Enable Signal Calculations for Product Family Combinations

With the 26R1 release, you can configure your Vault to perform Signal Calculations at the Aggregate Reporting Group level, streamlining signal detection by allowing you to generate scheduled or ad-hoc Signal Calculation scores and Case counts across entire drug classes or therapeutic areas.

This feature allows users to run calculations that generate Statistical Data at the Aggregate Reporting Group-MedDRA Preferred Term (PT) level and the Aggregate Reporting Group-MedDRA query level, instead of the existing Product Family level.

After you have configured this feature, see Configure Signal Calculations Settings for Aggregate Reporting Groups for more information.

Overview

To configure your Vault to use Aggregate Reporting Groups rather than Product Families in your signal calculations:

Update Object Fields and Layouts

Update object fields and layouts for the following objects:

Update Product-Event Combination Object

To update the Product-Event Combination object:

  1. Navigate to Admin > Configuration > Objects > Product-Event Combination.
  2. On the Details tab, select Edit.
  3. In the Options section, update the Record Summary Fields as follows, then select Save:
    • Remove Primary Product Family
    • Add Aggregate Reporting Group
  4. Navigate to the Fields tab, then select Primary Product Family.
  5. Select Edit, then clear the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  6. Navigate to the Fields tab, then select Aggregate Reporting Group.
  7. Select Edit, then select the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  8. Navigate to the Layouts tab and select the appropriate layout.
  9. In the Details section:
    • Remove the Primary Product Family field
    • Add the Aggregate Reporting Group field, then move it to the top of the section
  10. In the PEC Period section, edit the default columns as follows:
    • Remove Primary Product Family
    • Add Aggregate Reporting Group
  11. Select Save.

Update PEC Period Object

To update the PEC Period object:

  1. Navigate to Admin > Configuration > Objects > PEC Period.
  2. On the Details tab, select Edit.
  3. In the Options section, update the Record Summary Fields as follows, then select Save:
    • Remove Primary Product Family
    • Add Aggregate Reporting Group
  4. Navigate to the Fields tab, then select Primary Product Family.
  5. Select Edit, then clear the Display in default lists and hovercards checkbox and select Save.
  6. Navigate to the Fields tab, then select Aggregate Reporting Group.
  7. Select Edit, then select the Display in default lists and hovercards checkbox and select Save.
  8. Navigate to the Layouts tab and select the appropriate layout.
  9. In the Details section:
    • Remove the Primary Product Family field
    • Add the Aggregate Reporting Group field, then move it to the top of the section
  10. For the Statistical Data, EVDAS eRMRs, Literature Data, and Documents sections, edit the default columns as follows:
    • Remove Primary Product Family
    • Add Aggregate Reporting Group
  11. Select Save.

Update Statistical Data Object

To update the Statistical Data object:

  1. Navigate to Admin > Configuration > Objects > Statistical Data.
  2. On the Details tab, select Edit.
  3. In the Options section, update the Record Summary Fields as follows, then select Save:
    • Remove Product Family
    • Add Aggregate Reporting Group
  4. Navigate to the Fields tab, then select Product Family.
  5. Select Edit, then clear the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  6. Navigate to the Fields tab, then select Aggregate Reporting Group.
  7. Select Edit, then select the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  8. Navigate to the Layouts tab and select the appropriate layout.
  9. In the Details section:
    • Remove the Product Family field
    • Add the Aggregate Reporting Group field, then move it to the top of the section
  10. Select Save.

Update Signal Product Profile Object

To update the Signal Product Profile object:

  1. Navigate to Admin > Configuration > Objects > Signal Product Profile > Fields > Product Family.
  2. Select Edit, then clear the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  3. Navigate to the Fields tab, then select Aggregate Reporting Group.
  4. Select Edit, then select the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  5. Navigate to the Layouts tab and select the appropriate layout.
  6. In the Details section:
    • Remove the Product Family field
    • Add the Aggregate Reporting Group field, then move it to the top of the section
  7. Select Save.

Update Signal Reporting Period Object

To update the Signal Reporting Period object:

  1. Navigate to Admin > Configuration > Objects > Signal Reporting Period.
  2. On the Details tab, select Edit.
  3. In the Options section, update the Record Summary Fields as follows, then select Save:
    • Remove Product Family
    • Add Aggregate Reporting Group
  4. Navigate to the Fields tab, then select Product Family.
  5. Select Edit, then clear the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  6. Navigate to the Fields tab, then select Aggregate Reporting Group.
  7. Select Edit, then edit the checkbox selections as follows and select Save:
    • Select Display in default lists and hovercards
    • Clear Do not copy this field in Copy Record
  8. Navigate to the Fields tab, then select Signal Product Profile.
  9. Select Edit, then replace the Criteria VQL field value with the following and select Save: aggregate_reporting_group__v = {{this.aggregate_reporting_group__v}}
  10. Navigate to the Layouts tab and select the appropriate layout.
  11. In the Details section:
    • Remove the Product Family field
    • Add the Aggregate Reporting Group field, then move it to the top of the section
  12. For the Statistical Data, PEC Periods, and Safety Investigations sections, edit the default columns as follows:
    • Remove Product Family
    • Add Aggregate Reporting Group
  13. Select Save.

Update Safety Investigation Object

To update the Safety Investigation object:

  1. Navigate to Admin > Configuration > Objects > Safety Investigation.
  2. On the Details tab, select Edit.
  3. In the Options section, update the Record Summary Fields as follows, then select Save:
    • Remove Product Family
    • Add Aggregate Reporting Group
  4. Navigate to the Fields tab, then select Product Family.
  5. Select Edit, then clear the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  6. Navigate to the Fields tab, then select Aggregate Reporting Group.
  7. Select Edit, then select the following checkboxes depending on your business needs and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  8. Navigate to the Layouts tab and select the appropriate layout.
  9. In the Details section:
    • Remove the Product Family field
    • Add the Aggregate Reporting Group field, then move it to the top of the section
  10. For the Products and PEC Periods sections, edit the default columns as follows:
    • Remove Product Family
    • Add Aggregate Reporting Group
  11. Select Save.

Update Safety Investigation Product Object

To update the Safety Investigation Product object:

  1. Navigate to Admin > Configuration > Objects > Safety Investigation Product > Fields > Product Family.
  2. Select Edit, then clear the following checkboxes and select Save:
    • User must always enter a value (required)
    • Display in default lists and hovercards
  3. Navigate to the Fields tab, then select Aggregate Reporting Group.
  4. Select Edit, then edit the checkbox selections as follows and select Save:
    • Select Display in default lists and hovercards
    • Clear Do not copy this field in Copy Record
  5. Navigate to the Layouts tab and select the appropriate layout.
  6. In the Details section, move the Aggregate Reporting Group field to the top of the section.
  7. Select Save.

Update EVDAS eRMR Data Object

To update the EVDAS eRMR Data object:

  1. Navigate to Admin > Configuration > Objects > EVDAS eRMR Data.
  2. On the Details tab, select Edit.
  3. In the Options section, update the Record Summary Fields as follows, then select Save:
    • Remove Product Family
    • Add Aggregate Reporting Group
  4. Navigate to the Fields tab, then select Product Family.
  5. Select Edit, then clear the Display in default lists and hovercards checkbox and select Save.
  6. Navigate to the Fields tab, then select Aggregate Reporting Group.
  7. Select Edit, then select the Display in default lists and hovercards checkbox and select Save.
  8. Navigate to the Layouts tab and select the appropriate layout.
  9. In the Details section:
    • Remove the Product Family field
    • Add the Aggregate Reporting Group field, then move it to the top of the section
  10. Select Save.

Update Permission Sets

Ensure your permission sets are updated to grant the appropriate level of access for users according to your organization’s process. We recommend modifying the appropriate permission sets such that the Aggregate Reporting Group and Reporting Group Product Family object permissions match the existing Product Family object permissions.

For example, the Signal Management permission set provides Read access to the Product Family object. To update the Signal Management permission set for this feature, select the Read checkbox for the Aggregate Reporting Group and Reporting Group Product Family objects.