be located. The Home folder is selected by default. Users with the Global Library Configure privilege can also create, modify, or delete folders.
  8. Scope: Select the Scope by clicking the down arrows to expand the Therapeutic Areas, Compounds, and Programs sections and checking the box(es) to make your selections. User the scrollbar at the right of each category to see all items listed. The selected Scope defines which studies will have the QTL / KRI available.
  9. Click Save.

Import a QTL / KRI from the Global Library

  1. From the list of QTLs / KRIs, click the Global Library button. The drop-down options are Promote to Global Library and Import From Global Library.
  2. Select Import From Global Library. The Import From Global Library window opens.
  3. Enter a New Name.

  4. Optionally, use the Filter Library Objects. By default, the filter automatically applies attributes of the current study, so the user sees the most applicable available QTL / KRI objects. The number in the blue badges indicate the number of selected items in each area (TA, Compounds, Programs). Additional filters can be applied, or filters can be removed.

    1. Click the down arrows to expand the Therapeutic Areas, Compounds, and / or Programs sections. 
    2. Check the items you wish to filter.

    To reset the filter, click Reset.
    The window updates based on your selections. Notice the blue badges update to the number of filtered objects displayed.

  5. Find the QTL / KRI object within the folder structure, or use the Search field to filter the list, to be imported. Use the scrollbar to see all items.
  6. Click the QTL / KRI object to be imported.
  7. Click Save.

    Tip: Once the QTL is imported and appears in the list of Tolerance Limits, update its attributes accordingly for the study.

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