Enable Advanced (EBGM) Calculation for Safety Data

Learn how to configure your Vault to support Empirical Bayes Geometric Mean (EBGM) signal detection calculations.

About the Feature

With the 24R3 release, users can now run advanced EBGM calculations on Safety data in addition to simple SQL calculations. EBGM is an advanced statistical method that allows users to measure the frequency of an adverse event occurring for a specific Product compared to the frequency of occurrence in other Products in the Safety database.

After you have configured this feature, see the following articles for more information:

• Configure Signal Calculation Objects
• Signal Detection Calculations

Update the Signal Calculation Mapping Object

To update the Signal Calculation Mapping object, navigate to Admin > Configuration > Objects > Signal Calculation Mapping and update the object layout and list layout.

Update the Object Layout

To update the Signal Calculation Mapping object layout:

1. Navigate to Layouts > Signal Calculation Mapping Detail Page Layout.
2. Ensure the Details section includes the following fields:
   • Signal Calculations Setting
   • Signal Calculation
   • Calculation Output Value
   • Target Field Name
3. Select Save.

Update the List Layout

To update the Signal Calculation Mapping list layout:

1. Navigate to the List Layout tab and select Reorder.

2. Drag field names so the list layout appears in the following order:
   • Name
   • Signal Calculation Setting
   • Signal Calculation
   • Calculation Output Value
   • Target Field Name
3. Select Save.

Update the Signal Calculation Object

To update the Signal Calculation object, navigate to Admin > Configuration > Objects > Signal Calculation and perform the following configuration:

• Set the Calculation field to display in default lists and hovercards.
• Insert a Signal Calculation Mapping section to the layout.
• Add a layout rule.
• Update the list layout.

Update the Calculation Field

Update the Calculation field to display in default lists and hovercards:

1. Select the Fields tab.
2. Select Calculation.
3. Select Edit.
4. Select the Display in default lists and hovercards checkbox.
5. Select Save.

Update the Signal Calculation Layout

Update the Signal Calculation object layout with the Signal Calculation Mapping related object section:

1. Navigate to Layouts > Signal Calculation Detail Page Layout.
2. Select Edit.
3. After the Details section, insert a related object section with the following information:
   • Related Object: From the drop-down, select Signal Calculation Mapping.
   • Section Label: Enter Signal Calculation Mapping.
   • Creation Option: Select Create record in new page.
4. Select Done.
5. Select Save.

Add a Layout Rule

Add a layout rule to hide certain fields when the Query Type is not set to Advanced:

1. Navigate to Layouts > Signal Calculation Detail Page Layout.
2. Select Layout Rules.
3. Select Create.
4. On the Create Layout Rule page, complete the following information and then select Save:
   • Label: Enter Hide if not Advanced.
   • Description: (Optional) Enter Hide fields only applicable to advanced calculations.
   • If this Layout Rule Expression is TRUE: Enter Not(query_type__v = 'advanced__v').
   • Apply the following display effects:

   Effect	Type	Values
   Hide	Sections	Calculation Output Mapping
   Hide	Fields	Calculation

Update the List Layout

To update the Signal Calculation list layout:

1. Navigate to the List Layout tab.
2. Select Reorder.
3. Drag field names so the list layout appears in the following order:
   • Name
   • Signal Calculation Setting
   • Signal View
   • Query Type
   • Calculation
4. Select Save.

Update the Statistical Data Object

To update the Statistical Data object, navigate to Admin > Configuration > Objects > Statistical Data and perform the following configuration:

• Set the fields to display in default lists and hovercards.
• Update the layout.
• Update the list layout.

Update Fields

Update the EB05 and EB95 fields to display in default lists and hovercards:

1. Select the Fields tab.
2. Select EB05.
3. Select Edit.
4. Select the Display in default lists and hovercards checkbox.
5. Select Save.
6. Repeat the above steps for the EB95 field.

Update the Layout

To update the Statistical Data object layout:

1. Navigate to Layouts > Statistical Data Detail Page Layout.
2. In the Data section, add the following fields:
   • EBGM
   • EB05
   • EB95
3. Select Save.

Update the List Layout

To update the Statistical Data list layout:

1. Navigate to the List Layout tab and select Reorder.
2. Drag field names so the list layout appears in the following order:
   • Statistical Data Unique Name
   • Product Family
   • MedDRA Term
   • Alert
   • Listed
   • New All
   • Cumulative All
   • New Fatal
   • Cumulative Fatal
   • New Serious
   • Cumulative Serious
   • New Spontaneous
   • Cumulative Spontaneous
   • EB05
   • EB95
   • EBGM
   • Current Disposition
   • Current Disposition Date
   • Previous Period Disposition
   • Previous Period Disposition Date
   • Detection Date
   • Detection Type
   • Reporting Period
   • Source
   • Safety Investigation
3. Select Save.

Grant Object Permissions

Ensure your permission sets are updated to grant the appropriate level of access for Admins and users to objects and fields according to your organization’s process. Manage object permissions from Admin > Users & Groups > Permission Sets > [Permission Set] > Objects > [Object].

The following table summarizes the recommended level of access for your permission sets:

Permission Set	Object	Objects/Fields	Permissions
[Applicable Admin Permission Set] and [Applicable User Permission Set]	Statistical Data	(Optional) Object: Statistical Data Fields: EBGM EB05 EB95	Edit access for object permissions Read access for object and field permissions
[Applicable User Permission Set]	Signal Calculation Mapping	Object: Signal Calculation Mapping	Read, Create, Edit, and Delete access